jobs that crossed my desk through sept. 2, 2013€¦ · 02/09/2013 · able to post these every...

Jobs That Crossed My Desk Through Sept. 2, 2013 Complimentary Service of Audreysnetwork.com

Sept. 2, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

*************************************************************************** http://www.linkedin.com/jobs2/view/7017873?trk=eml-anet_dig-b_premjb-ttl-cn Pharmaceutical Territory Manager GrantProSearch - San Jose Posted 7 days ago

Experience Mid-Senior level

Job function Sales

Employement type Full-time

Industry Pharmaceuticals

Job ID 7017873

Job description The Pharmaceutical territroy manager will drive territory growth and profitability by delivering effective sales presentations to physicians in their territory. Candidates can live in the San Jose or East Bay. Territory requires 30% travel and includes San Jose, Monterey to fremont/Livermore to Fresno/Visalia. Desired Skills and Experience Bachelor in Life Science, Marketing or Business degree Minimum of 3 yrs plus experience in Pharmaceutical salesor Business to Business sales with account ownership Documentation Excellent planning and organizational skills Passionate about the providing strong customer relationships and follow up

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********************************************************************** Apply on company website Sr. Scientist/Scientist- Oncology Biomarker Development Genentech - US - California,South San Francisco Posted 7 days ago

Experience Associate

Job function Research, Science


Industry Biotechnology, Pharmaceuticals

Employer job ID 00408792

Job ID 5616835

Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech's Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and/or pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development. All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies. For this particular position, a strong background in cancer immunotherapy or the biology of the tumor microenvironment, evidenced by peer reviewed publications in top tier journals, would be an important asset. The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences. As a Scientist / Sr. Scientist, you are expected to: Provide exceptional scientific leadership within OBD, as well as to other functions,

subteams / teams at Genentech / Roche Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs

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Drive scientific and technical innovation collaboratively with other members of the Department Lead one or more biomarker subteams

Develop and execute on lead and exploratory biomarker strategies for one or more projects

Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment

Publish in high quality scientific, technical or medical journals Represent OBD externally through presentations at key National / International meetings,

interactions with our key investigators Participate and thrive in an interactive, team oriented culture

Who You Are PhD, MD or PhD/MD degree in a relevant scientific field (e.g. pathology, molecular biology, cancer genetics, cancer biology, molecular oncology) Minimum of 5-10 years post-doctoral experience in basic or translational research either in an academic and/or industry setting

Experience in clinical drug development and biomarkers is beneficial, including basic or advanced understanding of critical development functions, e.g. Clinical Pharmacology, Regulatory, Safety, Operations, Biostatistics, etc. At least 3 years of prior experience managing a group of research associates

Consistent record of cutting edge research and / or clinically-related science as evidenced by first- or senior-authored publications in top-tier journals

Recognized scientific leadership as documented by references and external presentations Outstanding presentation and communication skills Ability to lead, influence and motivate others Able to distill complex issues and clearly articulate solutions Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment

************************************************************************* Apply on company website Acthar Specialist, Rheumatology Questcor Pharmaceuticals, Inc. - US-CA-San Francisco Posted 19 days ago

Experience Not Applicable

Job function Sales, Business Development, Marketing


Industry Biotechnology, Hospital & Health Care, Pharmaceuticals


Job ID 6492867

Job description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of

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2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Acthar Specialist, Rheumatology. Responsibilities: The successful candidate will be able to show documented success as a top producer. They will effectively manage their territory as a results-oriented sales person, business partner and consultant. They will develop strategically targeted, accounts and specific business plans that reflect an in-depth understanding of local, regional and national market forces impacting product sales. The incumbent will skillfully deal with the concepts and complexities associated with the products and adjunctive therapies and must demonstrate an in-depth understanding of the clinical data. Qualifications: Bachelor degree and/or 3-5 years pharmaceutical sales experience; Rheumatology experience required; Local travel; some overnight required (10-20%). Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. ************************************************************************** Apply on company website For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Associate Director, Healthcare Professional (HCP) Marketing Questcor Pharmaceuticals, Inc. - US-CA-Hayward Posted 14 days ago


Job function Advertising, Marketing, Product Management




9/2/2013 5

Job ID 6179139

Job description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Associate Director, Healthcare Professional (HCP) Marketing. Responsibilities: Work cross-functionally with commercial team members (marketing, sales, analytics,

reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of Multiple Sclerosis business goals;

Lead and manage HCP promotion and planning team Manage presence at medical meetings; Manage ad agency and other vendors in development of materials and tactics; Develop strong relationships with KOLs (key opinion leaders); Develop and implement best-in-class speaker programs to support field sales efforts; Effectively interact with sales force and handle MS field requests; Provide input to development and implementation of annual marketing plans; Manage allotted budget while maximizing effectiveness of resources and funds; (Possible direct reports). Qualifications: BA/BS degree, preferably marketing. MBA Degree preferred; Minimum 5+ yrs of bio/pharmaceutical brand management responsibilities including

experience working on projects that involved developing promotional materials and working with Key Opinion Leaders;

2 yrs of successful experience in specialty pharmaceutical sales preferred; Management experience preferred Interactive experience (web/online/websites/CRM/iPad/etc.) a plus; Strong ability to management multiple projects simultaneously and work independently

when appropriate. Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. *************************************************************************

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Apply on company website For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing Questcor Pharmaceuticals, Inc. - US-CA-Hayward Posted 7 days ago






Job ID 6642919

Other Details About this job Job description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. The successful candidate will be responsible for developing and executing in-line product marketing efforts for Questcor’s key promoted product ACTHAR in DM/PM under the direction and leadership of the Director, DM/PM Rheumatology Marketing. The candidate will work with field sales, vendors and ACTHAR team members to develop and execute highly effective, results-driven marketing initiatives to maximize product opportunities and revenues in DM/PM. This position is located at Questcor’s corporate office in Hayward, CA. Responsibilities: Work cross-functionally with commercial team members (marketing, sales, analytics,

reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of business goals.

Manage ad agency and other vendors in development of materials and tactics.

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Develop strong relationships with key opinion and physician advisory board members. Develop and implement best-in-class speaker programs to support field sales efforts. Effectively interact with sales force and handle Rheumatology field requests. Contribute to the development and implementation of annual product marketing plans. Manage allotted budget at or below plan while maximizing effectiveness of resources

and funds. Qualifications: Bachelor degree required, MBA degree preferred. Minimum of 3 years of bio/pharmaceutical brand management responsibility including

experience working on projects that involved developing promotional materials and working with Key Opinion Leaders.

Minimum of 2 years successful experience in pharmaceutical sales (preferred) Strong ability to manage multiple projects simultaneously and work independently when

appropriate. Excellent leadership, teamwork, communication and relationship-building skills. Strong project management and communications skills. Rheumatology Experience Preferred. Overnight travel as required (25-30%). Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. ************************************************************************** Apply on company website For more information, you may view our website at http://www.questcor.com/careers/company-benefits. Senior Product Manager / Product Manager, Nephrology Marketing Questcor Pharmaceuticals, Inc. - US-CA-Hayward Posted 7 days ago






Job ID 5945978

Other Details About this job Job description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of

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2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager / Product Manager, Nephrology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. Responsibilities: Work cross-functionally with commercial team members (marketing, sales, analytics,

reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of Nephrology business goals;

Manage ad agency and other vendors in development of materials and tactics; Manage national conference planning and execution; Develop strong relationships with physician leaders and contribute to advisory board

planning; Develop and implement best-in-class speaker programs to support field sales efforts; Effectively interact with sales force and handle field requests; Provide input to development and implementation of annual product marketing plans; Manage allotted budget at or below plan while maximizing effectiveness of resources

and funds; Overnight travel as required (~25-30%). Qualifications: Minimum of 4 years of bio/pharmaceutical brand management including experience

working on projects that involved developing promotional materials and working with opinion leaders (required);

Two years successful experience in pharmaceutical sales (preferred); Strong ability to manage multiple projects simultaneously and work independently when

appropriate; Excellent leadership, teamwork, communication and relationship-building skills; Strong project management and communications skills; Bachelor’s degree (required). Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits. Questcor is an Equal Opportunity Employer. *************************************************************************

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Apply on company website Global Marketing Product Manager Medtronic - San Francisco Bay Area Posted 18 days ago


Job function Marketing


Industry Medical Devices

Job ID 6861617

Job description Position Description: Lead global downstream marketing efforts for key emerging therapy. Align commercial, training, messaging and other key efforts in order to deliver the potential of this breakthrough therapy and support the overall growth of one of the fastest growing business segments within Medtronic. Success will be defined by target therapy penetration and market share achievement. Additional responsibility to act as key commercial liaison between the business unit and assigned geographies. Will work with assigned geographies to create strategic plans, identify needs and opportunities in order to inform holistic investment strategies. Will also provide formal and informal leadership for projects spanning global and geography marketing teams as well as with cross-functional teams. Will keep close alignment with Upstream Marketing peers to ensure a well-planned product pipeline to ensure future portfolio success. Position will report directly to Director of Global Peripheral Marketing. Position Responsibilities: • Act as internal therapy expert on DEB and broad peripheral market. Leverage knowledge base to support customer meetings, cross-functional decision making and broad-based peripheral business strategy. • Lead creation / maintenance of DEB therapy positioning. Drive alignment within business, among KOL physicians and within identified physician segments. • Lead and organize global DEB product launches, aligning strategy and execution with geography and other cross-functional partners. • Own development of therapy-related messaging and strategies to drive belief and penetration within key identified physician segments. • Work with geography sales and global training leadership to determine sales force training needs. Lead content development for all technology / therapy related sales training programs. • Lead strategy and execution of key global peripheral conferences featuring DEB including LINC, CIRSE, VIVA etc. Support broad Cardiovascular conferences such as TCT, PCR, etc. • Cultivate key relationships with and regularly obtain feedback from customers and field organization to gather information, identify needs, and assess opportunities to help drive marketing programs. • Monitor sales trends and make recommendations for deeper penetration of DEB in the market. • Work with Upstream Marketing counterparts to identify portfolio / therapy line extension and future development options in order to protect leadership position within DEB segment. Basic Qualifications: Education: Bachelor of Science in Marketing, Business Administration or related field required. Masters in Business Administration preferred.

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Experience: • 7-10 Years with Bachelors; 5-8 Years with Masters; 3-6 Years with Doctorate; 0-3 Years with M.D., D.V.M. • Minimum 3-5 years marketing / sales experience within Peripheral Vascular Market or other associated vascular space • Experience leading product launches • Experience creating therapy position and developing cohesive brands and messaging • Global/International marketing experience strongly desired Technical Skills: Intermediate Microsoft Word, Excel and PowerPoint skills. Skills and Abilities: • Comfort working with, analyzing and communicating clinical data • Strong communication skills (interpersonal and presentation oriented) • Team-orientation and ability to build and maintain strong business relationships across functions • Enthusiasm and ability to drive alignment and rally teams to your vision • Analytical horsepower – ability to take disparate data points and weave clear conclusions / strategies Desired/Preferred Qualifications: Physical Job Requirements: Ability to travel up to 40% of the time. Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, Minnesota USA is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic's mission is: * To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. * To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions. * To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service. * To make a fair profit on current operations to meet our obligations, sustain our growth, and reach our goals. * To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. * To maintain good citizenship as a company. *********************************************************************** http://www.linkedin.com/jobs2/view/6918421?trk=rj_em Medical Science Liaison - Infectious Diseases (West) The Medical Affairs Company - SF, LAX, Pheonix or Seattle Posted 13 days ago Apply on company websiteSavedUnsaveSave


Job function Science


9/2/2013 11


Employer job ID TID-W-1

Job ID 6918421

Job description The Medical Affairs Company (TMAC) is recruiting for candidates in the West region possessing clinical experience within Infectious Diseases/Critical Care who have prior industry experience as a MSL. Qualified candidates will possess hospital/institutional based experience as well as a working knowledge of the managed care environment. The Medical Science Liaison (MSL) will represent our Client and its marketed product, a bactericidal injectable antibiotic, on a peer-to-peer level, engaging in clinically-based exchanges with national, regional and local Infectious Disease Key Opinion Leaders (KOLs) and treaters, and tertiary audiences including Managed Care Organizations (MCOs), Pharmacy and Therapeutics (P&T) Committees and Payers. The MSL will perform a variety of clinically focused activities ranging from developing corporate awareness of the Client Company to increasing awareness of the Product as an effective antibiotic for infections, including MRSA. The MSLs will be regionally deployed and aligned by districts that will be based on key institution/KOL presence. Build and strengthen professional relationships with institutional-based local, regional,

national KOLs, physicians and hospital infection control staff. Serve as a key clinical/scientific resource to these KOLs and institutions. Maintain thorough and up-to-date knowledge of disease state, clinical information and

product data within the Infectious Disease (ID) arena. Deliver clinical presentations to MCOs and accounts, optimally achieving formulary

status. Ascertain critical competitive intelligence through one-on-ones, group presentations and

attendance at medical meetings and appropriately communicate information back to senior management.

Support Clinical/R&D in the identification and facilitation of IISs/IITs and other research initiatives.

Support medical education initiatives such as Speaker Development, Advisory Board Support and serve as a resource to review materials for medical accuracy.

Provide technical support and training to field commercial and managed markets account teams once hired.

Desired Skills and Experience Advanced clinical/health science degree: PharmD, PhD, MD or equivalent; Board

Certification a plus Minimum two years clinical experience within infectious disease arena

(hospital/institutional-based preferred) Industry MSL experience required Managed care experience a plus Established track record of effective and influential oral presentations within the

healthcare profession Knowledge of FDA compliance and regulatory requirements Demonstrated expertise in drug information communication Ability to integrate and work in cross functional network Exceptional organizational and time management skills Excellent oral and written communication skills and interpersonal skills Ability to travel, locally and regionally combined, up to 70% (7-10 overnights per

month) Valid driver's license

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The Medical Affairs Company The Medical Affairs Company (TMAC) offers pharmaceutical, biopharmaceutical and medical device clients a complete array of outsourcing capabilities for medical affairs activities. Through strategic and tactical Medical Science Liaison (MSL) programs, as well as MSL Consulting and Medical Communications support, TMAC provides both unmatched value and service to the pharmaceutical industry. Our greatest strength is our focus: Medical and Scientific Affairs—it is our only business. Whether you have products in development or already on the market, we can help you optimize product awareness and understanding through customized MSL and Medical Communications solutions. TMAC's success is predicated on the fact that the entire management team has significant Medical Affairs expertise and has been actively engaged in the contract medical affairs sector since 1997. ************************************************************************** http://www.linkedin.com/jobs2/view/6764316?trk=rj_em Product Manager Amnis-Guava Systems EMD - Hayward, US-CA Posted 25 days ago


Job function Marketing, Product Management




Job ID 6764316

Job description EMD Millipore is seeking a Product Manager to drive centralized support and management of a strategic collection of product lines within the Cell Analysis product portfolio. Product families include lines of flow cytometers, data acquisition and analysis software, and an array of reagents and kits that are used in cell analysis for life science research. Strong communication and coordination of multiple initiatives is vital to the successful achievement of commercial objectives for this position. ESSENTIAL JOB FUNCTIONS: Support the Franchise Leader and Cell Analysis portfolio by taking responsibility for

product supply and general product needs through coordination with applicable functions within Millipore including Sales, Technical Support, Planning, Customer Service, Marketing Communication, Manufacturing, Global Supply Chain and Quality

Manage documentation process related to customer inquiries and notifications, new product part codes, production of marketing collateral and sales support materials.

Interpret R&D/performance data and help generate market information to drive technical content of catalogs, datasheets, brochures, direct-marketing efforts, and sales support tools.

Resolve issues involving packaging, manufacturing, and service with the assistance of the Product Manager.

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Respond to field questions and customer inquiries regarding technical specifications and quality issues by working with the appropriate people within the Millipore organization to make sure the response is delivered to the customer in timely manner.

Develop and maintain a working knowledge of factors affecting the product lines, collecting information and characterizing competitive threats to the business.

Visit customers through sales calls/trade show and conference attendance to understand market dynamics and gather data to support decisions involving product lifecycle management. Seek feedback regarding product needs and/or improvements from field sales.

Visit manufacturing sites to better drive efficiencies and solve commercial issues through understanding and relationship building with the local leadership of the sites.

Experience in a life science research laboratory is required. Experience in research and development for capital equipment products in a Life Sciences company is preferred. This position is responsible for one of the larger commercial areas within the Cell Analysis business so specific technical and/or marketing experience in the area of Flow Cytometry, Imaging, and Immunology is highly desirable.

Strong interpersonal and analytical skills. This position will have frequent interaction among several product managers and business owners including cross-functional departments including Research and Development, Business Development, Sales, and Manufacturing through the course of product development and product life cycle management. Desired Skills and Experience Bachelors degree in a biological or technically based science program or in lieu of a degree a minimum of four (4) years progressively responsible related experience in a technical role within a Life Sciences company. Experience in research and development for capital equipment products in a Life Sciences company is preferred. Minimum of 1-2 years experience in a commercial sales/marketing or technical services

role. Demonstrated experience in product management in life science, diagnostics, medical or similar environment is preferred.

Demonstrated understanding of basic marketing concepts such as product life cycle and product positioning.

Demonstrated ability to understand, analyze, and interpret scientific and technical journals and basic business reports desired.

Demonstrated knowledge of personal computer software in a business environment. Microsoft Office preferred.

Excellent organizational skills and interpersonal skills, including the ability to successfully work with other internal and external customers.

Excellent verbal and written communication and presentation skills. Ability to create and present materials appropriate to the level of audience. Ability to communicate in a clear, concise manner.

Ability to travel domestically and/or internationally. Travel may be up to 20%. Ability to work to and meet deadlines in a fast paced and challenging environment. *************************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=7038870&trk=jobs_seeking_view_job&goback=%2Evjs_7096468_*2_*2_*2_false_*2_*2 Associate Director Clinical Operations Valesta Clinical Research Solutions - San Francisco Bay Area Job Description Associate Director Clinical Operations Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources. Responsible for oversight and strategic direction and

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implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company. Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams. Directs development of SOPs within department and participates in development of collaborative SOP development. May contribute to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents. Contributes to development of abstracts, presentations, and manuscripts. Manages study teams to ensure deployment of resources. Travels nationally and internationally. Desired Skills & Experience Extensive clinical experience is required. Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required. Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines. Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems. Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing are required. Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required. Experience managing cross-functional teams or work groups as well as direct reports. Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required. Experience with presentations before executive staff. . Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources is required. Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required. Demonstrated ability to manage budgets. Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers. Ability to initiate, and lead departmental or interdepartmental strategic initiatives. Typically requires a BS degree in Biological Sciences, health care, or relevant scientific discipline, clinical background and minimum 12 years relevant clinical experience in the pharmaceutical industry with a MS degree and minimum 10 years of relevant experience. An advanced degree is desirable. Company Description The Cambridge Group is now a part of On Assignment, Inc. (ASGN), a diversified professional staffing firm providing flexible and permanent staffing solutions in specialty areas, including Clinical Research, Laboratory/Scientific, Healthcare (including nurses and physicians), and Information Technology and Engineering. For more information on this acquisition visit www.onassignment.com. The Cambridge Group has enjoyed over 30 years of steady growth and serves a diverse clientele with specialty practice areas in Information Systems, Pharmaceuticals, and Physicians. The Cambridge Group is a member of the National Association of Personnel Recruiters, Connecticut Association of Personnel Recruiters, American Statistical Association, American Staffing Association, and the National Association of Physician Recruiters. Quality people are the core strength of The Cambridge Group. Our professional staff of 35, supported by our research and administrative department, brings a unique combination of experience and perspective to each client we serve. We stand out because of our concern for both our client organizations and our candidates. Our reputation is known and respected, and the stability of our staff is a major factor in our relationships with the clients who know us best. Valesta Clinical Research SolutionsAdditional Information Posted:August 27, 2013

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Type:Full-time Experience:Director Functions:Research Industries:Pharmaceuticals Job ID:7038870 *********************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6990683&trk=jobs_seeking_view_job&goback=%2Evjs_7096468_*2_*2_*2_false_*2_*2 Associate Director, Predictive Diagnostics Medivation- San Francisco Bay Area View full job listing Job Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Associate Director Predictive Diagnostics, reporting directly to the SVP New Projects. Medivation is looking to hire a scientist who can lead the discovery and development of predictive diagnostics across the New Projects Division. The post-holder will also be expected to work with the Xtandi clinical team to ensure that the scientific aspects of any predictive diagnostics programs are effectively executed. The post-holder will be primarily based in the laboratory facility in Mountain View, but will also have a permanent location in the MDVN offices in San Francisco and will be expected to travel to the offices in San Francisco when required. Essential Duties & Responsibilities but not limited to the following: Specifically, the post-holder will be expected to run a small, laboratory-based group of RAs and, in the long run, scientists who will:

Discover relevant predictive diagnostic markers which may be used for stratification of patients in exploratory phase clinical trials

Validate the assays for clinical use and, when necessary, run the assays on tissue samples collected from exploratory phase clinical trials

Supervise the successful transfer of technology to Companion Dx partners Where appropriate, represent the Predictive Dx group on New Project Teams

Core Competencies, Knowledge and Skill Requirements: Track record of scientific achievement Experience in successfully discovering and developing laboratory tests as candidate

predictive diagnostics, including laboratory-based discovery, sample handling and analysis and reporting

Experience in working with Companion Dx companies Experience of success in managing other technical staff Ability to behave as a team player within multi-disciplinary teams Leadership capabilities, particularly within teams and with subteams

Education: PhD degree or equivalent, preferably in cell biology or oncology

Company Description Medivation, Inc. (Nasdaq: MDVN) is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options for patients in need. Medivation blends a unique business model with an expert team to bring promising medical technologies to patients. Medivation is made up of a vibrant, energized group of employees that are proud to be working for an innovative biopharmaceutical company. Medivation’s shared culture is evident through the trust and passion that employees exhibit. Medivation has created a unique

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community where employees are committed to making a difference in the lives of patients. Medivation launched its first approved product in September 2012. Medivation is a rapidly growing company with 300+ employees, located in beautiful San Francisco. Additional Information Posted:August 24, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Pharmaceuticals Job ID:6990683 *********************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=7096468&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=1ssg2Il52TslU1 Associate Director InVentivHealth Clinical- South San Francisco, CA (San Francisco Bay Area) Job Description Temp Clinical Scientist (Data Cleaner) Temporary Assignment -- Temporary Clinical Scientist SUMMARY: • Perform activities related to interim analysis and data base lock e.g. data cleaning clinical data review • Analyze and interpret study data and support preparation of reports for the FDA. Proactively provide feedback on emerging clinical and competitive trends. EDUCATION: • MS/MA degree in related discipline and seven years of related experience; or, • R.N., Pharm.D., PhD or M.D. in related discipline and five or more years of related experience, or; • Equivalent combination of education and experience. POSITION REQUIREMENTS: • Ten plus years Pharmaceutical experience preferred. • Extensive experience cleaning data • Experience with preparing clinical study reports preferred • Prostate Cancer experience preferred but not mandatory • Thorough understanding of clinical trial design, in Oncology preferred and all aspects of the drug development process is essential • Experience in activities related to interim analysis and data base lock e.g. data cleaning / clinical data review • Experience with EDC systems (e.g., InForm preferred) • Demonstrate thorough understanding of both clinical and commercial strategies and priorities. Desired Skills & Experience This is a 1 Year renewable contract position Additional Information Posted:August 30, 2013 Type:Contract Experience:Director Functions:Other Industries:Pharmaceuticals, Biotechnology

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Job ID:7096468 ************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=691E702D-F5AA-486A-ACD8-BA33ED79E6FC&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Job Summary Date Posted: 8/29/13 Location: Foster City, CA Business Conduct Attorney Gilead Sciences, Inc Job Description This function will best be served by an individual with experience working as a product attorney in the area of compliance with pharmaceutical promotional laws and regulations. Other candidates with litigation experience representing pharmaceutical companies on promotional issues are also considered. Working within the Business Conduct team, serve as a strategic partner to the commercial business to ensure appropriate and compliant promotional practices under applicable FDA and other statutory and regulatory requirements. Under appropriate supervision and in collaboration with colleagues on the Business Conduct and Commercial Legal Affairs teams, take substantial responsibility for reviewing and monitoring promotional materials and activities, as well as business strategies, associated with one of the company's discrete therapeutic areas. Contribute to the periodic review, revision and supplementation of corporate and commercial compliance policies and procedures to ensure they appropriately reflect legal and regulatory developments. Serve as legal compliance resource for company commercial activities including devising policies and procedures, training and monitoring processes to improve sales and marketing compliance. Appropriately triage a heavy workflow, setting appropriate priorities with clients and delivering results within the reasonable agreed timelines. Demonstrate ability to think creatively and devise solutions to challenging problems. Advance a positive spirit of partnership and collaboration with internal clients, internal legal colleagues and outside counsel. Exercise mature and reliable judgment while enjoying the company's enthusiastic, informal and fast-paced environment • Must have in depth skills and expertise within Business Conduct or policy creation, training and auditing. • Must have excellent written and verbal communications skills. • Must have strong client service orientation. • A Juris Doctorate from a nationally recognized law school. • 8+ years prior industry experience in a sales or marketing role, or 6+ years prior in-house or law firm experience providing legal counsel on the laws and regulations relating to drugs, devices, or food products demonstrating growth and ability to succeed. ***************************************************************************

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https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Job Summary Date Posted: 8/9/13 Location: San Jose, CA Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. · Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives. · Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives. · Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities. · Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

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· May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements. ********************************************************************** Send CV to: [email protected] MEDICAL DIRECTOR-CALIFORNIA BIOTECH US trained MD Oncologist OR Rheumatologist/Immunologist with or without industry experience needed for clinical development. Full relocation assistance including current home purchase, 18 month temporary living and help with new home purchase. Full details upon CV review. TRANSPACIFIC GROUP, INC. EXECUTIVE SEARCH Over three decades of placing MDs within the biopharma industry *********************************************************************** Send email (resume as attachment) at [email protected]. Senior UX Designer - Dublin, CA See details below. Other opportunities are posted in JOBS category at http://bit.ly/185vJ4V or in JOBS category at www.darshanavnadkarni.wordpress.com. Send email (resume as attachment) at [email protected]. Senior UX Designer - Dublin, CA There is an immediate opening for Senior UX Designer to join an organization dedicated to leveraging digital technologies to drive revenue growth and customer value for company’s software businesses. Working with a team of other user experience professionals, this position will be responsible for driving the design or redesign of individual products or product portfolios, to help define design signature of the company, create unrivaled design solutions, and communicate those design ideas in a way that is appropriate for the various stakeholders.

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Job includes working with some of the best external digital agencies along with world-class UX and technology leaders internally as part of a core member of a dynamic, exciting, fast-paced, and global team. Responsibilities also include: Act as a senior member of the Healthcare UX Center of Excellence; Participate in all aspects of UX – research, ideation, strategy, interaction design and visual design; Define and advocate multi-year roadmaps for UX engagement within products; Communicate roadmap and opportunities through the creation of “lighthouse” projects; Define internal standards for UX activities, and lead process improvement projects or initiatives; Proactively provide guidance to team members & management based upon awareness of UX strategy and program engagements; Use your knowledge of UX project planning & execution to lead project teams to the launch of successful software products with unrivaled user experiences; Be a subject matter expert in the area of interaction design, visual design or both. Be an evangelist for current trends in visual and interaction design for mobile, tablet, desktop and hardware-embedded software solutions; Act as a thought leader for high quality software development through the focus of UX; Multitask and manage the design of a product or product line in a cross-functional environment; Conduct design reviews with product UX teams and/or external resources; Build relationships with company’s businesses to develop and champion differentiating interaction design concepts; Coach and mentor team members. Required Skills & Experience: Bachelors in Graphic/Visual Design, Fine Arts, Library and Information Science, Human Computer Interaction, Marketing, Industrial Design, or a related discipline; 10+ years experience using Adobe platforms: Fireworks, Photoshop, Illustrator, InDesign and others; 5+ years consulting experience solving UX challenges in consumer & enterprise application environments; 5+ years experience & strong knowledge of site design; mastery in principles of Web & application design (HTML, XHTML, CSS, JS); Ability to travel domestically & internationally up to 20%, including overnight stays. No telecommuting. Location: Dublin, California Desired Qualifications: 10+ years experience & knowledge of goal-directed principles, processes & methodologies; Portfolio demonstrating successful examples of conceptual designs, prototypes, & final design patterns used in commercialized products; A track record that demonstrates significant knowledge & experience in strategy, ideation & product definition using disruptive design practices; A demonstrated understanding of all phases of goal-directed design & development, and the ability to create unrivaled interfaces that solve hard problems with elegant interaction solutions. ************************************************************************** For the opportunity below, please send resume to [email protected]. Other opportunities are posted at the link below. R&D Technician - San Jose, CA There is a steady pickup in Life Science Job Market. I have lots of jobs posted. There is an immediate opening for a Medical Device Senior Technician in an early stage company, located in San Jose, CA, developing a novel approach for the oral delivery of large molecules. Responsibilities: Perform experimental device component fabrication, device assembly; device testing and analysis, maintenance and troubleshooting on manufacturing equipment and process, Develop fixtures for testing or manufacturing, and Compile data on device testing. Requirements: 5+ years work experience in an industrial or laboratory environment; experience in medical device or

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pharmaceutical operation, with test equipment including instron, burst, weight, pressure, and force test equipment and with basic chemistry laboratory processes including measuring, mixing solutions, chemical storage, and laboratory safety. Also required: Demonstrated mechanical skills, Ability to read and follow written instructions, Ability to interpret engineering drawings, Familiarity with plastic manufacturing processes including molding, forming, and bonding, Familiarity with principles of machine operation, machine control systems, pneumatics, and motors, Computer skills including Word, Excel, Outlook, Ability to operate independently and function as a team member, Good written and verbal communications skills., Familiarity with principles of GMP and/or GLP operations. ********************************************************************** Posted by Nancy Symonds, President, NJS Recruiting Services http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=269657853&gid=48201&trk=eml-anet_dig-b_jb-ttl-cn&fromEmail=&ut=12M1YdMGipqlU1 ASSOC. DIRECTOR, CMC REGULATORY AFFAIRS - SAN FRANCISCO BAY AREA We have an immediate need for two open positions - one requires biologics and the other small molecule. 6+ years experience in a regulatory affairs department involved with CMC filings is also required. Please send your resume to [email protected]. Please let your colleagues in CMC Reg Affs know about these opportunities. Relo assistance is available. As always, thanks for your referrals! ********************************************************************** http://qmedcareercentral.devicespace.com/jobs/job-listing/software-process-engineer-321016?type=email&source=DS_082613 Software Process Engieer-Natera Job Description Software Process Engineer Natera’s mission is to give couples the best chance of having a healthy child and we need your help to bring the latest technology in genetics together with advanced signal processing and statistics. The Software Process Engineer within the Process Engineering Group contributes to the development and implementation of automation systems and workflows to support the processing of samples in a clinical diagnostics laboratory environment. This individual collaborates within a team of scientists and engineers upon projects to conceptualize, design, develop, and implement software tools designed to run and manage the flow of samples throughout the automated systems and optimize the performance of the laboratory and samples processing prior to sequencing. Principal responsibilities include: Primarily responsible for creating software tools to integrate and run robotic systems and samples workflows in the labs. Coordination and collaboration with cross functional teams involved with these automation efforts; including LIMS, Software, and Bio-informatics groups. Incorporate user and workflow requirements into machine UI, and collaborating with others involved in implementing the deploying these solutions. Secondary responsibilities include: Building and maintaining rapport with end-users and process owners. Contributions to system software development and hardware integration. Documentation for equipment validation and operating procedures, and ensure successful implementation in the labs. User training, troubleshooting, optimizing the automated systems, and on-going support for the end-users. Requirements BS or MS degree in Software Engineering, Bio-medical engineering, or related fields with emphasis on programming; and a minimum of eight years of relevant experience. Technical proficiency and experience with the following tools: C# and VB.Net, Java programming, WPF, Winforms, XML, SQL, UNIX and Windows Programming, COM and .Net inter-operation programming.

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Solid background in Windows client software development, Software Integration of complex systems composed of several instruments, including developing run managers, User Interfaces, drivers, and communication tools necessary for the integration and operation of these systems. Experience preparing User Requirements, Testing Procedures, Standard Operating Procedures, and related documentation. Biotech, pharmaceutical, Lab automation providers experience is highly desirable. Project management skills, organizational skills, and written and verbal communication skills are required. Flexibility and self-initiative required to support several simultaneous projects in a collaborative environment. About Natera Natera is a genetic testing company that has developed a proprietary bioinformatics-based technology (NATUS) to deliver accurate and comprehensive high-throughput testing for reproductive indications from tiny quantities of DNA. Natera operates a CLIA-certified laboratory in San Carlos, Calif., providing a host of preconception and prenatal genetic testing services. Natera's PreNATUS clinical trial for non-invasive screening of fetal chromosomal anomalies is funded by the NIH and is being conducted by the leaders in maternal-fetal medicine in the United States. On May 1st Natera has completed a $54.6 million financing round to support the expansion and continued global rollout of Natera’s non-invasive prenatal test, Panorama™. The financing round included two new lead investors, OrbiMed Advisors and Harmony Partners, as well as other undisclosed new investors. All existing investors participated, including Claremont Creek Ventures, Lightspeed Venture Partners, Founders Fund and Sequoia Capita ************************************************************************** Darshana Varia Nadkarni, Ph.D. Medical Device/ Biotech Recruitment Cell: 408 898 0000 I have lots of jobs and more are coming. Can you list the following one line in all your postings? There are opportunities listed in JOBS category at www.darshanavnadkarni.wordpress.com and you can send resumes to [email protected]. Current Jobs include

General Manager of Software Engineering - N. CA for large $19B total revenue company & requires broad strategy experience.

Territory Sales Manager with Medical Injection Molding Experience - Santa Cruz, CA Program Manager with Medical Injection Molding Experience - Santa Cruz, CA R&D Technician - San Jose, CA Tooling Engineer with Medical Injection Molding Experience - Santa Cruz, CA Senior Quality Engineer - San Jose, CA Manufacturing Manager - South Bay (requires medical injection molding experience)

*************************************************************************** Ronald H. Coelyn 817-424-3652 [email protected] Our Firm is currently working on several executive search projects for LifeScience industry clients. We would value your help in identifying some exceptional candidates for one of them in particular. The Company is a privately held, medical device/biotechnology (combination products) company developing targeted therapeutics for the treatment of certain diseases using a proprietary, medical device disruptive technology. As the Company's technology is highly confidential nothing more can be provided about it at this time.

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Chief Commercialization Officer Reporting to the President & Chief Executive Officer, the Chief Commercial Officer will be a leading member of the Senior Management Operating Committee working in conjunction with key strategic partners. He/she will be highly respected, visionary leader in his/her industry sector, with a demonstrated track record of success in building businesses through hands-on interaction with his/her teams. Product commercialization, strategic marketplace positioning, sales force management, business development and highly effective profit and loss ("P&L") management (including the generation of positive cash flow) should have been cornerstones of prior accomplishments. We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals ************************************************************************* Contact Chip Gray 412-531-1200

Territory Mechanical Sales Engineer in SF area to sell precision fluidics devices and solutions in the North West Territory

I'm searching for Territory Mechanical Sales Engineer in SF area to sell precision fluidics devices and solutions in the North West Territory. Responsible to maintain, develop, and cultivate professional, strategic relationships with Engineering, R&D, and Procurement departments at OEMs while executing the Division Growth Strategy Deployment. Target Markets include Clinical Diagnostics, Respiratory and Anesthesia, Patient therapy, Molecular Analysis and Separations, and Agent Detection. Looking for a rising star couple years OEM sales experience.

*************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. · Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.

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· Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives. · Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities. · Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. · May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements. **************************************************************************

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http://www.linkedin.com/jobs2/view/6800533?trk=rj_em Director, Business Development for API Development and Manufacturing WuXi AppTec - Work from Home Posted 13 days ago

Experience Director

Job function Sales



Job ID 6800533

Other Details About this job

Job description This position is responsible for leading the business development activities in the US west coast within STA, WuXi’s API development and manufacturing division. The position works closely with STA’s other BD team members and senior management team in China to develop and execute the most effective strategy to increase API and intermediate sales in their area of geographic responsibility. This position manages sites for key accounts and is also responsible for business development for any new accounts. This position works proactively with other BU team members, such as other BD team members, Marketing, Project Management, Technical Groups and Operations to assure objectives and goals are achieved. This is a work from home position - we prefer that the candidate reside in San Francisco, CA or San Diego, CA Develop plans and programs for existing accounts in his/her geography to gain market

share in existing businesses, cross sell process development and manufacturing services and increase site penetration of all key accounts.

Develop strategies and tactics to gain new business. Achieve sales revenue targets for key accounts and new accounts. Record progress of BD activities and provide regular updates to management. Work closely with business units, project management team and marketing to ensure

coordination of efforts and ensure good communication with all parties. Help set up BU visits and stay involved when customers visit China.

Collects and utilizes various data sources provide competitive intelligence, tracking and analysis of the competitive landscape in assigned segment.

Desired Skills and Experience BA/BS in Life Science (preferably in Chemistry related field),Business, Marketing

or related Technical degree, or equivalent training and/or experience is required. Master’s in Business Administration (MBA) or Masters (MS) in Life Sciences is

preferred. 5-10 years of relevant industry experience in chemical or pharmaceutical

development and/or manufacturing. Experience in CRO, CMO or API development and manufacturing organization is preferred.

5+ years of sales, project management and/or business development experience. Must have a proven track record of success meeting or exceeded goals/targets. Experience successfully navigating large matrixes organizations. Experience developing new accounts through various prospecting tactics.

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Experience selling products/services that typically require longer sales cycles (9 – 24 months). Strong knowledge of selling skills and selling strategies. Proven ability to meet or exceed company annual sales goals.

Must be a self starter, self-motivated, highly flexible, with excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.

Proven experience in creating successful business development plans and processes. Marketing experience preferred but not required.

Excellent communication skills both in verbal and in writing. Must be willing to travel a minimum of 50% of the time on an annualized basis

within and outside of assigned geographic region. About this company WuXi AppTec Following companyUnfollow companyFollow company WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device outsourcing company with operations in China and the United States. Shanghai Syn-The-All Pharmaceutical Co. Ltd. (“STA”) is a wholly owned subsidiary of WuXi AppTec. STA provides an open access platform with “end-to-end” small molecule API/intermediate development and manufacturing capabilities from preclinical to commercial stages. STA is the global leader in chemical process research and development including synthetic route development, process development and optimization, and process scale up and is capable of producing APIs and intermediates from grams to hundreds of metric ton scale. *************************************************************************** Apply on company website Director of Product Marketing SK Planet, Inc. - San Francisco Bay Area Posted 12 days ago Apply on company websiteSavedUnsaveSave

Experience Director



Industry Computer Software

Job ID 6734872


Job description The Director of Product Marketing will be responsible for 1) driving market assessment for new product ideas and providing feedback to product development teams, 2) leading the development and execution of customer acquisition and customer retention strategies, 3) determining budget requirements, and 4) managing the overall efforts to build a sustainable user base, maximize revenues, and generate positive brand recognition. You will combine leading edge marketing practices and a data-driven approach as well as think out of the box in order to accomplish goals, and you will provide leadership and guidance to marketing managers assigned to specific products. This is an ideal role for a senior marketing professional skilled in product marketing in the mobile space. Desired Skills and Experience Responsibilities:

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Lead a product marketing team to develop and execute the customer acquisition, retention, and monetization plans aimed at achieving specific business targets;

Assist in hiring product marketing managers and oversee execution of marketing plans; Perform market and user research and provide planning support to product teams; Provide insight on value propositions, messaging, business models and

features/functionality of competitors; Guide product teams in crafting core product marketing messages based on key

features/functionality; Work with product teams to develop revenue models and determine product pricing; Design and produce a full range of mobile, online and social advertising initiatives; Oversee the development of launch strategies and marketing programs that will drive

demand; Direct product teams in establishing, implementing, and monitoring customer

engagement plans; Work with product teams to incorporate user feedback into new product releases Identify and track key performance metrics to maximize effectiveness of marketing

programs; Work with the analytics team to further understand product usage and customer

behavior and adapt marketing strategies as necessary; Evangelize the disruptive value of our mobile products and ensure a consistent, unified

message across all products . Required Skills / Experience: 10+ years of marketing experience in consumer internet and mobile products Experience in owning product marketing responsibilities and launching multiple mobile

apps via app stores and app discovery sites Experience with marketing apps designed for both Android, and iOS devices Deep knowledge of leading edge online and mobile marketing tools; Demonstrated ability to set strategy as well as work hands on to drive implementation; Solid understanding of app monetization strategies, mobile advertising campaigns,

social media based marketing, and tools for promoting viral growth; Ability to work with minimal guidance and to manage a team; Ability to communicate effectively with a broad spectrum of colleagues and external

partners; Must be creative, flexible, highly organized, and comfortable in a rapidly evolving

environment; Experience in data-drive performance analysis; Understanding of both web-based and mobile businesses; Strong quantitative and analytical skills; Ability to manage corporate level marketing communications and PR activities a plus. Education: Bachelor’s Degree required; MBA preferred.

About this company SK Planet, Inc. Following companyUnfollow companyFollow company About SK Planet, Inc.: SK Planet is a globally recognized and respected leader in innovative mobile solutions. As part of the 3rd largest conglomerate in Korea, we operate many of the country’s most successful businesses, including the leading online music service (Hoppin), the largest app store (T-Store), and the most popular virtual shopping service (11 St). We are now looking to achieve success beyond the Korean market by leveraging our considerable assets and expertise to establish a significant US presence. Our first step has

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been to set up a dynamic new company in San Francisco unlike typical venture-backed startups in the valley that are encumbered with uncertain funding and limited in their scope of activities. With the committed, long-term support of a billion dollar plus parent company, our “startup” is armed with the resources needed to pursue multiple product categories and to develop robust solutions to “big problems.” Our goal is to create new mobile content ecosystems starting with two key market segments - video and education - where we have identified opportunities to further define how digital content is delivered, consumed and monetized. With video, we are planning to build a platform that connects creators and curators of high-quality short-form content with targeted advertisers in order to maximize their value while providing compelling experiences to consumers. For education, we are designing an adaptive learning system initially focused on improving students’ performance in K-12 mathematics and sciences but designed to eventually serve as an intelligent distribution platform for educational content across multiple subject areas. In addition to these initiatives, we have also assembled a proven team of mobile game developers who are now designing leading edge products in interactive entertainment. Our mission is to transform content creation, distribution, consumption, and monetization in the fastest growing communications industry in history. Join us and help build the next generation of great mobile products. Working at SK Planet, Inc.: Our US operations are still in start-up mode but growing rapidly. We have an open and collaborative office based in San Francisco’s SOMA district, just 2 blocks from both the CalTrain and AT&T Park. We promote a very open and entrepreneurial environment that allows for new ideas and great motivation. Benefits and Perks: We are an Equal Opportunity Employer and offer a comprehensive benefits package

including but not limited to: Medical, Dental & Vision (100% Company paid) Life and AD&D Insurance Short and Long-Term Disability Insurance Commuter Check Flexible Spending Account 401(k) + company match Generous Vacation Pay + Sick Pay + Holiday’s Tuition Reimbursement Program And many more to come as we grow our team! ************************************************************************** http://www.linkedin.com/jobs2/view/6877042?trk=rj_em Product Marketing Director Rodan + Fields Dermatologists - San Francisco Posted 9 days ago

Experience Director



Industry Health, Wellness and Fitness

Job ID

9/2/2013 29

6877042 Other Details

About this job Job description Rodan + Fields is seeking a Product Marketing Director to strategically drive and execute the company’s product management activities. This position will report to the CMO and work with Research and Development, Operations, Finance and Field Development. Primary Responsibilities Drive Product Leadership Platform Lead development of a set of principles, standards and best practices which will position

R+F as the global leader in anti-aging skincare. Principles and standards to include: Development of 3 yr category strategy to include

product pipeline and marketing strategies. Develop/support global expansion plan into new markets.

Creation of category goals, objectives, strategies and metrics that measure progress/success.

Development and management of product marketing calendar. Management of products from concept to market launch, Ability to develop product concepts as a deliverable of the 3 yr category pipeline. Ability to work with Research and Development talent to deliver unique product

concepts. Drive Customer Adoption Allocate Product Marketing resources Collaborate with cross functional team, including R&D, Operations, Field Development

and Finance, to resolve product related challenges and issues Lead development of all product marketing tools Provide feedback on content, piloting and implementation of product marketing activity Understand/synthesize Shopper Insights, Business Intelligence and New Product

Innovation tools to understand the category and its competitive set. Measure and Improve: Assess product and program performance and Identify opportunities for improvement Work with Field Development, Finance and Business Intelligence to track effectiveness

of all product marketing initiatives People Management: Successfully build and lead a team of Skincare Innovation Professionals Guide activity of direct reports Provide performance feedback and development plans to direct reports Desired Skills and Experience Critical Skills: Portfolio & Brand Understanding a must Diversity in marketing channel experience preferred Channel, Shopper & Market Understanding Route to Market Profitability Financial and Business Acumen Strategic Business Planning and Development Training Knowledge Background & Experience: 8-10 years experience in category management in major CPG categories Experience building, leading and mentoring effective teams Experience building retail marketing/selling tools required Familiarity with leading space management and data aggregation applications Experience working with multi-channel distribution model preferred Exposure to product innovation development and implementation required

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CPG and retail experience is important but innovative approaches are critical and candidates who have track record of launching innovation into the marketplace highly desired for this pivotal role.

Beauty/Skincare Category experience preferred Must be willing to travel Post graduate degree preferred Undergraduate Degree Required

About this company Rodan + Fields Dermatologists Following companyUnfollow companyFollow company About Rodan + Fields We help people live better in their skin. Rodan + Fields, the direct selling company, was launched in 2008 by founders, Dr. Katie Rodan and Dr. Kathy Fields, the creators and licensors of the wildly successful direct marketing phenomenon, Proactiv Solution. The Rodan + Fields brand was first introduced into the market in 2002 via the prestige department store channel. Although recognized as a top clinical brand in leading stores, the company ultimately concluded that the department store environment was a constraint to the growth potential of the brand and, in 2007, implemented a business transformation strategy that included acquisition of the business from Estee Lauder, withdrawal from department store distribution, and a re-launch of the business under a new direct selling platform. Since the re-launch of Rodan & Fields, LLC as a network marketing company in March, 2008, the company has realized consistent triple digit annual growth and was recognized by the Direct Selling Association as the Rising Star in 2010 and won the 2013 American Business Award for best consumer products company. Today, our products reach tens of thousands of consumers through a network of micro-entrepreneurs who are seeking to take their share of the lucrative $3.0 Billion anti-aging skincare market as they leverage the Rodan + Fields brand, business model and innovative web, mobile and social technology. *********************************************************************** http://www.linkedin.com/jobs2/view/6693381?trk=rj_em Posted by Fan Herbst Director of Human Resources Director, Marketing (Lead US Product Launch) Nevro Corp. - San Francisco Bay Area Posted 23 days ago




Industry Medical Devices

Job ID 6693381this job

Job description Title: Director, Marketing (Lead US Product Launch- Medical Device Expertise) Department: Marketing JOB SUMMARY

9/2/2013 31

This important marketing management role is responsible mainly for the US expansion of Nevro’s products. In addition, key member for providing ongoing leadership, vision and support to the commercial marketing organization to assure attainment of business objectives including timely product launches, sales support and direct marketing to consumers and clinicians. This position reports to the Chief Business Officer. ESSENTIAL DUTIES & RESPONSIBILITIES (includes the below tasks, but not limited to the following): Lead downstream execution for OUS (and US when we get closer to US launch). Work closely with the upstream product marketing team to ensure a smooth transition

from product development to robust commercialization. Provide input and support for customer needs assessments to be used as inputs to product marketing.

Develop plans and take a leadership role for Marketing Communication, Commercial Marketing (including Digital/Social Media) for organization. Work with senior leadership to develop and manage the marketing communication plan (internal and external). Create and execute successful media campaigns.

Create and deliver high impact promotional marketing material (to include brochures, website, case studies, etc.) that drive to company objectives.

Develop updated positioning strategies and messaging. Ensure all external communication is on point with messaging and brand. Drive and ensure consistent brand messaging throughout all communications.

Lead tradeshows, medical meetings and events. Responsible for all aspects from creative, brand, messaging to logistics and onsite management.

Work closely with the upstream product marketing in development of materials and provide ongoing leadership and support of sales training programs.

Work closely with Sales leadership to develop and implement sales tools that will support the business goals. Develop and manage global forecasts with sales leadership.

Develop, implement and measure marketing campaigns to include, online and print advertising, media planning, CRM initiatives, and patient awareness and education materials, website/microsite development.

Work closely with field sales to identify opportunities and ensure effective execution of marketing plans and tools.

Other duties as assigned. Desired Skills and Experience EXPERIENCE 10 to 15 years of post-MBA experience in medical device marketing. Minimum of 5+ year’s commercial experience with at least 2 years leading a

product/brand team. Experience in leading new product launch campaigns in US and OUS. Experience in medical device/ diagnostics or biotech mandatory. Must have experience

developing strategies and in business planning. Strong analytical skills including user needs analysis, financial business modeling,

budgeting and forecasting required. SKILLS & KNOWLEDGE Downstream marketing experience. Strong team player who can incorporate input from others and can generate consensus

through inclusion. Must be able to thrive in a fast-paced and dynamic work environment. Ability to speak up when important information or questions must be raised and takes

action when issues must be addressed. Strong thinker and creative thinker who is intellectually curious. Sound decision making capabilities.

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Good organizational skills and ability to meet tight deadlines in an environment of competing priorities. Ability to routinely work on multiple tasks with multiple people while effectively prioritizing.

Ability to develop strong relationships with customers, clinical & sales partners. Excellent interpersonal, communication and negotiation skills for a wide variety of

audiences, including sales & marketing leadership. RESPONSIBILITY FOR PERSONNEL There are no direct reports under this position at this time. PHYSICAL DEMANDS This position requires driving and travelling to visit customers. In addition, the use of the telephone and keyboard on a daily basis. Carrying company equipment on trips will include laptops, chargers, brochures, as well as study related equipment, i.e. programmers, demo kits. WORKING CONDITIONS Hospitals, operating rooms, clinics, surgical centers. Domestic and international travel 30% to 40%, more travel needed up front. About this company Nevro Corp. Nevro Corp. was established with the vision of providing unprecedented pain relief to those suffering from low-back pain and other challenging types of chronic pain. Inspired by work conducted at the Mayo Clinic, Nevro was created to develop a novel high-frequency neurostimulation technology that aims to revolutionize the role of spinal cord stimulation in the treatment of chronic pain. • Founded in 2006, headquartered in Menlo Park, Calif. • Privately held, raised over $100M from leading life science investors • Senza™ High-Frequency Spinal Cord Stimulation System evaluated in hundreds of patients to date across numerous U.S., EU and Australia-based clinical studies • Received CE Mark approval in 2010 and Australian TGA approval in 2011 • Granted U.S. Food and Drug Administration approval for, and initiated, the randomized SENZA-RCT pivotal study in 2012 ************************************************************************ http://www.linkedin.com/jobs2/view/6876285?trk=job_view_similar_jobs Director of Clinical Operations ArmaGen Technologies - Greater Los Angeles Area Posted 9 days ago


Job function Science


Industry Biotechnology

Job ID 6876285

About this job Job description The Director of Clinical Operations will provide operational and implementation expertise to Clinical Development Team. The successful candidate will be a key interface with all contract research organizations (CROs) and clinical sites involved in the clinical trials. In addition, the Director of Clinical Operations will lead the clinical trials implementation team and have

9/2/2013 33

oversight of clinical trial CROs and laboratory vendors. The successful candidate will work extremely closely with the VP Clinical Affairs. Desired Skills and Experience Job Qualifications: Advanced degree (MS/PhD) with sciences major preferred, but will consider direct

relevant experience plus BA/BS in lieu of advanced degree. 10 or more years R & D experience in biotech, Pharmaceutical or relevant clinical CRO

experience. Experience in execution of CNS clinical trials and/or biologics preferred, including

experience in both small Phase 1 studies and larger, multi-center trial management Well versed in cGCP and applicable FDA/EMEA regulations required Ability to prepare and present clinical trial updates to senior management About this company ArmaGen Technologies ArmaGen® provides platform technology solutions to the blood-brain barrier (BBB) problem and can non-invasively target recombinant proteins, therapeutic monoclonal antibodies, and siRNA to the brain ************************************************************************** To apply: http://tinyurl.com/mym7ex6 Senior Medical Director, Clinical Science BioMarin - San Francisco Bay Area Posted 24 days ago


Job function Other



Employer job ID 13-0197

Job ID 6679545

About this job Job description BioMarin Pharmaceutical seeks a medically-trained clinical scientist with expertise in clinical research and drug development to join a multidisciplinary team involved in development of novel therapeutics for rare/orphan diseases. The candidate should be proficient in clinical study design, and execution and analysis of results. Experience interacting with clinical investigators, FDA and other regulatory authorities is highly desired. RESPONSIBILITIES 1. Hands-on participation in the clinical trial development process - conceive and execute clinical strategy and provide clinical expertise in all phases of development from pre-IND to Phase 4 2. Lead preparation of clinical sections of all relevant regulatory filings (BLA, EU Marketing application, IND, study reports, NDA, etc) 3. Participate in management of studies and serve as expert on clinical and medical issues to internal colleagues and study site staff 4. Take leadership role in review and analysis of study data and writing of study reports

9/2/2013 34

(CSRs) 5. Lead preparation of responses to regulatory agency queries (RTQ) and participate in FDA pre-marketing authorization meetings, EMA Scientific Advice meetings and other regulatory agency meetings 6. Attend and provide clinical/scientific support for investigator and consultant meetings 7. Assist in writing and preparing publications, abstracts and presentations 8. Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan 9. Serve as medical/scientific resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources 10. Interact in collaborations with strategic partners 11. Represent the company at scientific, commercial and financial community meetings and presentations 12. Serve as the Medical Monitor and Leader for clinical trials 13. Provide input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design 14. Contribute to planning and compliance with inspection readiness 15. Support business development activities, including due diligence activities 16. Interact with research/discovery to review and identify lead candidate molecules for Clinical Development To apply: http://tinyurl.com/mym7ex6 Desired Skills and Experience EDUCATION MD or MD/PhD Post-graduate training/experience essential (i.e., U.S. internship/residency, (board-eligible as a minimum), or fellowship,) EXPERIENCE 1. For appointment at the Senior Medical Director level a minimum of 7 years experience in the pharmaceutical/Biotech industry is required 2. For appointment at the Medical Director level; 5+ years experience in clinical functions in pharmaceutical or biotech industries. 4. Knowledgeable and current in GCP guidelines in US and Europe 5. Be well connected within the medical and scientific community and have a proven successful track record in management of clinical trials 6. Outstanding leadership, team, presentation, written and oral skills required 7. Collaborative and flexible in personal interactions at all levels of the company 8. Ability to work proactively and effectively, with exceptional creative problem solving skills 9. Works well with project teams and the respective functions, in particular Regulatory Affairs, Clinical Operations, Biometrics, but also Project Management, Research, Clinical Pharmacology and Commercial. 10. A strong interest in rare diseases that frequently requires creative thinking with regards to study design, endpoint selection or data analysis. 11. Experience in one or the following therapeutic areas would be considered advantageous: endocrinology, neurology, pediatrics, allergy/immunology About this company BioMarin BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation;

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Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. *************************************************************************** Apply on company website Product Manager Amnis-Guava Systems EMD - Hayward, US-CA Posted 17 days ago


Job function Marketing, Product Management




Job ID 6764316

About this job Job description EMD Millipore is seeking a Product Manager to drive centralized support and management of a strategic collection of product lines within the Cell Analysis product portfolio. Product families include lines of flow cytometers, data acquisition and analysis software, and an array of reagents and kits that are used in cell analysis for life science research. Strong communication and coordination of multiple initiatives is vital to the successful achievement of commercial objectives for this position. ESSENTIAL JOB FUNCTIONS: Support the Franchise Leader and Cell Analysis portfolio by taking responsibility for

product supply and general product needs through coordination with applicable functions within Millipore including Sales, Technical Support, Planning, Customer Service, Marketing Communication, Manufacturing, Global Supply Chain and Quality

Manage documentation process related to customer inquiries and notifications, new product part codes, production of marketing collateral and sales support materials.

Interpret R&D/performance data and help generate market information to drive technical content of catalogs, datasheets, brochures, direct-marketing efforts, and sales support tools.

Resolve issues involving packaging, manufacturing, and service with the assistance of the Product Manager.

Respond to field questions and customer inquiries regarding technical specifications and quality issues by working with the appropriate people within the Millipore organization to make sure the response is delivered to the customer in timely manner.

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Develop and maintain a working knowledge of factors affecting the product lines, collecting information and characterizing competitive threats to the business.

Visit customers through sales calls/trade show and conference attendance to understand market dynamics and gather data to support decisions involving product lifecycle management. Seek feedback regarding product needs and/or improvements from field sales.

Visit manufacturing sites to better drive efficiencies and solve commercial issues through understanding and relationship building with the local leadership of the sites.

Experience in a life science research laboratory is required. Experience in research and development for capital equipment products in a Life Sciences company is preferred. This position is responsible for one of the larger commercial areas within the Cell Analysis business so specific technical and/or marketing experience in the area of Flow Cytometry, Imaging, and Immunology is highly desirable.

Strong interpersonal and analytical skills. This position will have frequent interaction among several product managers and business owners including cross-functional departments including Research and Development, Business Development, Sales, and Manufacturing through the course of product development and product life cycle management. Desired Skills and Experience Bachelors degree in a biological or technically based science program or in lieu of a degree a minimum of four (4) years progressively responsible related experience in a technical role within a Life Sciences company. Experience in research and development for capital equipment products in a Life Sciences company is preferred. Minimum of 1-2 years experience in a commercial sales/marketing or technical services

role. Demonstrated experience in product management in life science, diagnostics, medical or similar environment is preferred.

Demonstrated understanding of basic marketing concepts such as product life cycle and product positioning.

Demonstrated ability to understand, analyze, and interpret scientific and technical journals and basic business reports desired.

Demonstrated knowledge of personal computer software in a business environment. Microsoft Office preferred.

Excellent organizational skills and interpersonal skills, including the ability to successfully work with other internal and external customers.

Excellent verbal and written communication and presentation skills. Ability to create and present materials appropriate to the level of audience. Ability to communicate in a clear, concise manner.

Ability to travel domestically and/or internationally. Travel may be up to 20%. Ability to work to and meet deadlines in a fast paced and challenging environment. ************************************************************************** http://www.linkedin.com/jobs2/view/6806726?trk=rj_em Associate Director/Director, Business Development Bavarian Nordic A/S - San Francisco Bay Area Posted 13 days ago

Experience Director

Job function Business Development



9/2/2013 37

Job ID 6806726

About this job Job description With global headquarters in Denmark, Bavarian Nordic (CSE:BAVA) is a revenue-generating multi-national biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company focuses on developing product candidates to address cancer and infectious diseases by leveraging several core strengths: • Extensive R&D expertise in vaccines and immunotherapy • Broadly applicable platform technology • Multiple clinical stage development programs, including two Phase 3 trials • Flexible, commercial scale manufacturing facility • Significant financial resources resulting from its biodefense business (IMVAMUNE® supply contracts and government-funded R&D programs) Cancer Immunotherapy Division The company operates as Bavarian Nordic, Inc. in the US, and the Cancer Immunotherapy Division is based in Mountain View, California. The Division is committed to building a pipeline of immunotherapy candidates for major cancers with large unmet medical needs and features a leadership team with extensive expertise in drug development and commercialization, oncology, and urology. Analyst estimates have suggested that the commercial potential for cancer immunotherapies could be as high as $35B in 10 years’ time. The Division’s lead development candidate, PROSTVAC®, is already in a Phase 3 pivotal trial. A second product candidate, CV-301 is being evaluated for FDA Breakthrough Designation and a second Phase 3 program in colorectal cancer. BN is seeking a talented professional to join the Business Development team. Your job is to provide strong marketing and business input to the BN research programs, from discovery to market. You will ensure that BN pursues product opportunities that are directed at key unmet medical needs, fit within the company’s strategy and are commercially viable. You will assist with business development activities including in-licensing, out-licensing, mergers/acquisitions and alliance management. This will include considerable communication, work and collaboration across other functional areas. Responsibilities: Business Development: Support business development activities with key analytical and partner interaction

contributions Perform market/financial and valuation analysis in support of licensing activities Develop presentation materials and white papers Coordinate due diligence activities including meeting scheduling, and logistics,

interdepartmental involvement and company communication Assist in the preparation of term sheets and licensing agreements Support contract negotiations Attend partnering meetings and other industry conferences Assist in performance of alliance management activities

Lead efforts to help drive the commercial assessment of, and input to, internal research programs as well as potential licensing and/or M&A activities.

Portfolio Management: Assist in the portfolio assessment process across all of research incorporating measures

of science, development, finance and business inputs Develop economic and market positioning aspects of the portfolio assessment Develop and implement effective portfolio decision analysis approaches

Implement portfolio competitive intelligence gathering and review process.

9/2/2013 38

Proactively identify and bring forward new ideas to the R&D team for optimizing the portfolio and viewing external market benchmarks for insight to different approaches in the R&D process.

Desired Skills and Experience Qualifications: Requires a bachelor’s degree in Marketing, Business Administration, Life Sciences or

equivalent; postgraduate science degree and MBA preferred. 8+ years of experience in the biopharmaceutical industry; 3-5 years in business

development preferred, particularly in oncology therapeutic areas. Experience working on cross-functional project teams, including leading teams to

measurable outcomes. Must possess strong analytical, quantitative and communication skills and demonstrated

experience in strategic planning. Must have high level of proficiency in Excel, Word, and PowerPoint. Thorough knowledge of the pharmaceutical industry, including experience in and

understanding of drug discovery and development. Expertise in decision analysis and portfolio management techniques. In-depth knowledge of healthcare markets and the oncology therapy area. Strong leadership, interpersonal and influencing skills including the ability to operate

effectively in a team setting and to interact with a wide range of people across functional and seniority boundaries.

Excellent verbal, written, financial analysis and presentation skills required. Experience in financial analysis and modeling including risk-adjusted project valuation,

strong strategic thinking and analytical skills, and a results-focused orientation. About this company Bavarian Nordic A/S Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company’s lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company’s lead program is IMVAMUNE®, a non-replicating smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. ***************************************************************************

Jobs That Crossed My Desk Through August 25, 2013 ********************************************************************** http://www.linkedin.com/jobs2/view/6655680?trk=job_view_browse_map Regional Sales Manager – Life Science and Dx Tools Fluxion Biosciences - San Francisco Bay Area


Job function Sales, Science



9/2/2013 39

Job ID 6655680

Other Details About this job Job description This is an excellent opportunity for someone currently serving as a district/regional sales professional who wants to continue excelling in direct sales but also broaden their exposure and responsibility to include sales strategy, distributor/channel management, and international sales. Location: This position will be based out of Fluxion’s South San Francisco, CA headquarters. Consideration will be made for exceptional candidates that are based out of other key geographies. Fluxion is currently looking for an experienced Regional Sales Manager to lead the commercialization effort for the recently-launched IsoFlux System. This position is an excellent opportunity for an experienced sales professional to take on a significant role in the rapid commercial growth of a new instrumentation platform that will have a major impact in the field of cancer diagnostics. The successful candidate will be a natural ‘closer’ and contribute to both sales and business development activities as well as serving as a sales liaison to the project and management teams. This high visibility position will focus on the commercial adoption of the IsoFlux System within university, research center, biopharma, and clinical lab sites. The ideal candidate will have a background in sales and business development in the life science tools and diagnostics industry. A strong, verifiable track record of closing sales opportunities and exceeding projections is imperative for this role. This is a consultative sales role – the ideal candidate will able to maintain a high degree of technical knowledge and interact with high level customers across a variety of institutions. Fluxion Biosciences is a rapidly-growing bioanalytical tool company that is addressing critical needs in the pharmaceutical, biotech, diagnostics, and life science research markets. We are looking for individuals who will thrive in a fast-paced environment and can make meaningful contributions to the development and commercialization of our line of products for cellular analysis. Fluxion offers competitive salary, stock options, and a comprehensive benefits package (health, dental, vision, FSA, and more). The Sales Manager will: Maintain responsibility for hitting the sales targets of the IsoFlux System, both in the US

and internationally Manage the sales pipeline by accurately tracking sales opportunities according to

customer segment and progression towards closing Pursue sales prospects coming from a variety of sources (marketing and business

development activities) by offering sales presentations, technical consultations, evaluations, etc.

Work closely with the product and technical teams (field and in-house application scientists) to address customer inquiries and product evaluations

Conduct negotiations surrounding purchase orders, placements, etc. and ensure timely closing of opportunities

Analyze the key metrics surrounding progression of sales opportunities and be prepared to make recommendations to optimize the sales cycle and product positioning

Work closely with Fluxion’s network of international distributors to maintain sales targets in their geographies and close individual sales opportunities

Identify new areas of commercial growth for the existing IsoFlux product and make recommendations for future product development

Represent the product and company at US and international conferences and trade show exhibits

9/2/2013 40

Identify and pursue sales and business development channels beyond single institution sales, including: OEM, private label, CRO/Reference Lab, and Dx partnerships

To Apply: Please send Cover Letter and Resume using LinkedIn or to [email protected] (please include “Regional Sales Manager” in subject so it gets properly identified) Desired Skills and Experience Bachelors level degree in the biological sciences or engineering (MS, MBA, or Ph.D.

preferred) A MINIMIUM of 3 full years of post-graduate experience with a life science tools or

diagnostics company A MINIMUM of 2 full years of experience in a direct sales role for instrumentation /

capital equipment (>$10K) with ownership of territorial or product sales number Additional experience in marketing, business development, and/or product development

preferred Direct experience as a sales professional with a company in any of the following areas:

Oncology diagnostic instrumentation Biomarker testing / diagnostics Sequencing instrumentation or reagents qPCR / dPCR / multiplexed PCR instrumentation or reagents Pathology / microscopy instrumentation Ability to work both independently and within the team structure, good

teamwork attitude a must Ability to work in a fast paced and changing environment Flexible and quickly adaptable to changing priorities Excellent written and oral communication skills and meticulous record keeping Experience with sales CRM platforms (Salesforce preferred)

Moderate travel (20-40%) required to cover customer visits, conferences, and international distributors About this company Fluxion Biosciences Fluxion delivers advanced systems that automate complex cellular assays. Products include the IsoFlux system for circulating tumor cell analysis, the BioFlux system for functional analysis of cellular interactions, and the IonFlux automated patch clamp system. Hundreds of labs globally rely on Fluxion's solutions to research novel biology, accelerate drug discovery, and tailor therapies based on patient-specific biomarkers. ************************************************************************** Posted by Adriana Petersen, Executive Search for Life Technologies http://www.linkedin.com/jobs2/view/6924267?trk=eml-anet_dig-b_premjb-ttl-cn Leader (Director level) - Market Development - Human Identification Life Technologies - South San Francisco

Experience Executive




Job ID

9/2/2013 41

6924267 Committed to hiring veterans

Other DetailsAbout this job Job description The Market Development Leader serves as leader of the HID Global Market Development team, driving the marketing initiatives across multiple product lines and applications, including instrumentation, consumables, application specific kits and software, and/or strategic target markets. Contributes to the comprehensive business unit marketing plan to help achieve fiscal sales, marketing, and revenue goals globally. Works on strategic marketing plans for areas of responsibility by proposing, developing,

and executing detailed tactical program plans for campaigns supporting global regions. Ensure alignment of program plans among Market Development Managers, Product Managers and Regional Marketers, among other stakeholders.

Responsible for creation as well as region-specific deployment of disruptive Marketing approaches as well as viral marketing tools, so as to target awareness across the world and create a massive base for lead generation.

Ensure production of marketing materials described in marketing plans including, but not limited to: collateral, flyers, application notes, direct mail, eMarketing / Web. Act as project lead and liaison to internal and outside vendors, maintaining excellent professional relationships in order to facilitate the conversion of marketing ideas and messages into effective marketing materials and sales tools.

Develop and execute global marketing programs, including, but not limited to, product launches and sustaining programs described in marketing plans by development of appropriate sales tools.

Desired Skills and Experience Strong business acumen and understanding of the "big picture" Experience working across a complex organization in a matrix environment Track record of success leading people and business Experience in developing and deploying global integrated marketing programs. Experience with biotech and /or life sciences industry and related products in

sequencing and real-time PCR Experience developing & conducting product training for a wide variety of audiences,

including sales teams, regional marketing and customers Writing and editing skills, particularly for communicating scientific information,

applications, and articles of interest, accurately and appropriately to different target customer segments, including Scientific Buyers, Influencers, and Users

7 years of experience in similar positions in the field of forensics, genomics, molecular biology, or molecular diagnostics.

Developing and conducting market assessment surveys (e.g. kano, conjoint) Experience in selecting marketing methods and techniques Balancing process orientation with an appreciation for deliverables. Master’s or PhD in Biology, Genetics, Molecular Biology, Chemistry or a related field of

study. Bachelor’s degree plus 10+ years of experience may also be accepted. ************************************************************************ Apply on company website Home Based: Medical Director (Physician): Cardio– Serelaxin (Western US): Top Pharma Co: Major Cardio Drug Development [RETAINED SEARCH] Cornerstone Search Group - San Diego, CA (Covering west of Mississippi) work from home

Experience Executive

9/2/2013 42

Job function Research, Other, Science



Employer job ID srBH2088li

Job ID 6468161

Job description Summary: This is a key full-time position where you will be an employee of this Top 5 Global Pharmaceutical Company working on one of their largest and highest profile Clinical Development Programs for a new cardiovascular drug to treat Heart Failure. This is a key position critical to the success of the overall Clinical Development Program for this CV/Heart Failure drug. Work closely in the field with Hospitals, PIs and KOLs, regarding multiple medical, safety enrollment, and patient matters. Company Description: One of the most successful Global Top Pharmaceutical Companies that also has the richest and most extensive development pipeline in multiple therapeutic areas in the entire Pharmaceutical Industry. Location: Work from home– must be located west of the Mississippi and will cover the Western United States. Attractive Features about this Opportunity Be part of a team working on a very large, high profile cardiovascular / critical care

clinical trial (registration trial) Work closely with key PIs and KOLs Work from your home office and travel to sites and corporate headquarters as needed Join one of the most successful Pharma Companies in the World with the richest drug

development pipeline in the industry Responsibilities In a nutshell, for your assigned region, you will be the key contact for important PIs and KOLs involved with a very large, important and critical CV drug development program. This will include, but not be limited to: communicating/meeting with PIs and KOLs regarding clinical protocols, drug safety (AEs/SAEs), risk management, patient recruitment & inclusion/exclusion criteria, medical matters/issue. Also, you will work closely with Global Program Team Members based in the US and in international locations as well. Requirements/Qualifications/Experiences: MD degree 5 or more years of industry Clinical Development/Operations experience In-patient ICU/CCU critical-care clinical study/trial experience (ER setting where you are

dealing with a fast-moving patient situation and potentially multiple Physicians involved with the patients care). Obviously, this presents patient recruitment/enrollment challenges in this type of environment.

Feasibility studies: planned and conducted site multiple site feasibility studies/visits CRO experience where you have dealt directly and/or managed CRO resources Clinical Operations experience where you have dealt directly with the Clinical Operations

people/team on clinical studies/trials Confidentiality/privacy All inquiries and submissions are held in strict confidence, i.e. no information provided to us by you will be shared with any parties outside of Cornerstone Search Group without your permission to do so. Steven Raz | Co-Founder & Managing Partner

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U.S. Number: +1 973 656 0220 ext. 712 | [email protected] Basel, Switzerland Local Number: +41 61 508 7010 www.linkedin.com/in/stevenraz Cornerstone Search Group, LLC Life Sciences Executive Search 6 Campus Drive | Parsippany, NJ 07054 Our Open Positions:http://cornerstonesg.com/Search_Jobs_Results.aspx Keywords: Work at home, Home Based, Cardio, Cardiovascular, Critical Care, Heart, AHF, Acute Heart Failure, Stroke, ER, Emergency Medicine, Novartis, Serelaxin, MD, Medical, Physician, West Coast Desired Skills and Experience Requirements/Qualifications/Experiences: MD degree 5 or more years of industry Clinical Development/Operations experience In-patient ICU/CCU critical-care clinical study/trial experience (ER setting where you are

dealing with a fast-moving patient situation and potentially multiple Physicians involved with the patients care). Obviously, this presents patient recruitment/enrollment challenges in this type of environment.

Feasibility studies: planned and conducted site multiple site feasibility studies/visits CRO experience where you have dealt directly and/or managed CRO resources Clinical Operations experience where you have dealt directly with the Clinical Operations

people/team on clinical studies/trials ************************************************************************ Posted by Lucy (Jinglucy) Sun, Scientist | Project management | Customer-focus | Assay Development http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=268235539&gid=3412079&trk=eml-anet_dig-b_jb-ttl-cn&fromEmail=&ut=2hfERzQz76iBU1 Bio-RAD: Field Applications Specialist/Tactical Applications Laboratory Manager Location: Hercules, CA (SF Bay Area) If you are interested, I can connect you with the hiring manager for the job. Job Description: The Technical Support Group has a challenging career opportunity for a talented and highly-motivated individual who would like to apply their scientific acumen and technical skills to support Bio-Rad’s Life Science internal and external customers in North America. The successful candidate will be expected to develop rapidly into a subject matter expert on both the Bio-Plex (otherwise know as Luminex xMAP) technology and Bio-Rad’s Next Generation Chromatography (NGC) Systems and to provide support to customers, as well as Bio-Rad’s sales representatives and Regional Field Application Specialists who are based across the US and Canada. The chosen applicant will also be expected to interact regularly with multiple in-house groups who play a key role in supporting these product lines, including Technical Support, Marketing, R&D, Manufacturing and Quality Control (QC). Travel Requirements for this position are 25-50%. Job Duties: • Provide pre- and post-sales trainings or presentations to customers on Bio-Plex Systems and Assays, or NGC Systems.

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• Act as a technical consultant for Bio-Rad sales representatives and Regional Field Application Specialists on the Bio-Plex and NGC product lines. • Provide assistance to Technical Support in troubleshooting customer issues which cannot be resolved by phone or email. Examples might include running an instrument, or performing an assay with the customer at their site, or testing customer samples in-house. • Design and execute training curriculums for customers, sales representatives, or Regional Field Application Specialists on Bio-Plex or NGC products. • Design and execute comparison studies between Bio-Rad and competitor products in support of Marketing and R&D efforts. • Generate technical data, quick guides, or other informational material to address common customer FAQs. Work with Marketing on sales collateral. • Maintain and manage the Tactical Applications Laboratory (TAL). Keep inventory of equipment and ensure equipment is operational and lab is stocked appropriately for trainings, or other activities which someone in this position will need to perform in the lab. • Attend New Product Development (NPD) and Quality Meetings to provide first-hand feedback and insight into customer needs, requirements, or issues. • Act as an internal “beta” tester for software, products, kits in the Bio-Plex, or NGC product lines. Required Experience: • Ph.D. in Molecular Biology, Immunology, Cell Biology, Biochemistry, or equivalent discipline. • Hands-on experience with ELISA and Western blot essential. Experience with Bio-Plex or Luminex xMAP technology a definite plus. • Hands-on experience with Lab Scale Chromatography Systems. Experience with HPLC/FPLC. • Excellent communication and presentation skills. • Good laboratory technique, attention to detail and problem-solving skills. • Field experience a plus. ************************************************************************ Contact the job poster Reach out for more information or to follow up on your application Cynthia Grant [email protected] Neurology Sales Specialist GrantProSearch - Santa Monica/Beverly Hills, CA Posted 1 day ago Apply nowSavedUnsaveSave


Job function Sales



Job ID About this job Job description Leading pharmaceutical organization seeks specialt ypharmaceutical sales representative to sell company products to Neurologists/Psychartist. Territory is Santa Monica/Beverly Hills.

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Client prefers candidates that have current experience calling on Neurologists,CNS experience. Client is a top pharmaceutical organization that is one of few that has not seen lay offs! Desired Skills and Experience BA/BS required 3-8 years of extremely successful pharmaceutical sales experience Neurology sales experience preferred Solo peformance preferred Must have documented sales success Must be articulate and very driven Must be able to passionately describe sales successes Must have stable work environment Must live in the territory About this company GrantProSearch GrantProSearch assists healthcare companies; pharmaceuticals, bio-technical, medical diagnostics, medical device, hospitals and clinics as well as partnering with start up organizations for their professional staffing needs. Each search is treated individually with the knowledge and expertise of your market segment. GrantProSearch team members devote the requisite time in identifying qualified candidates who meet the specific criteria of each client. GrantProSearch's objective is to ensure the candidate’s interest and excitement about your opportunity. We understand our client’s need to select from a narrow list of professional candidates quickly so that they can reduce their hiring costs. We are a certified member of the Women's Business Enterprise National Council. And we serve as a board member on First Interview Company, a network of over one hundred and twenty healthcare industry recruitment firms. ************************************************************************ http://www.bullhornreach.com/job/996964_diabetes-sales-specialist-byettasymlin-santa-barbara-ca?utm_campaign=v1&shortlink=2655845&utm_content=5&utm_source=linkedin.com&referer=www.linkedin.com&utm_medium=referral Diabetes Sales Specialist (Byetta/Symlin) This position is for a professional sales representative for the Diabetes sales team within the DS3 Diabetes Specialty Division at Bristol-Myers Squibb. The position is located in Santa Barbara, CA. Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), medical group practices, hospitals, pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Bachelor's degree or equivalent is required. Proven track record in customer service industry is required along with 2 years of sales related experience. Demonstrated success in medical related sales advantageous. A strong customer focus and analytical skills to identify and prioritize business opportunities is

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required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge required. ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=E5B7970B-E79F-44C0-9A87-C1BC8ABC26F1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 HEALTH CARE COMPLIANCE OFFICER Johnson & Johnson Job Description HEALTH CARE COMPLIANCE OFFICER (Job Number:0591130616) Description: Johnson & Johnson is looking for an HCC Officer for Acclarent Inc located in Menlo Park, California and Cordis Corporation located in Fremont California. The companies are part of the Johnson & Johnson family of companies in the Medical Device sector. This Officer position will provide HCC support and oversight for both companies. Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. Acclarent is a medical technology company dedicated to designing, developing and commercializing technologies that address conditions affecting the ear, nose and throat. The company was founded in 2004, was acquired by J&J in 2010. It is a growing company currently with about 350 employees, a US sales organization of about 150, and worldwide sales of approximately $200MM. Cordis Corporation is relocating the company's headquarters to Fremont, California. Cordis is a pioneer in less invasive treatments for vascular disease specializing in interventional medical procedures in cardiovascular, endovascular, and biliary duct (liver) treatments. Cordis sales are approximately $840MM worldwide with about 700 employees and a US sales organization of 225 people. As HCCO, the person in this position will serve as the HCC Officer for both Acclarent and Cordis providing support for the management boards, chairing its HCC Committees, and providing compliance support for key headquarters functions. HCC officers implement and maintain programs that support compliance with HCC laws, regulations and industry standards related to the promotion and marketing of health care products and services, interactions with health care professionals and/or government officials, including, as applicable to the business activities, FCPA and other anti-corruption laws, off-label promotion, anti-kickback and false claims statutes, compliance with corporate integrity agreements, deferred prosecution agreements or other settlements. The HCCO partners with company leadership (sales, marketing, R&D, HR, etc.,) to implement and maintain that Health Care Compliance programs that prevent and/or detect violations of law, regulations, and company policies. He/she will be acting as a consultant, reviewer and approver as needed, for business activities that involve HCC risks. This individual will be providing appropriate guidance, education, training, and regular communications on HCC to all relevant employees. He/she will support the risk assessment process, testing & monitoring efforts, external audits and reviews, corrective actions, response to reports of potential misconduct, and other elements of the companies' compliance programs. The Acclarent and Cordis HCCO will provide strategic support to senior management at the business units regarding potential compliance risks, compliance-related incidents and investigations, and trends, root causes, and recommend and implement appropriate action plans. He/she will participate in cross-company or cross-sector compliance initiatives within

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J&J, as necessary, and provide support to J&J HCC senior management. This individual will interface with legal counsel regarding HCC requirements and interpretation. The HCCO will partner with colleagues within the Global Surgery Group and J&J HCCP to drive the adoption of more efficient or effective HCC related practices. This individual will support the efficient implementation of the US Sunshine Act reporting obligations, and will analyze metrics at the operating company level and provide analysis to Global Surgery Group Leader and others as appropriate. The Acclarent and Cordis HCCO will manage a HCC Manager and have dotted line management of a second HCC manager who support the HCC programs at each operating company. This role includes actively engaging in the enterprise-wide Talent Management process for HCC to include establishing goals and objectives, giving direction, support, and periodic feedback to direct reports pursuant to Human Resources policies. He/she will provide technical subject matter expertise, advice and development opportunities to direct and indirect reports. Qualifications: A minimum of a Bachelors Degree is required. A minimum of 6 years of business experience, with at least five years in health care compliance, government contracts compliance or related compliance area is required. Current status as a Certified Compliance & Ethics Professional (CCEP®) or Certification in Healthcare Compliance (CHC®) preferred. Knowledge of healthcare fraud and abuse, anti-corruption and false claims laws is required. Knowledge of laws and regulations governing health care reimbursement is required. Knowledge of laws and regulations concerning the marketing and promotion of medical devices is required. Knowledge of financial or auditing practices is required. Knowledge of current standards and guidance concerning corporate compliance and ethics programs is required. Demonstrated experience in the development and implementation of a compliance program in accordance with the organization's risk profile is required. Exceptional written and verbal communications skills are required. Experience with project management in a matrixed business organization is preferred. Strong communication skills, organizational skills, and analytical skills are required. Broad business experience and a proven ability to influence business decisions and business partners are required. Ability to think strategically, develop and execute longer-term objectives is required. Ability to take complex business situations and develop solutions that ensure compliance is required. Proven track record in delivering results, self starter and ability to manage complexity is required. Ability to work well between functions and across all levels of the business and effective negotiating skills is required. Ability to comprehend and interpret legal documents is preferred. Proven success at managing and developing talent is required. This position will be located in Menlo Park, CA and Fremont, CA and will require up to 20% travel. Primary Location: North America-United States-California-Fremont Other Locations: Organization: Johnson & Johnson (6067) Job Function: Health Care Compliance ********************************************************************** Major med device Silicon Valley leader seeks talent in global product mgmt; customer segment marketing mgmt; business channel development; and product marketing mgmt. Contact me: [email protected] If you or your talented colleagues are interested, contact me ([email protected]) for further information. Will provide your information to Manager internal to orgn. ********************************************************************** http://www.linkedin.com/jobs2/view/6624339?trk=eml-anet_dig-b_premjb-ttl-cn Project Manager Planet Pharma - San Francisco Bay Area


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Job function Consulting

Employement type Contract

Industry Pharmaceuticals, Biotechnology

Job ID 6624339


Job description Ensure improvement methodology and tools are utilized effectively to maximize benefits . Deliver project goals on budget and on schedule . Develop conceptual customer needs into an approved project charter . Analyze business, process and systems performance, and identify improvement opportunities . Develop, evaluate and manage business case and cost/benefit analyses . Provide decision support and recommendations to select best options . Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution . Develop and use project plans to coordinate participants and track and report progress . Leverage industry research and analysis; serve as advocate & role model for integrating best practices into the organization . Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals Desired Skills and Experience Collaborative Leadership- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity, able to create order from chaos. Ownership and Accountability . Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted . delivers of promises, goals, and expectations. Makes quality decisions and resolved problems rapidly. Communication-Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity. Planning/Organization-Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite nshifting environment. Analytical Problem Solving . Ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution. Education: BS/BA (Engineering/Science preferred). Minimum 7 years of related analytical and business experience working in a complex. Manufacturing and/or Engineering environment (biotech/pharmaceutical industry or familiarity with cGMP's a plus). Minimum 3 years Project Management experience. Experience with implementation of process improvement initiatives

About this company Planet Pharma Following companyUnfollow companyFollow company Company Overview: Planet Pharma was founded by a seasoned group of professionals with over 50 years of Clinical & Scientific staffing and outsourcing experience and is one of the first “Green Staffing Companies” in Illinois. Through the use of cutting-edge technology and a service delivery model based on a paperless work environment, Planet Pharma can make an immediate impact for your Pharmaceutical, Biotechnology or Medical Device organization. We provide the following solutions: Contact Staffing, Outsourced Projects, Permanent Placement and Managed Service Provider

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Specialities: Clinical & Scientific Staffing, Technology Staffing, Site Management & Monitoring, Clinical Project & Program Management, Clinical Programming & Data Management, Biostatistical Analysis & Reporting, Pharmacovigilance, Medical Writing, Regulatory Affairs, Quality Assurance and Validation. Planet Pharma is headquartered in Chicago, IL and has a regional office in Cleveland, OH. Website: http://www.planet-pharma.com ******************************************************************* APPLY TODAY Please apply via this website, via our website at www.McKesson.com/careers or send your resume directly to [email protected]. Senior Program Manager (EHR/Meaningful Use) - 74534 McKesson - The Woodlands Posted 2 days ago Apply nowSavedUnsaveSave


Job function Product Management


Industry Hospital & Health Care

Employer job ID JD 74534

Job ID 6744706


Job description Senior Program Manager, Enabling Technology POSITION OVERVIEW Program Manager will coordinate and drive the various groups, stakeholders and client activities across multiple stakeholder interests to accomplish strategic initiative objectives and deliverables. This individual will serve as subject matter expert and driver of key programs that align with strategic initiatives. The program manager will also help define and drive the project schedule, and be responsible for the overall program, deadlines, and be expected to define and deliver on program expectations. 74534 Initial strategic program focus will primarily be Meaningful Use and PQRS. More than 1000 providers plus their clinical and administrative support staff will be impacted by Meaningful Use and PQRS equating to $40M+ in potential incentives to physicians and $50M+ in penalty avoidance at minimum over the life of Meaningful Use. To lead this change over the lifespan of Meaningful Use, McKesson Specialty Health needs a strong leader well versed in program and change management, technology adoption, and process design in a clinical environment. Meaningful Use program core goal is to sustain and ideally improve current Stage performance

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while creating and deploying methodology to successfully prepare for and execute future Stages. RESPONSIBILITIES Leads strategic programs through collaboration, communication, and the

creation/execution of integrated work plans. Revises approach as appropriate to meet changing needs, requirements and strategic goals.

Manages day-to-day operational aspects of programs and scope. Develops and manages delivery of program tools, methodology, metrics, and services while staying under the department budget. Identifies resources needed and assigns individual responsibilities in coordination with management.

Delivers methodology to meet practices’ need to improve quality, workflow & performance; while realizing through program success gains in patient service, value of technology, and financial benefit. Provides educational information and materials for trainers and stakeholders/customers

Provides program coaching and support to The US Oncology Network and open market practices, while also coaching others resources to help support practices. Facilitates and conducts events to support strategic initiatives and ensures program documentation is complete, current, and stored appropriately for stakeholders to access.

Assists various product stakeholders with products needed to successfully achieve strategic initiatives. Advises on reporting and product (e.g. EHR, portal, MU reporting, etc.) development, training support, and process design; for example, translating EHR certification into objective focused workflow.

Identifies business development and "add-on" service opportunities as needed. Manages relationships and contracts with outsourcing groups to deliver services/training, as needed.

Desired Skills and Experience QUALIFICATIONS / MINIMUM REQUIREMENTS Education/Training 4-year degree in related field or equivalent experience Equivalent experience: Seven to ten years increasingly responsible experience in

project management or product management experience Business Experience 8+ years experience working in healthcare Thorough knowledge of healthcare initiatives and company's products; ability to collect

and analyze market trends and customer needs Experience managing multi-disciplinary projects or programs Exposure to Meaningful Use , PQRS or other programs Experience in driving adoption of technology; specifically ambulatory EHRs, portals,

quality measurement systems and reporting tools Specialized Knowledge/Skills Strong knowledge of clinical and operational processes (oncology experience is ideal) Ability to write and support training documents Solid communication skills Experience with MS Project and MS Office Suite Working Conditions Can be remote based Travel up to 50% - on site with clients, medical society meetings and trade shows

About this company McKesson ABOUT McKESSON Making a difference starts with you. It can be as simple as helping a customer or as complex as creating lifesaving technology. When you work with McKesson, you initiate a chain of events that results in millions of people getting more from their healthcare.

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As the nation’s leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower all 32,000 of our employees through a collaborative environment that supports employee network groups and diversity councils. In our inclusive community, opportunity and responsibility grow. At McKesson, we believe we can empower healthcare. And it all starts with you. ************************************************************************* https://jobs.smartbrief.com/action/listing?listingid=DFC959F2-A24C-4A69-B042-3BCCF5CADD51&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director Regulatory Affairs - Operations - 13000005VB Abbott Job Description Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning: • Identify need for new regulatory policies, processes and SOPs and approve them • Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture • Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions • Develop global regulatory strategies and update based upon regulatory changes • Conduct regulatory due diligence for potential and new acquisitions and advise management • Sets quality and accuracy standards • Anticipate emerging issues and develop solutions to them • Develop solutions to address issues with other members of management and stakeholders • Develop corporate positions on regulatory risk-benefit • Create and develop product positioning strategies based upon regulatory requirements • Integrate regulatory considerations into the corporation’s global product entry and exit strategy • Recruit, develop, and mentor regulatory professionals • Provide guidance for resource and development planning • Participate in applicable trade association/industry working groups to influence policy/rule making in alignment with business strategies Premarket: • Communicate application progress to internal stakeholders • Negotiate with regulatory authorities during the development and review process to ensure submission approval • Provide strategic input and technical guidance on regulatory requirements to development teams • Ensure preapproval compliance activities are completed • Formulate company procedures to respond to regulatory authority queries Postmarket: • Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests • Ensure a system is in place to manage access to information requests

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• Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance • Ensure crisis management program implemented and functioning • Identify and present option for risk mitigation to decision makers • Represent regulatory affairs in product recall and recall communication process • Ensure adverse events are reported to regulatory agencies and internal stakeholders • Manage processes involved with maintaining annual licenses, registrations, listings and patent information • Ensure compliance with product postmarketing approval requirements • Review and approve advertising and promotional items to ensure regulatory compliance • Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information Job specific responsibilities may include (choose applicable areas and expand as appropriate); • Medical writing • Advertising and promotion • Labeling • Controlled substances (e.g. DEA) • Restricted substances (e.g. REACH) • Compendial / standards • Import / export • Country specific regulatory support Influence/Leadership: • Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation. • Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives. • Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. • May lead a project team or initiative within department or cross-functions/divisions. • Provides technical leadership to business units. • Acts as a mentor to less-experienced staff internal and external to the department/division. • Exercises judgment independently. • Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives. • May participate / lead external industry working groups to influence advocacy in alignment with business strategies. Planning/Organization: • Creates mid- to long-range plans to carry out objectives established by top management. • Develops and calculates a budget for one or more departments to meet organizational goals. • Forecasts future departmental or group needs including human and material resources and capital expenditures. • Determines and establishes organizational structure and supervisory relationships subject to top management approval. Decision Making/Impact: • Assignments are expressed in the form of objectives • Work is performed without appreciable direction. • Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. • Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

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Minimum Education Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience / Training Required 7-10 years experience in a regulated industry (e.g., medical products, nutritionals). 7-10 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Background / Skills / Knowledge Regulatory Knowledge of (as applicable): • Regulatory history, guidelines, policies, standards, practices, requirements and precedents • Regulatory agency structure, processes and key personnel • Principles and requirements of applicable product laws • Submission/registration types and requirements • GxPs (GCPs, GLPs, GMPs) • Principles and requirements of promotion, advertising and labeling • International treaties and regional, national, local and territorial trade requirements, agreements and considerations • Domestic and international regulatory guidelines, policies and regulations • Ethical guidelines of the regulatory profession, clinical research and regulatory process Technical/Business Knowledge of: • Monitor costs of projects and of human and material resources within a department or unit • Monitor company-wide indicators such as market share and profitability • Develop least cost, least time means to provide optimal regulatory support for new products • Monitor external environment in area of technical or professional responsibility • Direct and manage the preparation of technical strategic regulatory documentation for agency submission. • Understand of reimbursement Communication Skills or Ability to: • Communicate effectively verbally and in writing • Communicate with diverse audiences and personnel • Write and edit technical documents • Work with cross-functional teams • Work with people from various disciplines and cultures • Write and edit technical documents • Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies • Negotiate internally and externally with regulatory agencies and participate in political lobbying • Plan and conduct meetings • Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks

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• Effectively negotiate regulatory agreements with global regulatory agencies • Negotiate regulatory and scientific issues with management • Adjust presentation style and content to suit the audience Cognitive Skills or Ability to: • Pay strong attention to detail • Manage projects • Create project plans and timelines • Must be able to juggle multiple and competing priorities • Think analytically with good problem solving skills • Organize and track complex information • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results • Has broad knowledge of various technical alternatives and their potential impact on the business • Exercise good and ethical judgment within policy and regulations • Plan and implement most appropriate strategy to obtain product licensure in least amount of time worldwide • Use in-depth knowledge of business functions and cross group dependencies/ relationships • Define regulatory strategy • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues • Perform risk assessment or analysis • Counsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to business. • Develop and/or identifies new work processes that will have broad applicability throughout the company Lead functional groups in the development of relevant data to complete a regulatory submission *************************************************************************** Anyone interested please contact Sandy Huynh, Staffing Consultant, 650 372-7104 / [email protected]. Gilead is looking for a Research Scientist II - Bioinformatics (a PhD with 3+ years of experience in oncology ideally, R language is a must to analyze microarray and next generation sequencing data. Perl/Linux are good to have but not required). Please visit www.cbasf.org for detailed description. Other open positions are at the CBA site or sponsor sites such as www.gilead.com or www.alexza.com. ************************************************************************* Contact Person:Dario A. Paggiarino, MDEmail Address: [email protected] Position Title: Project Lead, Development Date: July, 2013 Company Description: Lpath, Inc. is a San Diego based therapeutic antibody company, and the category leader in lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company has developed three drug candidates: iSONEP™, a

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monoclonal antibody against sphingosine-1-phosphate (S1P), is currently in a Phase 2 trial for wet AMD; ASONEP™, also a monoclonal antibody against S1P, is in a Phase 2 clinical trial as a treatment for renal cell carcinoma; and Lpathomab, an antibody against lysophosphatidic acid, is a preclinical drug candidate that holds promise in pain, neurotrauma, and other diseases. Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. For more information, visit www.Lpath.com. Position Summary: The candidate will lead early development projects to ensure project goals are met by organizing and implementing activities defined by project plans. Under the direction of the SVP and Chief Development Officer, the candidate will represent the single point of accountability for the individual early development project(s) from IND-enabling studies through Phase 2. The candidate will lead implementation of pre-clinical, clinical, regulatory affairs and project management activities through interaction with internal colleagues and/or external consultants and service providers to integrate project efforts across disciplines. A strong background in CMC operations in the area of biologics would be a plus. Job Requirements Specific Responsibilities & Duties:

Lead the development of one or more antibodies from IND-enabling studies through clinical PoC; specifically, lead—and be accountable for—all development activities in key technical areas such as CMC, pre-clinical safety and ADME, clinical development, regulatory affairs and project management in accordance with the early development plan.

Manage the individual projects to optimize resources and maximize the probability of success and the probability of timely completion

Proactively identify risks, assess their magnitude, and propose plans/strategies to mitigate them.

For major decision points, analyze data with the project team, put into strategic perspective, and propose recommended plan of action to management.

Between major decision points, analyze any new information and foresee its impact on project strategy and probability of success; recommend to management necessary change in strategy/objectives.

Ensure high quality and content of all project / program documentation. Work effectively either independently or within project teams to multi-task and work

under tight deadlines. Ensure appropriate internal/external communication about the projects and program in

accordance with corporate policy. Report directly to the Chief Development Officer and align with Lpath vision and R&D

strategy. Qualifications:

B.S. degree or higher in Biological or Physical Sciences. 5+ years' experience, preferably 10+,in the pharmaceutical industry in managerial

positions. Previous experience in GMP pharmaceutical development of biologics in the area of CMC

operations would be strongly desirable. Enthusiasm, willingness to learn, strong work ethic, broad scientific interests and

attention to detail. Demonstrated ability to work in a small-company team environment and excellent

oral/written communication skills. ***********************************************************************

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Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Interested parties should contact/send resume to [email protected]. No Work Visa sponsorship is available for this position. Manager, QA /QC – Full Time Position (San Francisco Bay Area) To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. DESCRIPTION: • Oversee the development, implementation and maintenance of quality assurance and quality control systems and activities • Oversight and leadership of the QA/QC staff in the raw material lab, finished goods lab as well as to ensure proper control of the QA activities and GMP practices • Provide leadership and direction to the QA/QC team, to oversee and manage assigned staff including hiring, firing, work assignment, performance management, training and professional development. • Manage, evaluate and develop quality systems and processes for the inspection, testing and evaluation of company products. • Ensure processes and work standards are being followed by staff to ensure company products are precise accurate and reliable. • Develop budget and monitor expenditures for the department. • Assure finished products conform to government and company standards and satisfy GMP regulations. • Support customer and regulatory audits EXPERIENCE AND QUALIFICATIONS: • Proficient in Microsoft Word, Excel, and PowerPoint • Strong communication skills • Well organized and able to multi-task http://www.jgbbiopharma.com/jobs-category/quality-jobs ************8**************************************************************

Jobs That Crossed My Desk Through August 18, 2013-08-21 ************************************************************************ Apply on company website Director of Product Marketing IMS Health- San Francisco Bay Area Job Description At IMS Health, we tap the very best people, and then give them meaningful work to do. We don’t simply think about careers, we think about contributions. Those who choose to work with us are joining a recognized global leader — a company uniquely positioned to help clients make the most of market opportunities and respond to challenges that affect global healthcare. We’re committed to blending industry expertise and advanced technology to deliver the most accurate perspectives and in-depth analytics on healthcare dynamics. The key to our success is our people, whose experience, talent, commitment and diversity set the standard for the health information industry. Total Rewards We invest in people through a range of initiatives in compensation, benefits, and learning and development, and we strive to create an environment where our employees are challenged, empowered and can flourish. About Clinical Trial Optimization Solutions: IMS Health Clinical Trial Optimization Solutions (CTOS) is the leading provider of Trial Optimization Software Solutions to the Pharmaceutical and Biotechnology Industry and is entering a hyper-growth stage. Our flagship products, StudyOptimizer™, the industry’s first enrollment optimization solution for clinical trials, and GrantPlan™, the industry’s leading cost

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benchmarking and online negotiation tool, provide a solid platform for expansion of our product set. An integrated suite of process automation, predictive analytics, scenario modeling, enterprise data integration and visualization capabilities, our product set significantly reduces clinical trial costs and improves clinical operational efficiencies and effectiveness. Role Summary: The Director of Product Marketing will be responsible for developing, delivering, and driving the company’s product marketing strategy, positioning and messaging for our solutions. This means identifying robust market opportunities, defining key market differentiators, identifying market requirements and driving those back into the product teams, developing optimal positioning and messaging and guiding commercialization through the product launch process and the appropriate mix of outbound channels. This includes supporting the development and implementation of marketing initiatives, product collateral (both technical and promotional), selling aids, demonstrations and presentations. The scope of this position includes directly supporting the field organization by participating in qualified customer and prospect meetings to optimally position IMS CTOS product portfolio with the account. In addition, the Director of Product Marketing will partner with the CTOS product management team in securing innovative product and market requirements and driving product/market research into the product development process. For the experienced product marketing professional that has a successful track record of building, launching and growing software, business intelligence or clinical management solutions into the Life Sciences industry, this is a significant career opportunity. Responsibilities:

Develop and execute comprehensive product marketing strategies that: o Yield commercially successful solutions with significant growth and revenue

impact o Drive awareness of and usage of CTOS solutions

Define and manage the overall product marketing strategy and positioning for CTOS products; Serve as a product expert in dealings with thought leaders, analysts and press

Influence the product solution strategy and roadmap by capturing, analyzing and documenting market requirements, performing product line business and profitability analysis, sales win/loss analysis, evaluating product pricing

Develop a deep understanding of customer and market needs and behavior through primary and secondary research, market trends and competitive analysis and positioning

Develop and implement marketing initiatives, product collateral (both technical and promotional), selling aids, demonstrations, websites, presentations, whitepapers, articles, customer success story programs and webinars, newsletters and surveys, trade shows and company-sponsors seminars, customer advisory board and user group, etc

Work across the organization to drive sales, marketing, and partner strategies required for business and product launch success

Travel expectations – 25% Desired Skills & Experience Critical skills:

Strong creativity and innovation in positioning, messaging, differentiation, and go-to-market plans

World-class content creation Outstanding written and oral communication skills Strong organizational and analytical skills Team player Self starter who is comfortable working in a fast paced software environment

Requirements: Minimum 7 years experience in enterprise software product marketing

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Life Science, R&D, clinical background and knowledge of clinical trial sponsor and CRO segments of the market strongly preferred

Successful track record of developing and commercializing new software applications with significant revenue and growth in the Life Science industry

Proven track record in developing and implementing product marketing and strategic business plans for solutions that have positive market and business impact

Experience in documenting market requirements and driving requirements through software development process

Focus on business intelligence applications, predictive analytics, data integration solutions and web-services strongly preferred

Proven ability to manage multiple projects, set priorities and meet deadlines Experience in fast-paced environments with overlapping projects/deliverables

Education/Training: Bachelor’s degree required; Masters or MBA degree a plus

Company Description IMS Health is a leading provider of information, services and technology for the healthcare industry around the world. The company draws on its global technology infrastructure and unique combination of in-depth, sophisticated analytics, on-shore and off-shore commercial services, and consulting platforms to help clients better understand the performance and value of medicines. With a presence in 100+ countries and more than 55 years of industry experience, IMS serves leading decision makers in healthcare, including pharmaceutical manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. Ari Bousbib is IMS Health’s Chairman and Chief Executive Officer. Bousbib came to the company in August 2010 from United Technologies Corporation. IMS provides solutions in Healthcare Analytics and Services, Healthcare Measurement and Consulting. Additional information is available at http://www.imshealth.com. Additional Information Posted:July 25, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing, Product Management, Other Industries:Market Research, Pharmaceuticals, Information Technology and Services Job ID:6583859 ************************************************************************* Apply on company website MANAGER, MARKET INSIGHTS AND COMPETITIVE INTELLIGENCE Abbott- Oakland, US-CA (San Francisco Bay Area) Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. PRIMARY FUNCTION: This position is tasked with providing Primary and/ or Secondary marketing research and analytics support to the marketing and sales organizations within the Diabetes Care division. This person will provide direction and input to marketing, sales and forecasting related activities. Ability to understand the business needs and to develop and communicate information around these needs will drive success within this position. Reports directly to the Market Research Manager or Director.

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MAJOR RESPONSIBILITIES: Partners with Marketing and commercial leadership to identify research and analysis needs. Design appropriate research and analysis plans based on understanding of available research and analytical techniques Strong organization skills needed to manage research supplier(s) on cost, timing, appropriateness of research methodology, and actionability of conclusions Analyze and synthesize learnings from research and analysis , drawing conclusions that provide recommendations to business teams Utilizes knowledge of standard research and analytic methods to distill information into clear, concise communication oIndependently seeks and leverages market research and analysis peers and leaders, business partners and external vendors to ensure strong analysis and sound recommendations Exhibits strong analytic abilities in breaking down issues and developing solutions Translates results into clear, concise presentations and written reports, enabling brand and innovation team to quickly make marketing decisions Analyzes categories on a macro level utilizing multiple information sources (primary, secondary data and syndicated studies) to provide actionable consumer and business insights oUnderstands the market place, competitor dynamics and provides expertise on data interpretation for the marketing and sales organizations Partners with marketing managers, forecasting and finance in the planning process Displays a positive, solutionbased approach to all research issues and ability to work in teams. Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation. ACCOUNTABILTY / SCOPE / BUDGET: Primary support for providing market and customer information to the marketing, sales and forecasting organization Champions primary and / or secondary market research information within the Diabetes Care division Understands the market place and competitor dynamics and provides expertise on data interpretation for the marketing and sales organizations Partners with marketing managers, forecasting and finance in the planning process and provides a robust understanding of customers, competitors and consumers Desired Skills & Experience Bachelor's degree required. Master's degree preferred. Candidate must have a minimum of 5 years working experience in the market research and analytics field in industries such as Healthcare, Consumer Packaged Goods, Medical Devices or Pharmaceuticals or similar industries.

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Experience with secondary data analytics is preferred. Expert level Excel skills (create, amend, manipulate spreadsheets) required. Additional Information Posted:July 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Biotechnology, Market Research, Marketing and Advertising Compensation:0 Employer Job ID:13000005MT Job ID:6513695 ************************************************************************ Apply on company website Product Director, U.S. Oncotype DX Marketing Genomic Health, Inc.- Redwood City, CA (San Francisco Bay Area) Job Description Genomic Health is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.org POSITION SUMMARY: The Oncotype DX U.S. market Product Director is responsible for leading the cross-functional Breast Cancer product marketing efforts, Commercial Team and the overall commercialization of the Oncotype DX Breast Cancer Assay. The Product Director will also prepare new product assessments for the breast cancer franchise and will be responsible for launch plans for product extensions taken to U.S. market. The Product Director will also manage, coach and develop a team of Product Managers who are responsible for executing key components of the Brand Plan. This person will also be the lead for managing Advertising Agency projects for this product and geography. This comprehensive commercial responsibility will require a clear and directive style that is able to engage a broad set of teams to work cohesively and efficiently in a fast paced setting. Success in this position will require, broad strategic thinking, strong clinical knowledge, attention to detail and the ability to carry out multiple tasks in parallel in a dynamic and demanding cross functional team environment. Competitive candidates will possess significant, relevant marketing experience in the field of breast cancer, with a demonstrated ability to master complex scientific material and demonstrated ability to work with US thought leaders and other physicians. Competitive candidates will require strong presentation skills as they will be presenting to diverse audiences, including the field sales force, executive team, and medical teams, as well as potentially external audiences.

Develop a comprehensive Brand Plan for the Oncotype DX Breast Cancer Assay as well as product extensions, including branding/positioning/messaging/promotional and competitive strategies and supportive clinical development/medical affairs activities.

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Establish a clear and aligned communication plan that leverages the publications and timing to align for subsequent materials and direction for field sales force.

Develop promotional tools including brochures, advertisements, and online content to convey messages and support awareness, education, and in doing so optimize the Channel Strategy for the Oncotype DX Breast Cancer Assay.

Ensure comprehensive training of the Sales force on key data, key messages, positioning, competitive strategies/positioning and all promotional tools and programs.

Analyze current market research in order to drive plans and coordinate all future market research, working closely with Market Research Analyst.

Prepare short-term and long range sales forecasts for Management Review. Accountable for breast franchise deliverables for corporate planning (to include

Integrated Strategic Planning, Brand Planning, Long Range Planning and Operating Planning processes).

Manage marketing budget for breast franchise. Work closely with field sales and managed care teams to develop and train on

positioning and messaging for rapid adoption and customer education. Present a variety of material in front of diverse audiences, from All Company Meetings

to Field Sales Meetings, Trade Shows, Executive Meetings, board meetings, and other relevant audiences. The ability to inform and inspire is critical.

Exhibits strong people management and leadership skills, coaching, inspiring and mentoring direct reports within the team and across the Commercial organization.

Develop national breast cancer thought-leader advocates & coordinate participation in advisory boards and speaker development programs.

Work with the Corporate Communications & Advocacy team to develop consistent messages, and innovative digital/social media programs for Media and Patient audiences.

Master complex scientific information at a high level in order to analyze clinical studies by Genomic Health and other parties in the field of genomics and present this analysis to diverse audiences.

Maintain professional, engaging and patient focused communications with all internal and external audiences. We are an organization that must be firmly committed to premium customer service.

Maintain confidentiality as it pertains to sensitive scientific data, HIPAA protected information, SEC-protected filings and other designated topics, at all times.

Oncology experience required with strong preference for candidates who have worked directly with key opinion leaders in breast cancer in the USA.

Experience in the commercialization of oncology diagnostics would be an advantage. Strong leadership skills are required. Relevant experience in a tightly-controlled, regulatory environment and with managed

care. Proven analytic skills with scientific papers and market intelligence. Strategic thinker with potential for advancement as the Company grows. Willingness to travel extensively in the USA, as needed. Computer skills: word processing, spreadsheets, databases, familiarity and use of

Internet/World Wide Web, presentation development skills à MS Office expertise must be at a very high level.

Writing skills: memos, letters, data analyses, with proper grammar and spelling. The competitive candidate will be a great writer and tireless reviewer with a sharp eye for language.

Demonstrated ability to manage multiple, simultaneous, complex tasks and to meet deadlines.

A positive mental attitude to daily tasks; a net contributor to overall morale.

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A demonstrated willingness to exercise initiative in cases where decisions need to be made and supervisors are not available to consult, coupled with the tact and judgment to do so appropriately.

Demonstrated communication skills, presentation skills, verbal, tact, composure and confidentiality in order to coordinate complex personnel issues, schedules, travel, and logistical projects & programs in and outside of GHI.

BA or BS required. Advanced degree strongly preferred (MS, MBA, PhD, MD, RN, PharmD) or equivalent experience

Minimum of 10 years of progressively responsible management experience in marketing or new product planning with a strong track record of success and accessible references. Field sales experience in oncology is a significant benefit.

Able to integrate and apply feedback in a professional manner. Able to prioritize and drive to results with a high emphasis on quality. Ability to build collaborative, effective cross-functional partnerships and influence across

the organization. Demonstrated ability to work with executives in Research, Development, Commercial

and Medical Affairs. Additional Information Posted:July 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Biotechnology Employer Job ID:3103 Job ID:6509720 Veteran Commitment

*********************************************************************** Apply on company website Senior Medical Director, Clinical Science BioMarin - San Francisco Bay Area Job Description BioMarin Pharmaceutical seeks a medically-trained clinical scientist with expertise in clinical research and drug development to join a multidisciplinary team involved in development of novel therapeutics for rare/orphan diseases. The candidate should be proficient in clinical study design, and execution and analysis of results. Experience interacting with clinical investigators, FDA and other regulatory authorities is highly desired. RESPONSIBILITIES 1. Hands-on participation in the clinical trial development process - conceive and execute clinical strategy and provide clinical expertise in all phases of development from pre-IND to Phase 4 2. Lead preparation of clinical sections of all relevant regulatory filings (BLA, EU Marketing application, IND, study reports, NDA, etc) 3. Participate in management of studies and serve as expert on clinical and medical issues to internal colleagues and study site staff 4. Take leadership role in review and analysis of study data and writing of study reports (CSRs) 5. Lead preparation of responses to regulatory agency queries (RTQ) and participate in FDA pre-marketing authorization meetings, EMA Scientific Advice meetings and other regulatory

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agency meetings 6. Attend and provide clinical/scientific support for investigator and consultant meetings 7. Assist in writing and preparing publications, abstracts and presentations 8. Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan 9. Serve as medical/scientific resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources 10. Interact in collaborations with strategic partners 11. Represent the company at scientific, commercial and financial community meetings and presentations 12. Serve as the Medical Monitor and Leader for clinical trials 13. Provide input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design 14. Contribute to planning and compliance with inspection readiness 15. Support business development activities, including due diligence activities 16. Interact with research/discovery to review and identify lead candidate molecules for Clinical Development To apply: http://tinyurl.com/mym7ex6 Desired Skills & Experience EDUCATION MD or MD/PhD Post-graduate training/experience essential (i.e., U.S. internship/residency, (board-eligible as a minimum), or fellowship,) EXPERIENCE 1. For appointment at the Senior Medical Director level a minimum of 7 years experience in the pharmaceutical/Biotech industry is required 2. For appointment at the Medical Director level; 5+ years experience in clinical functions in pharmaceutical or biotech industries. 4. Knowledgeable and current in GCP guidelines in US and Europe 5. Be well connected within the medical and scientific community and have a proven successful track record in management of clinical trials 6. Outstanding leadership, team, presentation, written and oral skills required 7. Collaborative and flexible in personal interactions at all levels of the company 8. Ability to work proactively and effectively, with exceptional creative problem solving skills 9. Works well with project teams and the respective functions, in particular Regulatory Affairs, Clinical Operations, Biometrics, but also Project Management, Research, Clinical Pharmacology and Commercial. 10. A strong interest in rare diseases that frequently requires creative thinking with regards to study design, endpoint selection or data analysis. 11. Experience in one or the following therapeutic areas would be considered advantageous: endocrinology, neurology, pediatrics, allergy/immunology To apply: http://tinyurl.com/mym7ex6 Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the

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treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. Additional Information Posted:August 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Biotechnology, Pharmaceuticals Employer Job ID:13-0197 Job ID:6679545 ******************************************************************* Apply on company website Senior Product Manager / Product Manager, Nephrology Marketing Questcor Pharmaceuticals, Inc. - US-CA-Hayward (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager / Product Manager, Nephrology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. Responsibilities:

Work cross-functionally with commercial team members (marketing, sales, analytics, reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of Nephrology business goals;

Manage ad agency and other vendors in development of materials and tactics; Manage national conference planning and execution; Develop strong relationships with physician leaders and contribute to advisory board

planning; Develop and implement best-in-class speaker programs to support field sales efforts; Effectively interact with sales force and handle field requests; Provide input to development and implementation of annual product marketing plans;

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Manage allotted budget at or below plan while maximizing effectiveness of resources and funds;

Overnight travel as required (~25-30%). Qualifications:

Minimum of 4 years of bio/pharmaceutical brand management including experience working on projects that involved developing promotional materials and working with opinion leaders (required);

Two years successful experience in pharmaceutical sales (preferred); Strong ability to manage multiple projects simultaneously and work independently when

appropriate; Excellent leadership, teamwork, communication and relationship-building skills; Strong project management and communications skills; Bachelor’s degree (required).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits. Questcor is an Equal Opportunity Employer. Additional Information Posted:July 29, 2013 Type:Full-time Experience:Not Applicable Functions:Advertising, Marketing, Product Management Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1265 Job ID:5945978 ***************************************************************** Apply on company website Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing Questcor Pharmaceuticals, Inc.- US-CA-Hayward (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing

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under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. The successful candidate will be responsible for developing and executing in-line product marketing efforts for Questcor’s key promoted product ACTHAR in DM/PM under the direction and leadership of the Director, DM/PM Rheumatology Marketing. The candidate will work with field sales, vendors and ACTHAR team members to develop and execute highly effective, results-driven marketing initiatives to maximize product opportunities and revenues in DM/PM. This position is located at Questcor’s corporate office in Hayward, CA. Responsibilities:

Work cross-functionally with commercial team members (marketing, sales, analytics, reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of business goals.

Manage ad agency and other vendors in development of materials and tactics. Develop strong relationships with key opinion and physician advisory board members. Develop and implement best-in-class speaker programs to support field sales efforts. Effectively interact with sales force and handle Rheumatology field requests. Contribute to the development and implementation of annual product marketing plans. Manage allotted budget at or below plan while maximizing effectiveness of resources

and funds. Qualifications:

Bachelor degree required, MBA degree preferred. Minimum of 3 years of bio/pharmaceutical brand management responsibility including

experience working on projects that involved developing promotional materials and working with Key Opinion Leaders.

Minimum of 2 years successful experience in pharmaceutical sales (preferred) Strong ability to manage multiple projects simultaneously and work independently when

appropriate. Excellent leadership, teamwork, communication and relationship-building skills. Strong project management and communications skills. Rheumatology Experience Preferred. Overnight travel as required (25-30%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:July 31, 2013 Type:Full-time Experience:Not Applicable Functions:Advertising, Marketing, Product Management Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1460 Job ID:6642919

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***************************************************************** Apply on company website Acthar Specialist, Rheumatology Questcor Pharmaceuticals, Inc.- US-CA-San Francisco (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Acthar Specialist, Rheumatology. Responsibilities: The successful candidate will be able to show documented success as a top producer. They will effectively manage their territory as a results-oriented sales person, business partner and consultant. They will develop strategically targeted, accounts and specific business plans that reflect an in-depth understanding of local, regional and national market forces impacting product sales. The incumbent will skillfully deal with the concepts and complexities associated with the products and adjunctive therapies and must demonstrate an in-depth understanding of the clinical data. Qualifications:

Bachelor degree and/or 3-5 years pharmaceutical sales experience; Rheumatology experience required; Local travel; some overnight required (10-20%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:August 14, 2013 Type:Full-time Experience:Not Applicable Functions:Sales, Business Development, Marketing Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1326 Job ID:6492867 ***************************************************************** Apply on company website

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Acthar Specialist, Rheumatology Questcor Pharmaceuticals, Inc. - US-AL-Mobile (Mobile, Alabama Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Acthar Specialist, Rheumatology. Responsibilities: The successful candidate will be able to show documented success as a top producer. They will effectively manage their territory as a results-oriented sales person, business partner and consultant. They will develop strategically targeted, accounts and specific business plans that reflect an in-depth understanding of local, regional and national market forces impacting product sales. The incumbent will skillfully deal with the concepts and complexities associated with the products and adjunctive therapies and must demonstrate an in-depth understanding of the clinical data. Qualifications:

Bachelor degree and/or 3-5 years pharmaceutical sales experience; Rheumatology experience required; Local travel; some overnight required (10-20%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:July 26, 2013 Type:Full-time Experience:Not Applicable Functions:Sales, Business Development, Marketing Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1493 Job ID:6592302 ********************************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=6635367&trk=rj_em&fromEmail=&ut=1WC8hb6A3A8BU1 Clinical Science Manager (Pacific Northwest) Synageva BioPharma Corp.- San Francisco Bay Area Job Description

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JOB TITLE Clinical Science Manager DATE AVAILABLE Immediately LOCATION United States (Pacific Northwest) Responsibilities Lead and manage the development and execution of market development objectives, strategies, tactics, and action plans to ensure the short- and long-term growth and success of Synageva in the Pacific Northwest.

Ensure achievement of the following three key imperatives and performance measures: o Increase disease awareness with key audiences. o Identify patients and assist in bringing them on to therapy, initially in clinical

trials prior to marketing authorization. o Establish a key opinion leader (KOL) network.

Establish and coordinate a health care partnership with the patient at the center surrounded by relevant stakeholders such as:

o Patient families. o Patient advocacy associations. o KOLs. o Treating physicians and other caregivers.

Lead by example to ensure effective and cooperative cross-functional physician and patient outreach efforts.

Demonstrate and instill a burning sense of urgency, humility, and passion to find and treat patients.

Communicate effectively with all levels of Synageva staff and management. Participate in strategy development, assessing trade-offs between initiatives and

priorities, followed by implementing final decisions Desired Skills & Experience

A bachelor’s degree or credentialing in a relevant discipline. A graduate degree is advantageous but not essential. A good knowledge of US markets and medical communities. A minimum of five years commercial experience interacting with medical doctors. Relevant experience in the rare diseases space encompassing patient identification and

treatment; interactions with patient advocacy associations; establishment of KOL networks; and achievement of market access is highly desirable but not essential.

Strong oral and written communication skills Demonstrable ability to collaboratively work as a team player in a dynamic and fast

moving organization. The following personal characteristics:

o A bias towards action combined with high ethical standards. o A self-starter combined with a high energy level. o Self-confidence combined with humility in approach. o Compassion and passion for patients. o An ability and willingness to take controlled risks. o A willingness and desire to be a team player

States included in the Pacific Northwest Territory are: Northern California, Washington, Oregon, Northern Nevada, Idaho, Wyoming and Montana.

Strong preference for person to have home base in San Francisco/ Bay Area. Ability to travel: 50-60% of the time.

Company Description Synageva BioPharma is a biopharmaceutical company with headquarters, research and development facilities in Lexington, MA. Synageva was formed to focus on novel orphan

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treatments for rare diseases. Our lead program, sebelipase alfa, is a recombinant human LAL (rhLAL), an enzyme replacement therapy for LAL Deficiency. Sebelipase alfa is currently in global clinical development and has been granted orphan designations by the US Food and Drug Administration ("FDA"), the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received fast track designation by the FDA and Breakthrough Therapy designation by the FDA for early onset LAL Deficiency. LAL Deficiency is a rare, serious and devastating lysosomal storage disorder (LSD) that results in significant morbidity and mortality. Synageva has four additional orphan products in development. To ensure that these therapeutic candidates reach patients in need, Synageva has recruited a team with a proven record of discovery, development and commercial experience within rare diseases. Synageva BioPharma Corp. Additional Information Posted:July 30, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Job ID:6635367 **************************************************************** Apply on company website Clinical Science Specialist Genentech - US - California,South San Francisco (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Job Description (gRED ECD Onc Clinical Science Specialist [E4a]) Genentech is seeking a Clinical Science Specialist (CSS) with clinical and drug development experience in oncology to join the Genentech Research and Early Clinical Development (gRED) Oncology ECD organization and support Clinical Science deliverables for clinical trials and programs associated with the exploratory clinical development of novel anti-cancer agents within the Genentech portfolio. These programs span first-in-human Phase I studies through proof-of-concept Phase II studies in a variety of malignant disorders, and may involve collaborations with other Clinical Development teams at Genentech, corporate development partners, and external scientific/academic/clinical organizations. The optimal candidate will have the desire to proactively participate within a multi-disciplinary team of internal clinical and commercial colleagues and have the ability to interact with external experts and investigators. Job Duties and Responsibilities:

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Scientific Writing

Draft Strategic Context Documents (SCD), Clinical Protocols, and Investigator Brochures, and coordinate the successful completion of documents with medical editing.

Conduct literature searches, draft abstracts, draft safety narratives, draft background sections of clinical documents, and ensure that standardized disease/molecule protocol language is incorporated (e.g., eligibility, dose-modification criteria, risk language, key scientific statements). Track items for inclusion in protocols and ICF amendments and work with Medical Editing to ensure the completion of the protocol and any subsequent amendments.

Functional Activities

Serve as a Clinical Science representative on cross-functional teams as assigned (i.e., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives).

Identify and implement processes to share clinical information across teams/molecules/indications.

Develop study-specific listings with data management representatives and conduct frequent clinical data listing reviews.

Working closely with the gRED medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions. .

Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan.

In conjunction with a Medical Director, create and or review clinical slides for internal and external meetings (i.e. Investigator meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). Develop and QC data tables with biostatisticians to support these activities.

Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).

In conjunction with Biostats and Medical Director review appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.).

As assigned, participate in development of the long-range strategic plans for the assigned program(s).

As assigned, participate in Clinical Science assessment of in-licensing opportunities. As assigned, mentor and/or train new Clinical Science Specialists

Who You Are Experience

Candidates should have an advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.).

6 or more years of industry/related experience (a focus on cancer cell biology or drug development is preferred).

4 or more years of clinical trial experience in industry 2 or more years of experience in, and appropriate therapeutic knowledge of, oncology Extensive knowledge of clinical research & successfully worked across Phase I – II drug

development projects Experience working on cross-functional teams Experience authoring a full clinical trial protocol (Ph I or II) Broad experience in the principles and techniques of data analysis, interpretation and

clinical relevance Comprehensive understanding of product and safety profiles Well-versed in medical aspects of GCP, ICH, FDA, EMEA, NICE and other relevant

guidelines

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Preferred: Experience publishing clinical trial results in refereed journals The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. Additional Information Posted:July 29, 2013 Type:Full-time Experience:Associate Functions:Research, Science Industries:Biotechnology, Pharmaceuticals Employer Job ID:00412468 Job ID:6283799 ********************************************************************** If you are qualified and interested please contact me privately at [email protected] Dave Murphy The Alpine Group www.alpinesearch.net Sr. Marketing Manager - Molecular Diagnostics, Bay Area To view a brief video about this opportunity please click here: http://youtu.be/DSQ-H_2BiJg A midsize Biotech client of mine has asked me to help them fill a new Sr Marketing Manager role in the infectious disease segment of the Molecular Dx market. This will be a mixed role of upstream and downstream marketing on a global basis, in a company that has grown revenue 20% per year for the fast four years. The level is a step up from Sr PM, but does not yet have any direct reports. Qualifications: - 5+ years of marketing experience in the clinical diagnostics industry, or a combination of diagnostics and pharmaceuticals - Specific marketing experience in Infectious Disease or Virology - Account Management, Sales, or Sales Support experience *********************************************************************** Please send your resume to: [email protected] Urgent: Assistant Director Trainee, HLA (Greater Los Angeles Area) - Fulltime position Position Summary and Key Responsibilities The Assistant Director Trainee will be responsible for the clinical research and development in transplant immunology and to support the clinical laboratory services under the direction of the laboratory director so that high quality and state-of-the-art laboratory testing and services are achieved. Responsibilities will include:Clinical Research and Development: Create projects, design experiments, write protocols for IRB approval and manuscripts for publication, and validate new clinical testing techniques as well as Clinical Laboratory Business: Provide advice to transplant physicians, unrelated donor search coordinators, and other clinicians; review the results of clinical testing in the absence of the lab director and supervisor; investigate result discrepancies between our reports and NMDP records. Desired Skills & Experience • Minimum Education: Doctoral Degree • Req. Certification/Licensure: Certificate from related professional societies and CA licensure

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__________________________________________________________________ Urgent: Director, Clinical Molecular Diagnostic Laboratory (Greater Los Angeles Area) - fulltime Desired Skills & Experience Minimum Education: M.D. and/or Ph.D. required Ideally Ph.D should be a Clinical Molecular Geneticist Must be boarded by the American Board of Medical Genetics in clinical genetics and hold a State of California Clinical Molecular Biologist Director license. Prior fellowship in Molecular Genetics or Pathology preferred Minimum Experience: 3 years experience as a laboratory Director or Co-Director. Skills Required for Consideration: Excellent interpersonal and management skills, including proven management, presentation, negotiation, team facilitation, and written communication. Thorough knowledge of Human Genome Variation Society (HGVS) Nomenclature guidelines and excellent detail-oriented work habits. Thorough knowledge of State, CAP, JCAHO, and institutional policies and procedures for directing a clinical laboratory. Possess knowledge of institutional and regulatory policies, technical procedures, project and time management aspects of new test development, and institutional (cancer center) best practices. Must have ability to provide objective input on operational issues, be able to lead large, complex, multidisciplinary projects and have an understanding of a broad set of problem-solving methods. Must be able to interact with a variety of personnel at various levels within and outside the organization. Must be able to evaluate and troubleshoot next generation sequencing technologies and perform appropriate computational and statistical analyses of the data, as well as meet regulatory requirements necessary for this testing. Please send your CV to [email protected] *************************************************************** Apply on company website Technical Business Development Director – Biologics Ajinomoto Althea, Inc. - Greater San Diego Area Job Description Be part of a growing and innovative organization! Ajinomoto Althea has an opportunity for a Technical Business Development Director – Biologics. As part of the field sales team, this position will be responsible to drive the sales goals and objectives globally for the Biologic Business Unit. This position will be the liaison between the field business development team and operations to facilitate all biologic opportunities within the organization. This position will work with Marketing to drive lead generation, opportunity creation, promotional activity and trade shows to create more brand recognition Responsibilities:

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Works along with VP of Sales to establish the overall sales strategy for the Biologic Manufacturing Group.

Works with the Business Development team, to develop relationships with clients to understand key applications and generate customer driven product requirements.

Achieve or exceed sales goals and objectives by actively selling to clients in the field. Frequent travel with the BD team will be required to visit customers in person. Develop a working knowledge of current and potential activities that may affect revenues.

Develop proposals on prospective opportunities for BD team. Working with Marketing, create a Biologic marketing plan that includes targeted lead

generation, promotional activities, industry events, poster and speaking presentations, and web presence.

Presents sales presentations for internal and external customers. Assists the VP of Sales with product trending and industry/market trending and may

routinely gather account and client information. Interfaces with quality systems, manufacturing and quality management personnel on

issues related to products in the field. Utilizes the CRM database to input and provide information that will increase

effectiveness and aid sales. Stays current on developments within the industry. Attends tradeshows. Utilizes technical expertise and expanding customer relationships to identify areas of

improvement and new product opportunities. Responsible for exhibiting professional behavior with both internal and external

business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Desired Skills & Experience Requirements:

Ph.D. preferred or an advanced degree in a life sciences field. Three plus (3+) years’ direct, relevant experience in sales/business development. It is

highly preferred that the candidate have up to 10 years of experience either in business development or manufacturing

Previous work experience with a Contract Manufacturing Organization or with the development, manufacturing or analytical testing of sterile biotechnology products is required.

Minimum of ten (10) years relevant experience in laboratory/manufacturing experience, including process development, optimization, scale-up, cGMP.

Analytical development experience preferred. Proven ability to build key customer relationships with the ability to educate and

demonstrate technical value propositions in order to promote the Althea difference and possess an outstanding drive for excellence and results.

High aptitude to learn technical and scientific information. Detail oriented with strong written and verbal communication skills. Must be familiar with Microsoft Office applications

Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements. If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section. Althea is an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply. Company Description

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Formerly Althea Technologies, Ajinomoto Althea is a San Diego-based biologics CDMO partner that provides clinical/commercial product development services, including production of microbial-derived recombinant proteins and plasmid DNA and cGMP filling in vials/syringes. Ajinomoto Althea also offers process development, analytical development, complex formulation, release testing, and stability testing services. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex™. Corynex™ can deliver simplified production with better results. Learn more at www.altheatech.com. Additional Information Posted:August 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Business Development Industries:Biotechnology Job ID:6807180 __________________________________________________________ VP, Biologics Manufacturing Ajinomoto Althea, Inc.- Greater San Diego Area Job Description Be part of a growing and innovative organization! Ajinomoto Althea has an opportunity for a senior leadership team member that will be responsible for providing company direction in the area of Biologics. This role will provide strategic vision and leadership to the department overseeing successful biologics campaigns, sales and growth. Responsibilities:

Responsible for overseeing the P&L of Biologics (operations, sales and compliance). Accountable for developing, building and executing Biologics business plan. Drives resources to address priorities, meet production schedules, maximize

productivity, reduce costs, and increase efficiencies through continuous improvement strategies.

Develops and monitors departmental budget, including setting and meeting targets. Responsible for developing and maintaining strong long term relationships with

customers. Stays abreast of developments within the field of biologics, biotechnology process

development, and manufacturing and changes in the relevant regulatory requirements. Ensures collaboration and commitment between Biologics and other departments

(Quality, Materials, Sales, Finance) in order to meet internal and external customer expectations.

Manages multi-functional teams by influencing, motivating and setting clear objectives. Develops and consistently meets production, quality, compliance, financial and EH&S

goals and objectives. Responsible for exhibiting professional behavior with both internal and external

business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Desired Skills & Experience Requirements:

Strong operational background with knowledge of bio CDMO industry Widely recognized in CDMO market and with bio pharmaceutical customers as a reliable

and strategic partner. Proven ability to create reliable long term relationships with customers. Documented track record of successfully engaging and securing new clients and

executing manufacturing programs in a multi-product facility. Experience with all phases of clinical trials and commercial manufacturing preferred.

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Proven understanding in the design and operation of fermentation/purification processing, and cGMP manufacturing operation requirements.

Minimum of twelve (12) years of experience in biopharmaceutical industry with strong operation background.

Minimum of six (6) years of progressive leadership experience. CMO business management experience strongly preferred. Must possess a broad knowledge of biopharmaceutical manufacturing and operations. Balance of strategic thinking and strong analytical skills with ability to execute. Advanced degree (Ph.D) strongly preferred, bachelor’s degree in a Life Sciences

discipline or equivalent required. Detail oriented and results driven with strong written, verbal communication and

presentation skills. Must be familiar with Microsoft Office applications.

Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements. If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section. Althea is an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply. Company Description Formerly Althea Technologies, Ajinomoto Althea is a San Diego-based biologics CDMO partner that provides clinical/commercial product development services, including production of microbial-derived recombinant proteins and plasmid DNA and cGMP filling in vials/syringes. Ajinomoto Althea also offers process development, analytical development, complex formulation, release testing, and stability testing services. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex™. Corynex™ can deliver simplified production with better results. Learn more at www.altheatech.com. Additional Information Posted:August 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Manufacturing Industries:Biotechnology Job ID:6807149 ****************************************************************** To apply for this temporary assignment, please include your name and this position title in the subject line of your email, and send your resume to: [email protected]. For further information about Igenica, please visit our website at www.igenica.com. Igenica, Inc. is a biopharmaceutical company focused on the creation of breakthrough antibody-based therapeutics to address the unmet medical needs of cancer patients. The company has developed innovative technology platforms for discovering novel tumor antigens and cancer antibodies and is supported by world-renowned scientific

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experts and advisors. Igenica has long term funding, and is currently expanding its research and development operations. Igenica is based in the San Francisco Bay Area. We are presently seeking to fill the following position:

Research Associate (In Vivo Biology) (Three Month Assignment)

There is an opening for a temporary position for a highly motivated in vivo biologist to support our core drug discovery activities for the development of novel cancer antibody therapeutics. The successful candidate will implement and conduct in vivo immunization studies in rodents for profiling the immunological effects of novel cancer targets. This position requires a BS/MS in Biology or equivalent discipline with several years of relevant experience. Excellent hands-on in vivo skills are mandatory. Proficiency with modes of animal dosing (IP, IV, SQ and ID) is required. Tissue sample analysis using standard molecular, cellular and biochemical techniques such as FACS and ELISA is desired. Cell culture experience is also desired. Candidates must be able to work independently and document, analyze, interpret and present results within a multidisciplinary team environment. Additionally, they should have demonstrated excellent communication, organizational and multi-tasking skills, be a team player, and have familiarity with basic methods of statistical analysis. ****************************************************************** Director Sales Compensation – CCP Required - 74473 http://www.linkedin.com/jobs?viewJob=&jobId=6623784&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=1Qh_JFSFdc7lU1 McKesson- San Francisco (San Francisco Bay Area) Job Description Director Sales Compensation – CCP Required Job ID 74473 San Francisco POSITION OVERVIEW Responsible for the development, implementation, analysis and maintenance of the company's sales compensation programs. Works with sales management to create and execute the strategic vision for the sales compensation programs. Calculate and pay incentives on a quarterly basis. Provide and communicate sales effectiveness metrics to senior management on a regular basis. RESPONSIBILITIES

Lead cross-functional sales compensation planning team. Model compensation incentives and earnings scenarios based on the company’s strategic business objectives and the financial forecast. Partner with business/functional areas to drive key strategic initiatives around sales incentive compensation and improve current process and procedures.

Administer, calculate and pay commissions on a quarterly basis. Provide direction, coaching and development of sales compensation analyst in his/her

various responsibilities in support of sales compensation function. Assess effectiveness of sales compensation plan incentives by analyzing plan results,

such as earnings vs. target plans, quota attainment distribution, pay to performance relationships, etc. and determine whether alternative incentives are needed to drive behavior in support of strategic objectives. Provide recommendations on total comp/mix based on market, internal equity, and business goals. Perform other ad hoc analysis and projects as needed.

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Partner with Finance and Sales Effectiveness in the compilation of sales force performance metrics. Prepare presentations for senior management and manage the approval process for sales compensation plans.

Design and execute against annual sales award program for top performers in the organization.

Provide consultation to senior management regarding proposed SPIFFs/incentives and administer SPIFFs/incentives.

Modify sales plan documents as needed. Coordinate publication of the documents with the sales force. Advise Human Resources, Finance and the Commission administration group with respect to interpretation and administration of the sales compensation plan. Work with HR, Legal, and Compliance on key terms/conditions and final approvals. Maintain a working knowledge of federal and state legislation which may affect compensation policies.

Desired Skills & Experience QUALIFICATIONS / MINIMUM REQUIREMENTS Education/Training: 4-year degree in HR, Business, or related field or equivalent experience Business Experience: 8+ years compensation experience including 3+ years managerial experience Specialized Knowledge/Skills

Excellent management, communication and analytical skills nowledge of state and federal laws pertaining to compensation Must have sales compensation experience Must be a strategic thinker as well tactical (actual calculations). Must be able to design and develop sales compensation programs that maximize the

ability across the organization Must be able to understand a very complex organization with multiple IC plans. CCP (Certified Compensation Professional) required CSCP (Certified Supply Chain Professional) desired

Company Description ABOUT McKESSON Making a difference starts with you. It can be as simple as helping a customer or as complex as creating lifesaving technology. When you work with McKesson, you initiate a chain of events that results in millions of people getting more from their healthcare. As the nation’s leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower all 32,000 of our employees through a collaborative environment that supports employee network groups and diversity councils. In our inclusive community, opportunity and responsibility grow. At McKesson, we believe we can empower healthcare. And it all starts with you. APPLY TODAY Please apply via this website, via our website at www.McKesson.com/careers or send your resume directly to [email protected]. Additional Information Posted:August 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Hospital & Health Care Employer Job ID:Job ID 74473 Job ID:6623784 ********************************************************************* Posted by Connie Hampton

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http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=265520334&gid=4700652&trk=eml-anet_dig-b_nd-pst_ttle-cn&fromEmail=&ut=3PTLusMSkH7lU1 Searching for a Sr. Manager of Process Development and a Director of Process R&D (drug product) for a company in Emeryville, CA. We really need people who understand wurster fluid bed coating for extended release capsules. Know anyone? ********************************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=6840359&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=2t-Wlty4wy7lU1 Quality Manager National Staffing Consultants- Fremont, CA (San Francisco Bay Area) Job Description Quality Manager ~ Fremont CA Area ~ NEW & EXCITING POSITION! We are searching for a Quality Manager for our client just north of the Fremont, CA Area. This role requires a strong background in Quality Management Systems with a track record of success in quality improvements. Please note that relocation assistance is NOT being offered for this role. Brief Overview: The Quality Manager will be accountable for the development, implementation and maintenance of systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. This position is a hands-on role and would oversee three small sites. Desired Skills & Experience Requirements:

Bachelor's degree in a scientific discipline or related discipline. Master's degree in a scientific discipline or related discipline desired but not required.

6-8+ years of successful experience in a senior level Quality Manager capacity. Life science industry is preferred. Will consider industry experience in

Telecommunications or Electronics. Demonstrated experience working in a highly matrixed organization, preferably in a

manufacturing setting. Certifications preferred: American Society of Quality Certified Quality Manager (C.Q.M). Requires prior managerial experience. Knowledge of FDA practices and guidelines. Knowledge of pharma/biotech bulk and finished product manufacturing and analytical

testing requirements. Knowledge of analytical instrumentation and software, and medical devices. Knowledge of ISO 9001, ISO 13485, cGMP and QSR. Experience bringing a site to being 9001 certified is a plus!

Please note we have multiple roles open in this area that vary in scope. Contact us today to learn more. Email : [email protected] Company Description National Staffing Consultants is a National Search Firm Serving the Life Sciences Industry. “You have the best recruiters I’ve ever worked with.” At National Staffing Consultants, we hear this compliment time again from our clients and candidates. So what makes us different from other search firms? As a boutique executive recruiting firm, we focus on job recruitment for the Biotechnology, Medical Device, and Pharmaceutical industries in Greater Boston, MA, New England, and throughout the U.S.

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We bring PASSION, DEDICATION and COMMITTMENT to our work. We delive at nothing less than 100% and have 20 years of proven success. See for yourself what clients and candidates have to say about working with the recruitment team at National Staffing Consultants. Contact us today! http://www.national-staff.com/contact-us.html OR http://[email protected] National Staffing ConsultantsAdditional Information Posted:August 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Quality Assurance Industries:Pharmaceuticals, Medical Devices, Biotechnology Compensation:Salary + Bonus Referral Bonus:Referral Bonus Yes Job ID:6840359 ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=F5F2C55B-59A7-4026-83B3-21D6464C0618&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Senior Regulatory Affairs Manager Actelion Pharmaceutical US, Inc Job Description JOB DETAILS The primary responsibility of the Regulatory Affairs Senior Manager is to provide regulatory expertise and guidance on Actelion advertising and promotion to ensure compliance with applicable regulations and guidance. This position is also responsible to champion the strategic development and tactical implementation of Risk Evaluation and Mitigation Strategies (REMS).

Provide regulatory expertise and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations).

Chair and represent Regulatory Affairs on the cross-functional Actelion Review Committee (ARC) for assigned product(s).

Build positive working relationship with FDA Office of Prescription Drug Promotion in support of Actelion advertising and promotion submissions and compliance.

Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotion materials to OPDP in accordance with regulations to support business objectives.

Provide strategic direction and tactical implementation of Risk Evaluation and Mitigation Strategy (REMS) program for assigned product(s).

Facilitate and lead cross-functional teams during the development, implementation and life cycle maintenance of REMS program on assigned product(s).

Responsible for preparation of complex regulatory reports and submissions supporting REMS.

Apprise management of developments and issues relating to REMS program. Develop materials and train Specialty Pharmacy partners (SPs) for Actelion marketed

products to help assure adherence to REMS requirements. Document that current SPs are appropriately trained and have completed certification requirements.

Mobilize rapid response team in South San Francisco office as necessary to address any gaps, inquiries, or compliance issues regarding REMS.

Regularly monitor the regulatory compliance and REMS trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the

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impact on the industry and the company. Communicate these insights to the Department and project teams in a timely manner.

Work with Regulatory Leadership Team to enhance systems, technology and processes. Ensure quality documents are defined, created, maintained and implemented globally in

accordance with Actelion requirements. In addition, provide local input on global SOPs as appropriate.

Other duties may be assigned. This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requirements

4-6 years experience in pharmaceutical industry with at least 4 years experience in Regulatory Affairs.

Bachelor degree in related scientific discipline preferred or equivalent experience. In-depth knowledge of regulations and their implementation with specific experience in

the area of advertising and promotion. Experience with Subpart H or Risk MAP products preferred. Experience with Risk Evaluation and Mitigation Strategy (REMS) products preferred. Experience with FDA Inspection and internal quality audits preferred. Demonstrated leadership, interpersonal and collaboration skills, and ability to interact

with management and resolve conflicts. Strong negotiation and decision making skills. Must be able to provide creative solutions to complex problems. Excellent verbal, written, communication and presentation skills. Excellent organization skills, interpersonal skills and ability to work on a number of

projects with tight timeline. The ability to effectively prioritize and triage multiple activities/projects and understand

and interpret complex policies and directions. High degree of personal integrity and ethics.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk and hear. The employee is required to frequently operate a personal computer and occasionally move about the facility. The employee must occasionally lift and/or move up to 15 pounds. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate. ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=E5B7970B-E79F-44C0-9A87-C1BC8ABC26F1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 HEALTH CARE COMPLIANCE OFFICER Johnson & Johnson Job Description HEALTH CARE COMPLIANCE OFFICER (Job Number:0591130616)

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Description: Johnson & Johnson is looking for an HCC Officer for Acclarent Inc located in Menlo Park, California and Cordis Corporation located in Fremont California. The companies are part of the Johnson & Johnson family of companies in the Medical Device sector. This Officer position will provide HCC support and oversight for both companies. Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. Acclarent is a medical technology company dedicated to designing, developing and commercializing technologies that address conditions affecting the ear, nose and throat. The company was founded in 2004, was acquired by J&J in 2010. It is a growing company currently with about 350 employees, a US sales organization of about 150, and worldwide sales of approximately $200MM. Cordis Corporation is relocating the company's headquarters to Fremont, California. Cordis is a pioneer in less invasive treatments for vascular disease specializing in interventional medical procedures in cardiovascular, endovascular, and biliary duct (liver) treatments. Cordis sales are approximately $840MM worldwide with about 700 employees and a US sales organization of 225 people. As HCCO, the person in this position will serve as the HCC Officer for both Acclarent and Cordis providing support for the management boards, chairing its HCC Committees, and providing compliance support for key headquarters functions. HCC officers implement and maintain programs that support compliance with HCC laws, regulations and industry standards related to the promotion and marketing of health care products and services, interactions with health care professionals and/or government officials, including, as applicable to the business activities, FCPA and other anti-corruption laws, off-label promotion, anti-kickback and false claims statutes, compliance with corporate integrity agreements, deferred prosecution agreements or other settlements. The HCCO partners with company leadership (sales, marketing, R&D, HR, etc.,) to implement and maintain that Health Care Compliance programs that prevent and/or detect violations of law, regulations, and company policies. He/she will be acting as a consultant, reviewer and approver as needed, for business activities that involve HCC risks. This individual will be providing appropriate guidance, education, training, and regular communications on HCC to all relevant employees. He/she will support the risk assessment process, testing & monitoring efforts, external audits and reviews, corrective actions, response to reports of potential misconduct, and other elements of the companies' compliance programs. The Acclarent and Cordis HCCO will provide strategic support to senior management at the business units regarding potential compliance risks, compliance-related incidents and investigations, and trends, root causes, and recommend and implement appropriate action plans. He/she will participate in cross-company or cross-sector compliance initiatives within J&J, as necessary, and provide support to J&J HCC senior management. This individual will interface with legal counsel regarding HCC requirements and interpretation. The HCCO will partner with colleagues within the Global Surgery Group and J&J HCCP to drive the adoption of more efficient or effective HCC related practices. This individual will support the efficient implementation of the US Sunshine Act reporting obligations, and will analyze metrics at the operating company level and provide analysis to Global Surgery Group Leader and others as appropriate. The Acclarent and Cordis HCCO will manage a HCC Manager and have dotted line management of a second HCC manager who support the HCC programs at each operating company. This role includes actively engaging in the enterprise-wide Talent Management process for HCC to include establishing goals and objectives, giving direction, support, and periodic feedback to direct reports pursuant to Human Resources policies. He/she will provide technical subject matter expertise, advice and development opportunities to direct and indirect reports. Qualifications: A minimum of a Bachelors Degree is required. A minimum of 6 years of business experience, with at least five years in health care compliance, government

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contracts compliance or related compliance area is required. Current status as a Certified Compliance & Ethics Professional (CCEP®) or Certification in Healthcare Compliance (CHC®) preferred. Knowledge of healthcare fraud and abuse, anti-corruption and false claims laws is required. Knowledge of laws and regulations governing health care reimbursement is required. Knowledge of laws and regulations concerning the marketing and promotion of medical devices is required. Knowledge of financial or auditing practices is required. Knowledge of current standards and guidance concerning corporate compliance and ethics programs is required. Demonstrated experience in the development and implementation of a compliance program in accordance with the organization's risk profile is required. Exceptional written and verbal communications skills are required. Experience with project management in a matrixed business organization is preferred. Strong communication skills, organizational skills, and analytical skills are required. Broad business experience and a proven ability to influence business decisions and business partners are required. Ability to think strategically, develop and execute longer-term objectives is required. Ability to take complex business situations and develop solutions that ensure compliance is required. Proven track record in delivering results, self starter and ability to manage complexity is required. Ability to work well between functions and across all levels of the business and effective negotiating skills is required. Ability to comprehend and interpret legal documents is preferred. Proven success at managing and developing talent is required. This position will be located in Menlo Park, CA and Fremont, CA and will require up to 20% travel. Primary Location: North America-United States-California-Fremont Other Locations: Organization: Johnson & Johnson (6067) Job Function: Health Care Compliance ************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. · Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives. · Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives.

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· Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities. · Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. · May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements. ****************************************************************** For the opportunity below, please send resume to [email protected]. Software Quality Assurance Test Engineer - San Francisco, CA

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Other opportunities are posted in JOBS category at www.darshanavnadkarni.wordpress.com or at the link http://bit.ly/145kJ43 . SQA Test Engineer - SF, CA A software company that provides innovative, modular, scalable and world class solutions by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is scaling, in pre-funding stage. The company is expanding core engineering and product development team & looking for high caliber, senior, Quality Assurance Test Engineers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment. Responsibilities: Acquire in-depth understanding of the company’s products to ensure high quality of products; Support the development of workarounds, testing, necessary documentation (including investigation and resolution of issues; Assist in coordinating delivery management tasks; Track requirements and software release management for clients; Be first escalation point for supporting company’s customers. Requirements: Must have strong client support & project management background. Must have 4-6 years of implementation & post production support experience for enterprise applications; 3-4 years of functionality, testing, bug tracking, writing test cases experience; strong communication skills; demonstrable hands-on experience with quality management tools; technical skills in SQL, HTML based documentation. Highly preferred: skills in developing and managing on-line help content. Location: San Francisco Bay Area. Telecommuting is okay but will need to attend client team meetings – so must be in driving distance. Duration: 6-12 months, full to part-time, 1099, corp to corp, contract to hire. No visa sponsorships. *************************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6482468&trk=jobs_seeking_view_job&goback=%2Evjs_6860208_*2_*2_*2_false_*2_*2 Pricing Analyst Karl Storz Endoscopy - Greater Los Angeles Area Job Description 2+ of Financial Analysis Consulting experience preferably from a big 4 consulting company. The Pricing Analyst is responsible for supporting the Pricing Director and Pricing Office team in the achievement of KSEA’s pricing strategies. Responsibilities: • Creates, maintains and advances a robust analytic and reporting platform for KSEA product pricing, market pricing, competitor data, market share and other relevant competitive market data • Support KSEA’s needs for reporting, scoreboards, and ad hoc analyses that provide transparency around KSEA’s pricing realization trends as well as market pricing trends • Interface with Sales management, either directly or indirectly, when requests for exception pricing are submitted to the Pricing Office • Develop personal expertise in KARL STORZ products, classifications of products, and the relative position of those products compared to competitors' products • Support KSEA marketing teams throughout the year and during pricing update exercises • Update data tables with new sales and product data on a monthly basis • Support related KSEA functional groups that also provide analytics and reporting: Financial Planning and Analysis group and the Business Planning group Professional competence:

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• Knowledge and use of tools, Access, Excel, PowerPoint etc. o Is expert at identifying, extracting and modeling relevant data to solve target solutions o Structures models independently o Develops slides independently • Working structured and analytical o Analyzes data in a structured approach with some up-front guidance o Interprets data correctly o Delivers accurate output o Develops alternative solutions and develops outside-the-box ideas • Makes efficient use of resources o Involves manager and team adequately o Makes use of and contributes to knowledge management o Uses own time efficiently o Identifies sources to acquire the know-how necessary o Seeks and identifies improvement potential within range of own tasks • Presentations: o Is able to present prepared findings to the team o Is able to answer specific questions within his area of responsibility o Manages/moderates a normal meeting or parts of a workshop with assistance • Identify and consider client agenda o Immediately understands problems of the client if they are addressed • Building and cultivating personal relationships o Is recognized by the client as contact person for his subjects Desired Skills & Experience Qualifications: Education Required: • Undergraduate degree in Finance, Accounting or similar • Strong technical/programming skills o Strong Access or equivalent database programming and data modeling skills o Excel modeling skills with ability to program macros using VBA code o On-going maintenance and upgrading of existing analytical tools (both Excel and Access) data architecture a plus • In depth understanding of financial data and financial statements and ability to use that knowledge to test and validate data outputs • Robust analytical skills and ability to utilize computer systems and related tools, including SAP, Microsoft Access, Excel, and Power Point • Ability to accept and execute with clear direction for on-going pricing office report distribution and communication • Excellent verbal & written skills; ability to communicate clearly with senior management Company Description The product range from KARL STORZ includes rigid and flexible endoscopes, instruments for the entire field of human medicine. Innovative products such as a fully digital video chain and KARL STORZ AIDA®, the central image and data archiving system, make for documentation that is convenient, comprehensive and high in quality. With the KARL STORZ OR1™ a visionary OR concept for minimally invasive surgery of the

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future has taken shape: it is a fully integrated OR, centrally monitored and controlled, in which surgical processes and routine work are simultaneously streamlined and simplified. KARL STORZ is an equal opportunity employer Additional Information Posted:July 18, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Medical Devices Job ID:6482468 ************************************************************************ Apply on company website Pricing Analyst NuVasive- San Diego (Greater San Diego Area) Job Description This A Player will be responsible for both pricing contracts and capital purchase quotes for hospitals in accordance with NuVasive pricing objectives, terms and conditions. - Ensure accuracy on outbound quotes and consistently meet the turn-around time promised to the sales force. - Decrease the gap between when pricing is presented to the hospital, and when it is accepted and loaded into SAP to minimize credit and re-bills. - This job requires someone who is an advanced user of Excel and has a high attention to detail. - This person must be able to multi-task in a very fast paced environment, meet deadlines, follow all steps and document all necessary information for audit purposes. - This person must be comfortable working in a growing company and be able to independently manage projects with little direction. - They need to be a self starter and someone who is constantly looking for ways to improve the process and efficiency of how things are done. Desired Skills & Experience - Follows all internal policies and procedures 100% of the time, is responsible for recording all required documentation and will help with the preparation of both internal and external audits. - Provide assistance to sales reps with strategic planning of quotes, this will require the Sales Coordinator to become an expert on all products, and different pricing strategies. - Provide analytic and operational support to sales force for standard and capital purchase quotes, for individual customer and GPO/IDN contracts and pricing strategies. Conduct other financial analysis to support pricing strategies as needed. - Support sales force with pricing strategy and rational behind corporate position to help facilitate positive outcomes in pricing discussions. - Provide sales force with reports/tools to gain visibility to open quotes in the field. - Monitor the group quotes email inbox and respond to all requests. - Responsible for coordinating multiple sales territories, must be responsive to all requests with consistent follow up and coordinate all required approvals. The Sales Coordinator will red-line RFP’s and also assist with obtaining all required documentation from the hospital. - Execute and monitor negotiated contracts from implementation to expiration and coordinate with pricing team to ensure that all accepted pricing is loaded into SAP and that any extensions or updates to the contract are updated in SAP within one day of hospital acceptance. - Support the pricing team to resolve pricing discrepancies and other related issues. Company Description NuVasive® is a medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $8.2 billion global spine market. NuVasive’s principal product offering is based on

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its Maximum Access Surgery, or MAS® platform. The MAS platform combines several categories of solutions that collectively minimize soft tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon: a proprietary software-driven nerve avoidance system and intra-operative monitoring support; MaXcess®, a unique split-blade retractor system; a wide variety of specialized implants; and several biologic products to aid in the spinal fusion process. MAS significantly reduces surgery time and returns patients to activities of daily living much faster than conventional approaches. Having redefined spine surgery with the MAS platform’s lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, NuVasive has built an entire spine franchise. With over 80 products today spanning lumbar, thoracic and cervical applications, the Company will continue to expand and evolve its offering predicated on its R&D focus and dedication to outstanding service levels supported by a culture of Absolute Responsiveness®. Additional Information Posted:August 15, 2013 Type:Full-time Experience:Mid-Senior level Functions:Analyst Industries:Medical Devices Employer Job ID:1406-151 Job ID:6860208 ******************************************************************* Contact [email protected] if interested! Be sure to visit www.biophaseinc.com to view all our latest job opportunities. Surface Chemist (Redwood City) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Surface Chemist to work for a leading Bay Area biotechnology company. Surface Chemist We are recruiting for a Surface Chemist to join our fast growing start-up client in Next Generation Sequencing technology. This position is direct-hire full time and located in Redwood City, CA. Ph.D level surface chemist with extensive experience in ligand conjugation chemistry both in solution and on solid surfaces, experience with chemical surface characterization and chemical derivatization of surfaces and soluble molecules A minimum of 5 years experience developing products or assays Thorough knowledge of the biochemistry of proteins and nucleic acids and hands-on experience working with biomolecules Experience working with biomolecules in the context of microchannels and microfluidic devices Proven ability to independently design studies, define goals, produce experimental plans, execute experiments, do in-depth data analysis and present results and conclusions for internal and external review A plus if experience with product development, process transfer, manufacturing scale-up, quality control procedures and controlled documentation processes Innovative, driven, results-oriented and methodical, with record of achievement commensurate with previous experience Leadership skills, ability to collaborate within a multidisciplinary organization and used to work within tight schedules Extensive publications Experience in product development with next generation sequencing in industry or academia.

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********************************************************************** There are 383 jobs listed at the new Bio Jobs: The Talent Hub for Biotech on the BIO website. I’ve listed the first 75 in California that were posted since August 4, 2013 to give you idea of variety. See more at: http://jobs.bio.org/jobseeker/search/results/state/California#sthash.VtzQuFQm.dpuf Scientist, Biology (Ophthalmology/Vision Science) Allergan

Irvine, California, United States 08/14/2013 Project Lead, Development Lpath, Inc.

San Diego, California, United States 08/08/2013 San Francisco, California, United States Chicago, Illinois, United States More... 08/06/2013 QA Director AmpliPhi Biosciences

San Diego, California, United States 08/06/2013 Biologist - Edwards Air Force Base, California CH2M HILL

Lancaster, California, United States 08/05/2013 Postdoctoral fellow University of California San Francisco

San Francisco, California, United States 08/04/2013 Director Assay Development HTS (1534_0010763676-01-1)

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Novartis Institute For Functional Genomics, Inc.

San Diego, California, United States 08/04/2013 Jobs from the Web Research Assistant II, Biology California Institute for Biomedical Research La Jolla, CA, US 08/06/2013 Medical Writer, Neurology Allergan, Inc. Irvine, CA, US 08/10/2013 Biologist - Edwards Air Force Base, California CH2M HILL Lancaster, CA, US 08/06/2013 Programmer / Analyst (SQL, Perl, Java, Unix) Althea Dx San Diego, CA, US 08/05/2013 CBG Associate II City Of Hope Duarte, CA, US 08/14/2013 Staff Scientist City Of Hope Duarte, CA, US 08/12/2013 Associate Director - High Throughput Screening

Calibration Technician IV - Los Angeles, CA area Tektronix

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Vertex Pharmaceuticals San Diego, CA, US 08/09/2013 Scientist Genentech South San Francisco, CA, US 08/14/2013

Regulatory Medical Writer (home based) San Francisco, CA, US 08/08/2013 Scientific Manager, BioAnalytical Sciences Genentech South San Francisco, CA, US 08/13/2013 Associate Director - High Throughput Screening San Diego, CA, US 08/10/2013

Sterilization Microbiologist - Cor-Tech LLC Temecula, CA, US 08/06/2013

Sr Mgr, HW Engineering - Healthcare Diagnostics Sacramento, CA, US 08/05/2013

Senior QC Associate

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Genentech Vacaville, CA, US 08/08/2013

Research Associate Randstad Pharma Novato, CA, US 08/05/2013

Baxter Research Associate II - Diagnostic Illumina, Inc San Diego, CA, US 08/15/2013 Sr. Manager, Biomarker Foster City, CA, US 08/08/2013 Senior Microbiologist Siemens Corporation West Sacramento, CA, US 08/13/2013 Microbiologist 2 - Clinical Affairs Siemens Corporation West Sacramento, CA, US 08/13/2013 Microbiologist 2 Siemens Corporation West Sacramento, CA, US 08/11/2013 Terrestrial Biologist Environmental Scientist

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Business Unit Marketing Manager (D13-044) Reimbursement Specialist TearLab, Inc San Diego, CA, US 08/14/2013 Director, Quality Thousand Oaks, CA, US 08/05/2013 Jobs from the Web Statistical Geneticist Focusing On Parkinson's Disease 23 and Me Mountain View, CA, US 08/10/2013 Accounts Payable Clerk TearLab San Diego, CA, US 08/15/2013 Research Associate III - Molecular Biology Fisher Scientific Los Angeles, CA, US 08/13/2013 Associate Scientist III - R&D Superior Group Carlsbad, CA, US 08/13/2013 Director Quality Baxter

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Thousand Oaks, CA, US 08/11/2013 Associate Director - Cancer Diagnostics, Center for Cancer Research SRI International Menlo Park, CA, US 08/07/2013 Document Control Coordinator TearLab San Diego, CA, US 08/15/2013 Assistant Biochemist ON-BOARD SERVICES San Diego, CA, US 08/08/2013 Accountant AltheaDx San Diego, CA, US 08/09/2013 Medical Writer- regulatory Contract through Green Key Resources San Diego, CA, US 08/07/2013 CRO Business Development Manager-US based (for Asia Pacific territory) Clinical Blend, LLC San Diego, CA, US 08/10/2013 Clinical Research Associate/Biostatistics CosignMed Fremont, CA, US

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08/10/2013 Staff Research Associate I - FT NICRE San Francisco, CA, US 08/07/2013 - See more at: http://jobs.bio.org/jobseeker/search/results/state/California#sthash.VtzQuFQm.dpuf ******************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6232334&trk=jobs_seeking_view_job&goback=%2Evjs_6827977_*2_*2_*2_false_*2_*2 Senior Clinical Trial Manager, Pharmaceutical Valesta Clinical Research Solutions- San Francisco Bay Area Job Description Senior Clinical Trial Manager, Oncology / Infectious Disease San Francisco Bay area Growing clinical stage biopharmaceutical client located in the San Francisco Bay area has an immediate need to hire a full time Senior Clinical Trial Manager. Their pipeline includes oncology and infectious disease pharmaceutical products. The Sr. Clinical Trial Manager will be responsible for overseeing multiple clinical trials including all clinical operations responsibilities (budgets, timelines, vendor selection, etc.). The Sr. Clinical Trial Manager will also provide oversight of clinical team staff during study start-up, interim monitoring and closeout activities. Desired Skills & Experience Position Requires:

Bachelor's Degree (or higher) and a minimum of 8 years of pharmaceutical industry clinical research experience with a minimum of 3 years of management level experience.

Must have experience with managing multiple clinical trials simultaneously and strong clinical operations background.

Must have prior direct report management experience and Oncology and/or Infectious disease experience.

Ability to travel up to 25% required. Company Description Valesta Clinical Research Solutions (Valesta) is a leading provider of skilled clinical research professionals at all career levels for project-based, contract-to-hire, and direct hire opportunities. Our dedicated Account Executives thoroughly understand the industries they serve and offer resourcing solutions in specialized areas, such as clinical data, clinical monitoring, medical writing, biometrics, and regulatory affairs. In 2011, Valesta joined forces with the clinical research division of On Assignment forming a partnership that strengthened our ability to offer comprehensive resourcing services to our clients for both their domestic and international locations. Valesta offices are located in Mechelen and Wavre, Belgium; Madrid and Barcelona, Spain; and Den Bosch, Netherlands; with five branch offices in the United States, including California, Connecticut, Pennsylvania, North Carolina, and Illinois. Valesta Clinical Research Solutions Additional Information Posted:August 6, 2013

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Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6232334 *********************************************************************** Posted by Lauri Loris at [email protected] http://www.linkedin.com/jobs?viewJob=&jobId=6232334&trk=jobs_seeking_view_job&goback=%2Evjs_6827977_*2_*2_*2_false_*2_*2 Senior Clinical Trial Manager, Pharmaceutical Valesta Clinical Research Solutions- San Francisco Bay Area Job Description Senior Clinical Trial Manager, Oncology / Infectious Disease San Francisco Bay area Growing clinical stage biopharmaceutical client located in the San Francisco Bay area has an immediate need to hire a full time Senior Clinical Trial Manager. Their pipeline includes oncology and infectious disease pharmaceutical products. The Sr. Clinical Trial Manager will be responsible for overseeing multiple clinical trials including all clinical operations responsibilities (budgets, timelines, vendor selection, etc.). The Sr. Clinical Trial Manager will also provide oversight of clinical team staff during study start-up, interim monitoring and closeout activities. Desired Skills & Experience Position Requires:

Bachelor's Degree (or higher) and a minimum of 8 years of pharmaceutical industry clinical research experience with a minimum of 3 years of management level experience.

Must have experience with managing multiple clinical trials simultaneously and strong clinical operations background.

Must have prior direct report management experience and Oncology and/or Infectious disease experience.

Ability to travel up to 25% required. Company Description Valesta Clinical Research Solutions (Valesta) is a leading provider of skilled clinical research professionals at all career levels for project-based, contract-to-hire, and direct hire opportunities. Our dedicated Account Executives thoroughly understand the industries they serve and offer resourcing solutions in specialized areas, such as clinical data, clinical monitoring, medical writing, biometrics, and regulatory affairs. In 2011, Valesta joined forces with the clinical research division of On Assignment forming a partnership that strengthened our ability to offer comprehensive resourcing services to our clients for both their domestic and international locations. Valesta offices are located in Mechelen and Wavre, Belgium; Madrid and Barcelona, Spain; and Den Bosch, Netherlands; with five branch offices in the United States, including California, Connecticut, Pennsylvania, North Carolina, and Illinois. Valesta Clinical Research SolutionsAdditional Information Posted:August 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6232334 *********************************************************************

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Senior Clinical Trial Manager InVentivHealth Clinical- South San Francisco, CA (San Francisco Bay Area) Job Description Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Company’s early development portfolio: • Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) • Develop program timelines and budgets and manage variance • Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans • Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget • Develop and present operational plan to management review bodies • Identify program risks and develop and implement mitigation strategies for assigned programs • Define the resourcing and outsourcing strategy for early development programs • Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders • Partner with Business Management to identify strategic business needs to support the clinical programs • Partner with late-stage development leaders to ensure strategic alignment on the CDP • Resource projects to enable teams to meet deliverables • Create a positive work environment by encouraging mutual respect, innovation and accountability Minimum: • 10+ years experience of clinical and drug development, including 5+ years of clinical trial management experience, with expertise in any area of Infectious Disease, Cardio, CNS, Immunology, Respiratory • 2+ years of clinical program management experience • Functional management experience preferred • Experience in early phase clinical development • Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred • Working knowledge of international regulatory and ICH GCP guidelines Experience, Skills, Knowledge: • Demonstrated understanding, knowledge, and experience of drug development with particular focus on early development • Demonstrated experience in various therapeutic areas • Strong analytical and strategic agility skills • Excellent planning and organizational skills • High level of initiative and ability to work independently • Exceptional leadership skills, including motivation and delegation Education: • Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred Desired Skills & Experience MUST have at least 5 years of experience This is a salaried position with InVentiv Health Clinical Additional Information Posted:August 13, 2013 Type:Full-time Experience:Mid-Senior level

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Functions:Other Industries:Pharmaceuticals, Biotechnology Job ID:6827977 ********************************************************************* Hiring for Entry level/Junior Pharmaceutical Sales Representative, PCP Diabetes at Northridge, CA and looking for suitable candidates. Single Click Job Sharing on Multiple Linkedin Groups with Wisestep.com. Apply Online: http://www.wisestep.com/RLFNQUQL/IRAGCIGFAI or Share with Friends. Job Description: This is a 4 yr. engagement. The primary objective of the sales representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Qualifications/Experience 4 year Bachelor degree required MUST HAVE Minimum 1 year of successful Business to Business sales experience or similar related experience (e.g. Nursing, CDE Certified Diabetes Educator, Pharmaceutical Sales, College Graduate with transferable experiences/skills) required MUST HAVE Demonstrated ability to learn and apply technical and scientific product-related information Demonstrated ability to manage territory budget Consistent track record of quantifiable/documented sales accomplishments Demonstrated ability to plan, analyze and act upon sales data within an assigned geography Solid business acumen including excellent and persuasive business communication Demonstrated ability to work independently and exercise good business judgment and discretion and to analyze and address territory opportunities and build key customer relationships Ability to travel as necessary is required Residence within the current geography is required ************************************************************************ If you are qualified and interested please contact me privately at [email protected] Dave Murphy The Alpine Group www.alpinesearch.net Director of Consumer / DTP Marketing: Southern California To view a brief video about this opportunity click here: http://youtu.be/V36dgJPAkJU A midsize client of mine in the biopharma industry has asked me to help them fill a Director of Consumer Marketing role, leading all patient and consumer marketing for two different product lines. This is a very immature market so the focus is on market development and expansion. Since there is no direct competition for their products patient education and consumer marketing will be crucial to their success, so the role will be fairly high-profile. Qualifications: - 7 years of pharmaceutical marketing experience, including product launch

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- 3+ years of Consumer / Patient Marketing in the pharma industry - Experience coordinating ad agencies, PR firms and social media programs ********************************************************************** Apply on company website Commercial Production Mngr, Drug Product @ Pharmacyclics in Sunnyvale Commercial Production Managrr, Drug Product Job Code:11-HC-1 Primarily responsible for the production of commercial drug product intended for world-wide distribution. Oversight of drug product manufacturing activities at contract manufacturing organizations. Responsibility for post-approval strategies and continued process verification activities. Represent commercial manufacturing both as part of cross-functional teams and to business partners. Key Accountabilities/Core Job Responsibilities: * Provide leadership and oversight to all aspects of the commercial production of drug product at contract manufacturing organizations (CMO) * Interact with the supply chain group at Pharmacyclics to monitor and direct the drug product production schedule in accordance with the supply forecast. * Champion improvement and optimization of the drug product manufacturing process. Develop strategies for implementation of post-approval changes in the context of world-wide regulatory considerations and with minimal impact to ongoing business strategies.. * Create and maintain manufacturing database and lead continued process verification efforts. Compile and interpret intra- and inter- batch data to assess variability and formulate strategies to minimize and improve process control. * Provide technical review of batch records and associated documents for commercial drug products manufactured at the CMO. Function as technical expert to formulate solutions to complex manufacturing issues. Collaborate with internal quality organizations to enable timely lot release and issue resolution. . * As necessary, function as Person-In-Plant to oversee GMP manufacturing operation performed at CMO site. Formulate solutions to complex manufacturing issues. Requirements Qualifications and Experience: * Experienced background in solid dosage form manufacturing processes. Experience in managing CMO’s required. * Thorough understanding of regulatory guidance as applied to solid dosage forms and post-approval changes * Relevant experience in process validation and continued process verification * Advanced data and statistical analysis skills as applied to process improvement and optimization activities. * Excellent organizational and time management skills. Team Player. * Advanced communication and technical writing skills. * Strong strategic planning ability as well as detail-oriented thinking required. * 10 + years of relevant experience in the pharmaceutical industry. Level and salary commensurate with experience. Education Requirements: * BS in an engineering or scientific discipline. **********************************************************************

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https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. · Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives. · Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives. · Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities. · Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. · May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

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Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. ******************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that

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effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can

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pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.

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As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at [email protected], phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters

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and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • [email protected] PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at [email protected].

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You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science

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careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at [email protected] if they wish to receive these mailings directly. *************************************************************************