12/14/2014 1

Jobs That Crossed My Desk Through Dec. 14, 2014 Complimentary Service of Audreysnetwork.com

Dec. 14, 2014

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. ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=0868AF58-9956-4EF7-BB1C-

0E9769AC7912&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary

Date Posted: 12/11/14 Location: Irvine, CA Senior Analyst Compliance

Edwards Lifesciences Job Description The Sr. Analyst, Compliance, will be a critical member of the Compliance Department enhancing the company’s ethics and compliance program.

Essential Job Functions Develop and update global monitoring plan; monitor compliance with U.S. policies and procedures,

including development of templates and metrics for tracking and trending, and providing appropriate guidance to internal stakeholders.

Assist in and track progress of investigations and potential violations of policies in central case management system, ensuring consistent processing, treatment and disposition.

Review and approve transactions and interactions with health care professionals. Develop and update global training plan; develop training materials, job aids and other resources

for internal stakeholders and update such resources on the intranet. Other incidental duties

Qualifications Bachelor’s degree required

Minimum of five years’ legal, internal audit, and/or health care compliance experience, ideally at a pharmaceutical or medical device company, with understanding of PhRMA or AdvaMed Code requirements a plus

Excellent organizational skills, with ability to analyze and synthesize large amounts of data Experience with systems and programs, with familiarity with J.D. Edwards and SharePoint a plus

Highly responsible, accountable, and adaptable, with the ability to simultaneously handle multiple assignments and competing priorities

Ability to work with minimal supervision and exercise independent judgment, make decisions, and give appropriate advice to internal stakeholders

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********************************************************************** http://jobs.fiercebiotech.com/job/12247409/2709 Sr. Associate Scientist/Scientist Biology Mountain View, CA (US - 94043) About the Job ChemoCentryx is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered small molecule therapeutics that target the chemokine and chemo-attractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. We are building a strong pipeline that currently includes products in development for immunological diseases, metabolic disease and cancer. At ChemoCentryx, we are committed to developing innovative therapeutics, cutting-edge technologies and pursuing the highest quality science. As a member of the molecular pharmacology group, the incumbent will be responsible for developing and performing a variety of cell-based in vitro assays supporting novel therapeutic development programs. The position requires solid cell culture skills and the ability to conduct reproducible cell-based assays.

Attention to detail, strong communication skills, and the ability to work both independently and as part of a team is essential for this position. Experience with in vivo models and/or biomarkers a plus. Minimal educational requirements include an MS degree in a biological science with 3+ years, or a BS degree with 5+ years of relevant experience. Preferred candidates will have extensive experience in Multi-

color flow cytometry. How to Apply Please email your resume & cover letter to: hiring@chemocentryx.com or fax to: (650) 210-2910. Please reference the Job Code: CCX#016.

All ChemoCentryx employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts, and a comprehensive benefits package, including medical, dental and vision coverage and life and long-term disability insurance. EOE

****************************************************************** https://jobs.smartbrief.com/action/listing?listingid=3AE14391-AC4E-4D5F-B31D-27DD0AAC608D&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary Location: South San Francisco, CA Assistant General Counsel/Senior Corporate Counsel

Genentech Job Description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the

forefront of the biotechnology industry, using innovative science to developbreakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, CAheadquarters:

Assistant General Counsel/Senior Corporate Counsel Description: The Senior Corporate Counsel or Assistant General Counsel (Specialist) (title dependent on level of

experience) will work as part of the Healthcare Law Group within Genentech's Legal department. The position will have the opportunity to provide legal advice and support across the lifecycle of Genentech's products, including commercial, medical affairs, development and manufacturing functions. Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs and development teams that have human medicines and companion diagnostics in all

phases of development, and manufacturing. Qualifications:

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The ideal candidate will have a JD with Bar admission from a top tier law school, and will have between 7 and 25 years in practice, including at least 5+ years of recent relevant legal experience at a law firm with a nationally-recognized FDA / Life Sciences practice or in a pharmaceutical or biotechnology company’s law department, with a focus on counseling pharmaceutical and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines and companion diagnostics. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is essential, along with excellent oral and written communications skills. Demonstrated leadership on cross-functional teams and the ability to be accurate and influential in presenting complex information to all levels of management are also expected of the candidate to be successful in the role. Passionate about our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life.Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. Apply Below!

Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. Genentech is an Equal Opportunity Employer: Minorities/Women/Disability/Veteran. ******************************************************************

https://www.linkedin.com/jobs2/view/13726093 Business Development Manager BioSurplus - San Francisco Bay Area

Posted 1 day ago About this job Job description

SCOPE AND RESPONSIBILITIES 1. Target and build relationships with companies to establish partnerships for ongoing equipment

supply 2. Support the overall process of management and corporate decision making to ensure the

organization meets revenue goals

3. Attend industry functions such as seminars and networking events, and provide feedback and follow up to prospective suppliers and customers

4. Support overall corporate goals and promote all services provided by company 5. Develop contact database and work within a multitude of programs to identify leads and

opportunities to build ongoing supply pipeline 6. Negotiate contracts for purchase, consignment and/or auctioning of equipment. 7. Assemble detailed contract exhibits that include accurate equipment listings from suppliers BioSurplus is currently seeking to hire a Business Development Manager for its South San Francisco

location. The Business Development Manager is responsible for identifying ongoing equipment supply acquisitions in Northtern California. The goal is to develop relationships with key decision makers within life science companies to become their vendor of choice for surplus equipment redeployment. The position will also build relationships/partnerships with key stakeholders in the life science community such

as vendors, associations, etc. to leverage our market impact/growth. Desired Skills and Experience EXPERIENCE / SKILL REQUIRED 1. Previous sales, marketing and/or business development experience in the life science industry.

2. Must have a science degree or bench experience or job related experience with R&D lab equipment 3. Proven track record building new business cold calling and finding decision makers 4. Science degree and/or lab experience 5. Ability to work independently as well as collaboratively 6. Proficient in Excel, Word, Power Point and CRM

7. Experience networking vertically within life science companies -- including C-level 8. Good project and time management skills; ability to multi-task is a must 9. Solid organizational skills 10. Excellent communication skills – written and verbal

12/14/2014 4

11. Ability to communicate effectively both internally and externally About this company Follow company BioSurplus is a leading provider of equipment management solutions and pre-owned scientific instruments to the life sciences industry. BioSurplus offers an array of equipment management and valuation services, utilizing its proprietary methodology to assist companies during corporate M&A, upsizing, downsizing, and liquidation transition periods. Founded in 2003, BioSurplus offers solutions for every stage of the laboratory equipment life cycle — from buying to selling — and managing every process in between. We offer services nationally, internationally and sell equipment worldwide. BioSurplus is headquartered in San Diego, CA, with additional locations in the San Francisco Bay Area and Boston, MA. Similar jobs ****************************************************************** Apply on company website Senior Manager, Supply Chain Strategy and Risk

Gilead Sciences - Foster City -California -US Posted Dec. 6 54 Applicants

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Job description Specific Responsibilities: This position is responsible for developing the global Supply Chain strategy including analyzing and driving

short and long range plans to ensure commercial drug product supply. Essential Duties and Job Functions: The individual in this role will drive the following:

Strategy • Identify, evaluate and optimize the Supply Chain by identifying opportunity, improving Gilead processes to operate efficiently and in support of global growth and speed.

• Develop a program to collect, update and analyze capacity data across the Gilead network. • Identify, evaluate, recommend and own a risk tool to best support modeling of product and CMO distribution.

Risk • Characterize supply chain risks across the global commercial supply chain. • Identify and evaluate supply chain risk mitigation plans within Gilead and with key partners.

Supply Chain Strategic Planning •Develop and maintain the 3-5 year Commercial Manufacturing and Supply plan. •Network capacity modeling for CMO/CPO. Develop plans and initiatives to balance availability and improve supply chain risk overall utilization

•Analyze and recommend production and packaging supply chains to support regulatory filings and proper balancing of production volumes, insuring current and future requirements can be met in accordance with the strategic plan. •Perform scenario analysis to assist in driving short and long-range production plans and analysis and model various scenarios.

•Provide visibility to long term critical supply situations and for escalation to management. •Lead the formulation and execution of strategic initiatives and the processes, tools, and systems needed to support them. Develop and manage a repeatable process and program. •Identifying process improvement opportunities, key issues, development of conclusions, and

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implementation plans supported with qualitative and quantitative analysis. •Lead suppliers in developing advanced supply chain processes to improve the management of inventory levels, risk mitigation, and supplier efficiency. •Provide development opportunities and continuous process improvement. •Analyze product inventory plans including inventory levels, scrap, inventory purchases and consumption. Develop Safety Stock Strategy for drug substance and drug product (strategic and operational). •Anticipate roadblocks, both intellectual and political, and proactively address issues before they impact business results. •Assess business continuity preparedness within Supply Chain and participate on corporate initiative as developed. Leadership, Teamwork and Collaboration •Work cross functionally with multiple functional areas to understand short and long term requirements affecting commercial supply; e.g. Finance, Commercial Ops, Development, Clinical, Chemical Manufacturing, sites, CMOs, Pharm Manufacturing & Technical. •Lead working teams across functional areas globally in support of developing, analyzing and executing

against the strategy. •Work with cross functional organizations, notably the development and technical teams to analyze and influence decisions on sourcing and LT capacity requirements and utilization. Model equipment trains/technology capacities and recommend balancing of overall supply and capital investments.

•Use expertise to influence strategy, planning and supply chain processes. •Represent Supply Chain on Supplier Relationship teams. •Understand how each CMOs material and capacity planning fit into our business process and long term direction.

•Develop reports with Key Suppliers to improve visibility of material risk. •Manage supply risk mitigation activities with key suppliers. •Provide leadership, guidance, mentorship, and training to planners, buyers, and suppliers. •Responsible for initiating and leading internal and external cross-functional project teams.

•Participate in cross-functional team for external sourcing strategy. •Manage recovery plans and network allocations in shortage situations Communication •Establish process for period review and dissemination of information to key leaders and stakeholders

•Identify opportunities and make recommendations to balance and relieve capacity imbalances, shortfalls and bottlenecks. •Support site selection process to ensure consistency with commercial strategy. •Analyze and influence strategy for in-house versus sourced production and recommend volume splits.

Monitor, track and report against strategy and key metrics. •Independently develop and refine project scope, structure, and approach. Identify key issues, guide and execute analysis, develop conclusions, and present findings, suggestions and routine updates to members of the leadership team.

•Maintain excellent communication lines with all sources of demand and supply. •Develop business cases to support project prioritization.

Knowledge, Experience and Skills: •Demonstrated supply chain strategy and risk management track record working with senior management

teams. •An independent self-starter with the ability to resolve supply chain challenges and implement improvements •Ability to develop, analyze, and leverage key metrics to improve overall business performance •Proven ability to lead problem solving, build strong relationships and to organize effectively

•Business acumen and analytical problem solving skills with an ability to anticipate operational issues and recommend solutions •Strong familiarity with supply chain and risk systems •Demonstrates effective communication skills and the ability to deal across several multi-national sites

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and organizations to include third party partners •Advanced Degree in Supply Chain Management, Operations, Business, or Accounting •7 + years of experience in Corporate Planning or Supply Chain Management within manufacturing. Experience to include supply and demand analysis, purchasing, logistics, capacity planning, inventory management (levels, purchases, consumption), risk mitigation, and supplier efficiency. •3 + years project management in a lead role (define, approve, develop milestones and metrics; oversee budget; work actively with senior management). •APICS certification preferred _______________________________________________________________ Associate Manager, Business Systems Analyst - Clinical Systems Gilead Sciences - Foster City -California -US Posted 21 hours ago Apply on company website Other Details About this job Job description

Specific Responsibilities: Gilead was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational

drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012,

Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. Essential Duties and Job Functions:

Work as part of a team to manage, maintain, and support various clinical systems for clinical operations. Support end users in using the system, enter/track support tickets, and resolve issues in timely fashion with quality. Provide ad-hoc queries/analysis, report creation, and automation of reporting processes to support business needs. Follow procedures and SOPs and execute technical and operational tasks. Manage

validated computer system change control process and documentation. Understand and gather business requirements, write and execute test scripts. Be able to analyze and solve problems and learn new technologies. Collaborates with cross functional teams and drive projects to timely completion.

Knowledge, Experience and Skills: BA or BS in a scientific or technology discipline or equivalent with 7+ years of experience (MS with 5+ years) in managing, testing, and supporting enterprise level systems is required. Solid understanding of

GxP computer system validation, documentation and change control process Good verbal, written and interpersonal communication, customer service and organizational skills are required. Must be able to work closely with end users, understand business processes and work effectively with cross functional teams. Must have experience in system testing and documentation. Experience in supporting Siebel

eClinical and/or other validated systems in GxP pharmaceutical environment and reporting visualization/dashboards is a plus. Project Management skills in system implementation is a plus. Individuals with sufficient relevant experience without formal degree will also be considered ************************************************************************

Executive Director, Business Analytics & Market Insights https://www.linkedin.com/jobs2/view/22058834?trk=jobs_jig_jobs Pharmacyclics - Sunnyvale, CA Posted 4 days ago About this job

Job description General Position Summary/Purpose:

12/14/2014 7

The Executive Director, Business Analytics and Market Insights partners closely with the Commercial and Finance organizations. Business Analytics and Insights (BAI) provides strategic, cumulative and in-depth market data, insights and recommendations to key stakeholders and functions; helping such business partners/stakeholders to make optimal informed strategic and operational decisions regarding their business strategies, plans, tactics and goals. Responsibilities will include forecast development and tracking of in-line (both US and ex-US), lifecycle and pipeline/business development opportunities, as needed. Forecast work will include development and maintenance of unit and revenue assumptions with other focus areas including analysis of secondary data sources to address strategic business questions, and assist with management reporting. Collaborate with external customers / Alliance Partner in the collaboration efforts with to align on key assumption and insight generation. Key Accountabilities/Core Job Responsibilities:

Lead development of forecast assumptions that support unit and revenue long range forecasts via either patient and/or share based models. Aid the finance team in the design of forecast models when needed with input.

Forecasting and strategic support work will include in-line agents, new indications, pipeline agents and BD support (as needed)

Development of epidemiological models and assumptions to support forecasting efforts. Development of incentive compensation plan for field sales organization, territory alignment,

territory goal development and execution. Ability to partner with internal cross functional teams to develop incentive compensation plan.

Design and conduct quantitative analytics and modeling on secondary data (such as third party claims or IMS DDD/Xponent) to address business questions such as ROI analysis and provide insight into current market performance. Also assists Finance with short term forecasting. Develop and issue performance update reports to management on key topics.

As needed, participate in the design and execution of market research projects focused on critical forecast inputs such as share, patient treatment patterns, length of therapy, etc.

Translate primary and secondary insights including market research, secondary data and competitive intelligence into key long-range patient based forecast model assumptions.

Acts as an internal consultant to partners/stakeholders across sales/marketing, managed care marketing, clinical, research, regulatory, finance, manufacturing, and others, building strategic thought partner relationships within the Pharmacyclics and partner organizations in order to support strategic decision making across functional areas.

Provide a holistic and objective analytical viewpoint of the market and commercial opportunities

through ongoing situation analysis and deep understand of key issues including a clear understanding of market dynamics, customer needs, and competitive activities.

Develop presentations with clear storylines, communicating key insights and recommendations while integrating data sources and existing team knowledge.

Maintain cutting edge skills in the latest forecasting, data modeling methodologies, quantitative market research techniques, and applications that support forecast development and business analytics.

Prepare written summary reports and/or oral presentations of project outcomes in an efficient,

logical and concise form with minimal guidance Desired Skills and Experience Qualifications:

13-15 years of experience working in the pharmaceutical or biotech industry with 8 plus years

experience in Market Research, Forecasting, Marketing Sciences, Data Management. Successful track record in hiring, managing and developing direct reports Experience in supporting launch products and/or new launch indications with forecasting and

strategic decision support

Experience in both US and ex-US modeling Strong strategic and analytical skills, including past experience with Excel based market and

financial modeling are required. Experience with scientific literature searches and epidemiology data sources, including knowledge

of their strengths and limitations is required.

Experience with secondary data: syndicated sales, promotional & marketing data, longitudinal patient-level data, payer data. Additional knowledge of primary market research or medical research data is a plus

Experience using patient level data (medical/retail claims) to analyze treatment/usage patterns

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Experience conducting or analyzing market research and data (particularly predictive share modeling, e.g., conjoint-based choice models and other multi-vitiate techniques) is preferred.

Hands on experience using a wide range of pharmaceutical secondary audits (e.g. IMS DDD and Xponent) including the design, analysis and integration with primary research, sales, marketing and other internal/external sources of data and intelligence.

Previous experience in oncology is required and experience specifically in hematology is a plus Extensive proficiency with Microsoft Office (Word, Excel, PowerPoint and Outlook) and forecasting

software (e.g., Crystal ball, Forecast Pro, customized platforms) Excellent communication, analytical and strategic thinking skills with Executives Ability to develop and maintain strong team relationships while driving for positive results Ability to work with focus and great attention to detail Ability to successfully work with a wide range of personalities Strong vision to building out functional area within a fast moving, entrepreneurial environment.

Education Requirements (degree, certifications, etc.): Bachelor’s degree in Life Sciences; Graduate Degree and/or MBA preferred

About this company

Follow company At Pharmacyclics our people are our greatest asset. The collective ingenuity, commitment and drive of our employees has created an exciting future where we can discover, develop and commercialize, novel therapies that make a difference for the betterment of patients. The drive for innovation and progress

creates challenging opportunities for our employees as they work toward developing cures for disease areas with significant unmet medical needs. We have a culture that is driven by innovation, collaboration, teamwork and results. Our high-energy

team has a common purpose that is committed to improving the lives of patients around the world. We believe that attracting, developing and retaining a base of employees that reflects the diversity of our customers is essential to our success.

*********************************************************************** Apply at company website Strategy Director, Corporate Development Impax Laboratories - Hayward, CA Posted 5 days ago

Apply on company website Other Details 24 Applicants

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Job description Position Summary: The Strategy Director will work closely with Senior Management as the Integration Lead to support an

aggressive external growth (M&A) agenda. The Strategy Director will also be the day-to-day lead on cross functional Strategic Planning Initiatives and Corporate Strategy projects to be delivered to the Senior Executives and Board. Essential Duties/Responsibilities:

Lead cross-functional teams on Transition Planning, Integration Planning, and Integrations projects for acquired products, technologies, business units, and companies, including management of external consultants where appropriate.

Lead cross-functional Corporate Strategy project teams on key growth initiatives (e.g., therapeutic area expansion, international expansion, manufacturing network optimization, etc.)

Lead the period Strategic Planning efforts to be delivered to the Impax board. Desired Skills and Experience Qualifications:

Deep experience leading and supporting post-merger integrations, preferably in health care.

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Prior experience at a top tier management consulting firm. Exceptional written and oral communication skills. Demonstrated ability to evaluate and interpret complex problems, excellent analytical skills. An ability to generate a broad and productive internal network. MBA or advanced degree, science educations backgrounds in areas relevant to the Pharmaceutical

industry a plus. Prior management experience is desired.

About this company Impax Laboratories, Inc. is a technology-based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. ****************************************************************** https://www.linkedin.com/jobs2/view/27316237?trk=job_view_browse_map&trk=job_view_browse_map Director / Sr. Director, Business Analytics Adamas Pharmaceuticals, Inc. - San Francisco Bay Area Posted 5 days ago

Other Details About this job Job description The Director/Senior Director Business Analytics supports the Adamas commercial organization decision-

making by leading the business analytics processes, delivering strategic insights for launch planning activities, and works closely with the New Product Discovery team in the assessment and selection of new products and expansion indications.

The individual will participate actively in commercial planning efforts by providing objective, in-depth analyses on current and future markets, establish product forecast models, lead revenue planning activities in alignment with Adamas’ business planning cycle, establish key metrics and track performance for product launches, develop customers insights, and competitor assessments. Additionally, the individual

will analyze data to identify critical business issues and opportunities for growth, collaborate with Adamas teams, and work to entrench an external market point-of view into the strategic direction of the company. The Director/Senior Director Business analytics will be a member of the commercial leadership team and will report directly to the head of the commercial organization.

Specific Responsibilities:

Proactively and continuously assess the relevant marketplaces and dynamics, customers and

competitors to enable strategic decision making regarding products and business operations. Creates, manages, validates, and refines revenue forecasts. Develops and implements market research plans in all customer segments, including providers,

payers, patients, caregivers, etc., in collaboration with cross-functional teams to support pre-

launch and launch activities for lead molecule and future indications. Business partner within assigned cross-functional teams: developing strategic insights and

providing in-depth product and marketplace knowledge to inform strategic decision. Supports the New Product Discovery team in assessments of new products and expansion

indications. Provides analytical support to Corporate Development during due diligence for in-license

opportunities and partnering activities. Continuously monitors public and private competitors, keeping abreast of clinical, regulatory,

commercial, and financial developments and their impact on Adamas. Actively contributes to cross-functional or other project teams, helping the overall business evolve,

improve & excel. Will be a key member of the commercial launch leadership team and will lead the business

analytics sub team.

Delivers results in a timely manner with high levels of accuracy, and continually striving to exceed expectations and evolve processes.

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Desired Skills and Experience 10+ years of biotech/pharma or related experience in commercial related roles with at least 5+ years in a business analytics leadership role. Bachelor’s degree required. MBA or other related graduate-level degree preferred. Previous experience with leading teams, managing and developing high performing individuals. Extensive experience with the following:

Proven track record for leadership, collaboration, teamwork and consistently exceeding qualitative, and quantitative targets and goals.

Product launches with specialty markets. Development of excel based revenue forecast models. Leading and managing primary market research with all segments of the healthcare system. Extensive experience in use and analysis of industry prescription data sources (IMS, Symphony

Health Solutions, etc.). Conducting quantitative research, including conjoint analysis and ATU’s. Building systems for tracking and evaluating competitive activities.

Evaluating and assessing development options as it relates to commercial potential CNS or neurology related areas is a plus. Fit with Adamas culture and values

About this company

Follow company Adamas is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system (CNS). We achieve this by enhancing the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. For

more information about the company and the team, visit our website at www.adamaspharma.com *******************************************************************

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12/5/2014 Director, Commercial Compliance Depomed, Inc. Newark, CA

City NewarkState California [CA]Title Director, Commercial ComplianceDepartment LegalDescription This position will have a leadership role in Legal and Compliance at Depomed and will report to the Compliance Officer. This position is responsible for... 12/5/2014 Product Owner Roche Molecular Diagnostics Pleasanton, CA

We are looking for a person experienced in the development of medical device software associated with the operation of IVD diagnostic tests running on automated systems. This position fosters the close collaboration between the business head quarter...

12/5/2014 Sr. Environmental Health & Safety Professional II Roche Molecular Diagnostics

Pleasanton, CA

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Responsibilities: As a member of the Safety Health and Environmental (SHE) team this professional will be responsible for the listed responsibilities. As the site and business grows the responsibilities of the SHE professional with change to meet...

12/5/2014 Sr. Corporate Counsel Roche Molecular Diagnostics Pleasanton, CA

Responsibilities: Advises and counsels Roche's life cycle teams in the areas of companion diagnostics, point of care, life sciences, and women's health. Interfaces with other departments in the Roche Group, including global teams, e.g. as part of...

12/5/2014 Scientist (R3) - Biology (Non-PhD) Pfizer Inc. South San Francisco, CA

Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as... 12/5/2014

Scientist - Biology (R3) - Cancer Therapeutics (Non-PhD) Pfizer Inc. South San Francisco, CA

Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as...

12/5/2014 Senior Scientist (R4), Protein Engineering Pfizer Inc. South San Francisco, CA

Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as...

12/5/2014

Principal Scientist (R5), Experimental Medicine

Pfizer Inc. South San Francisco, CA Org marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our

business and our world. That's why, as... 12/5/2014 Scientist (R3) - Biology (Non-PhD) Pfizer Inc.

South San Francisco, CA Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact

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health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as... 12/5/2014 Senior Scientist (R4), Experimental Medicine Pfizer Inc. South San Francisco, CA

Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as...

12/5/2014 Senior Scientist (R4) - Cancer Immunotherapy Pfizer Inc. San Francisco, CA

Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our

business and our world. That's why, as...

Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer,...

12/5/2014 Senior Diagnostic Consumables Engineer Cepheid Sunnyvale, CA

As a Senior Diagnostic Consumables Engineer you will be a part of a fast pace, multi-disciplines, and creative team that drive new product development and implement continuous improvements to new and existing processes. The ability to develop... 12/5/2014

Senior Regulatory Affairs Specialist Cepheid Sunnyvale, CA

The Senior Regulatory Affairs Specialist performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions,... 12/5/2014

Auditor GMP Regeneron Pharmaceuticals, Inc. San Francisco, CA

**THIS POSITION REQUIRES RELOCATION TO RENSSLEAR, NY** Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines...

12/5/2014 Clinical Trial Associate MacroGenics, Inc.

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South San Francisco, CA Clinical Trial Associate MacroGenics, Inc., a growing biotechnology company, has an opening for a Clinical Trial Associate in its South San Francisco facility. Responsibilities include: assisting with development and formatting of documents (e.g.... 12/5/2014 Auditor GMP Regeneron Pharmaceuticals, Inc. San Diego, CA

**THIS POSITION REQUIRES RELOCATION TO RENSSLEAR, NY** Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines...

12/5/2014

Supply Chain Specialist Ultragenyx Pharmaceutical Inc. Novato, CA

Why Join Us Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...

12/5/2014 Principal System Engineer I Roche Molecular Diagnostics

Pleasanton, CA This position plays a key role in increasing the Development Department’s capabilities in development and validation of instrument systems for running molecular diagnostic tests for the Point of Care market.

Experience in automating... 12/5/2014 Sr. Mgr, Global Digital Marketing

Roche Molecular Diagnostics Pleasanton, CA

ResponsibilitiesEstablishes Global Digital Marketing strategies for 3 Lifecycle teams (LCTs) including new

Point-of-Care LCT, aligned with the Business Area.Responsible for planning and execution of critical activities in support of LCT strategies,...

12/5/2014

Sr. Financial Analyst Roche Molecular Diagnostics Pleasanton, CA

The Senior Financial Analyst, Corporate FP&A, acts as a business partner to RMD leadership with a focus on both strategic and tactical issues surrounding the business. The core role of the Senior Financial Analyst is, together with Business Area...

********************************************************************* 12/5/2014 Senior Clinical Director

12/14/2014 17

Proteus Digital Health Redwood City, CA

Finding a good job is very good. Finding a good job in a dynamic, growing company is great. Finding a great job in a world-changing organization is a once-in-a-lifetime opportunity. Welcome to Proteus Digital Health, where we’re pioneering a new...

View Job

12/5/2014 Senior Scientist, CMC Relypsa Inc. Redwood City, CA

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery

and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...

View Job

12/5/2014 Senior Director, HEOR Relypsa Inc. Redwood City, CA

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery

and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...

View Job

12/5/2014 Scientist/Staff Scientist I, Analytical Development Relypsa Inc.

Redwood City, CA

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...

View Job 12/5/2014 Research Associate III/Senior Research Associate, Analytical Development

Relypsa Inc. Redwood City, CA

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Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...

View Job 12/5/2014 Principal Scientist, Quality Control Relypsa Inc. Redwood City, CA

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and

renal diseases. Relypsa's lead product...

View Job

12/5/2014 Medical Science Director(s) Relypsa Inc. Redwood City, CA

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and

renal diseases. Relypsa's lead product...

View Job

12/5/2014 Medical Director, Clinical Development Relypsa Inc. Redwood City, CA

Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of

novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer,...

12/5/2014 Executive Director, Drug Safety and Pharmacovigilance Relypsa Inc. Redwood City, CA Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product... 12/5/2014 Director, Quality Control Relypsa Inc. Redwood City, CA

12/14/2014 19

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product... 12/5/2014 Contract Specialist Real Staffing San Diego, CA

A major health system in San Diego is looking to add a contract specialist/buyer to their procurement team. This position is for a 6 month contract and is looking to start ASAP. Title - Buyer IVDuration - 6 monthsRequirments:*Minimum of 3-4 years of...

12/5/2014

Medical Writer III Real Staffing Irvine, CA

Job RequirementsMust have MS, or PHD in related field.0-3+ years of experience.Strong communication skills, solid MS Office, Adobe Professional, XML computer skills, and proven negotiation skills are a must.Attention to detail and ability to work in...

12/5/2014 Chief Clinical Transformation Officer Real Staffing San Francisco, CA

The Director of Clinical Transformation will lead the planning, development and execution of clinical standardization efforts for the 1,100+ physician members of the health Clinic. Working closely with the Health Clinic Chief Medical Officer, the...

12/5/2014 Regulatory Affairs Director Real Staffing San Diego, CA

RESPONSIBILITIESPrepare and oversee as necessary the preparation of all FDA submissions; 510K's, IDE's, PMA's, etc.Prepare and oversee as necessary the preparation of all European registrations for new or modified products; CE marking,...

12/5/2014 Senior/Principal Engineer Real Staffing Emeryville, CA

I am currently recruiting for a Principal R&D Engineer to join one of my well funded Medical Device start-ups in the East Bay area. This role will be responsible for the research and development of the company's

initial product.This is a great...

12/5/2014

IT Project Manager Real Staffing Martinez, CA

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A healthcare provider is looking to hire an IT project manager to join their team. Responsibilities include: *Working with clinical and business users to identify and document requirements*Work with the Project Management Office to incorporate...

12/5/2014 Manufacturing Engineer Real Staffing Goleta, CA

Duties and Responsibilities:- Prepares mechanical drawings of parts and assemblies- Performs detail design including tolerance analysis, and fit & fiction validation- Manages Solidworks PDM servers for both production and R&D teams- Manages...

12/5/2014 Auditor GMP Regeneron Pharmaceuticals, Inc. Los Angeles, CA

**THIS POSITION REQUIRES RELOCATION TO RENSSLEAR, NY** Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines...

12/5/2014 Auditor GMP Regeneron Pharmaceuticals, Inc. Orange County, CA

**THIS POSITION REQUIRES RELOCATION TO RENSSLEAR, NY** Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines...

12/5/2014 Research Scientist 2, Cancer Biology Tocagen Inc.

San Diego, CA Function/Scope: The Research Scientist 2 will be responsible for the fully independent conception, design, development, execution, and interpretation of scientific research projects relating to cancer gene therapy

research & development. The... 12/5/2014 Chief Clinical Transformation Officer

Real Staffing San Francisco, CA The Director of Clinical Transformation will lead the planning, development and execution of clinical standardization efforts for the 1,100+ physician members of the health Clinic. Working closely with the

Health Clinic Chief Medical Officer, the... 12/5/2014 Regulatory Affairs Director

Real Staffing San Diego, CA

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RESPONSIBILITIESPrepare and oversee as necessary the preparation of all FDA submissions; 510K's, IDE's, PMA's, etc.Prepare and oversee as necessary the preparation of all European registrations for new or modified products; CE marking,...

12/5/2014 Senior Programmer (SAS) Real Staffing San Francisco, CA Senior Programmer - South San Francisco, CADuration - 12 MonthsRate - $90+ Hourly A large Biotechnology organization is actively seeking a Senior Programmer to assist on upcoming studies.Key Features: Provides clinical programming support for... 12/5/2014 QA - Software Real Staffing El Dorado Hills, CA

o Risk Management o 62304 as related to Medical Device, MDDS, Standard SDLC o CAPA and Complaints o Quality System Management o Supplier Quality, auditing Medical Device experience required.

12/5/2014 Medical Reviewer Real Staffing Thousand Oaks, CA

Medical Reviewer - Thousand Oaks, CADuration - 18 MonthsRate -$50= Hourly A large Biotechnology company is actively seeking an experienced Medical Reviewer to assist with numerous Case Safety Reports. Key Features:- To access and work on individual...

12/5/2014 Project Manager Of Operations Real Staffing Los Angeles, CA

Responsible for supporting the Vice President, IPA Operations in ensuring that all IPA projects are successfully completed. ESSENTIAL FUNCTIONS:Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners' (HCP)...

12/5/2014 SAS Programmer Real Staffing

Los Angeles, CA The Contract Statistical Programmer will develop, test, validate, document, maintain and execute programs in SAS and may serve as lead programmer as appropriate. Will take primary role in review and

validation of SAS programs created by more... 12/5/2014 HS IT Project Manager Real Staffing Martinez, CA

A leading healthcare provider in Northern California is looking for an IT Project Manager. This person will be responsible to oversee all functions of the project from design, development, analysis, and testing. The project manager will consult with...

12/5/2014 Electrical Engineer Real Staffing

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San Francisco, CA

cal Engineer Primary Function of Position:This job exists to conceptualize, design, develop, and support vision products within the ISI New Product Development group, with a focus on high-quality image acquisition and high-speed data transmission in...

12/5/2014

Clinical Trial Manager Real Staffing San Francisco, CA

Team Duties/Responsibilities:Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities:Site identification, recruitment, and selection. Regulatory document...

o Risk Management o 62304 as related to Medical Device, MDDS, Standard SDLC o CAPA and Complaints o Quality System Management o Supplier Quality, auditing Medical Device experience required.

12/5/2014 HS IT Project Manager Real Staffing Martinez, CA

A leading healthcare provider in Northern California is looking for an IT Project Manager. This person will be responsible to oversee all functions of the project from design, development, analysis, and testing. The project manager will consult with...

12/5/2014 Clinical Trial Manager Real Staffing San Francisco, CA

Team Duties/Responsibilities:Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities:Site identification, recruitment, and selection. Regulatory document...

12/5/2014 Senior Software Engineer Real Staffing Mountain View, CA

Specific Duties and Responsibilities: * Technical ownership of the system services, operating system and board support layers of the ultrasound system software. Lead design and development of core system features such as software installation,...

12/5/2014 Electrical Engineer Real Staffing San Francisco, CA

Our Client is a well-established medical device company looking for a high level Electrical Engineer. This Electronics Engineer opportunity is located in San Jose. Responsibilities:Evaluates electrical systems, products, components, and applications...

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View Job 12/5/2014 Medical Technical Writer Real Staffing San Francisco, CA

Our Client is looking for a Technical Writer to join their Integration team to write clear documentation for their partners. What you will do:Make their enterprise partner integrations a seamless experienceWork alongside the Integration Engineers...

View Job

12/5/2014 Senior- Principal SAS Programmer Real Staffing San Diego, CA

-Develop and maintain the programs including, testing, and organizing the SAS datasets, SAS programs, and related documentation.-Design, develop, and validate SAS programs for the generation of data tables,

listing, and figures for clinical study...

12/5/2014 Senior Associate Of Medical Writing

Real Staffing Los Angeles, CA Doctorate Degree (PhD, MD, PharmD) with 3+ years experience in medical communications is preferred,

but candidates with other strong relevant experience will be considered. Experience/training in oncology is preferred. Candidate must be able to lead... 12/5/2014 Business Manager

Real Staffing San Francisco, CA

Key Features:Evaluates functional or project sourcing specific needs and how they can impact the current

sourcing strategy(ies)Defines project- or function- specific sourcing strategies with input from project team members or functional..

12/5/2014

R&D Design Engineer Real Staffing Redwood City, CA Real Staffing is looking for a R&D Design Engineer to join a mid-sized medical device company in Redwood City, CA.Company: Established mid-sized company that has a unique and one-of-a-kind medical device product located in Redwood City, CA. Role:... 12/6/2014 Accounting Assistant Alexza Pharmaceuticals Mountain View, CA

12/14/2014 24

Alexza Pharmaceuticals, a specialty pharmaceutical company located in Mountain View, California, leads the way in providing non-invasive, novel therapies for the acute treatment of central nervous system conditions. Our product candidates are based... 12/6/2014 Biologist - Contractor Discovery Solutions San Diego, CA COMPANY: Discovery Solutions is seeking job seekers for a contract position with one of our customers, Lilly, a leading pharmaceutical company headquartered in Indianapolis, IN. LOCATION: San Diego, CA DESCRIPTION: Conduct experiments to... 12/6/2014 Senior Research Associate I, Cell Biology AnaptysBio, Inc.

San Diego, CA In this Senior Research Associate I position you will assist in generating and characterizing therapeutic antibodies using hybridoma and in vitro methodologies. You will be responsible for using the AnaptysBio

mammalian cell surface display platform... 12/6/2014 Research Associate II, Cell Biology

AnaptysBio, Inc. San Diego, CA

As a Research Associate II you will assist in the generation and characterization of therapeutic antibodies using in vitro methodologies, including flow cytometry, ELISA, and other cell-based assays. You will be responsible for using the AnaptysBio... 12/6/2014

Administrative Assistant for Marketing, Sales and Manufacturing NovaBay Pharmaceuticals, Inc. Emeryville, CA

Summary of Role The Administrative Assistant for will provide administrative support of Marketing, Sales and Manufacturing Groups. In this important role you will be part of our winning sales team, leading commercialization efforts for this key new...

12/6/2014 Inside Medical Device Sales / Customer Service Representative NovaBay Pharmaceuticals, Inc. Emeryville, CA

Summary of Role: The Inside Medical Device Sales / Customer Service Representative will become a significant contributor to the NovaBay i-Lid Cleanser commercial team as our dedicated sales force launches the product. In this important role you will...

12/6/2014 Assistant Product Manager, Marketing NovaBay Pharmaceuticals, Inc. Emeryville, CA

Summary of Role: The Assistant Product Manager, Marketing, will be a hybrid role of brand marketing, brand management, and strategic communications. Primary responsibilities will be: strategic communications and professional marketing launch plans...

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12/6/2014 Research Associate (RA) (Biology) Wellspring Bioscience LLC La Jolla , CA Wellspring Biosciences is discovering and developing small molecule drugs that target signal transduction networks for the treatment of cancer and other diseases. Through partnerships with academic and industry experts, we are translating chemical... 12/5/2014 Synthetic Organic Chemist all levels Acme Bioscience, Inc. Palo Alto, CA Acme Bioscience is a contract research organization, located at Palo Alto, California. We have immediate

opening for synthetic organic chemist at research scientist. Qualified candidates should have a PhD degree in field of synthetic organic... View Job

12/5/2014 GLP Auditor Regeneron Pharmaceuticals, Inc. Los Angeles, CA

12/5/2014 Mechanical Design Engineer IV

The Bionetics Corporation Moffett Field, CA

JOB DESCRIPTION: The Mechanical Design Engineer IV is responsible for mechanical design, review, and engineering in support of NASA’s Space Biology projects and the Bioculture System payload. This job may require job related travel and the...

12/5/2014

Principal Medical Writer Real Staffing San Diego, CA

Job RequirementsBA/BS, MS, or PHD in Scientific or Medical Field.5 years of regulatory medical writing experience in the pharmaceutical or biotech industry.Experience writing clinical protocols, clinical study reports (ICH E3), and Investigator...

12/5/2014

Contract Specialist Real Staffing San Francisco, CA

A major health system in San Diego is looking to add a contract specialist/buyer to their procurement team. This position is for a 6 month contract and is looking to start ASAP. Title - Buyer IVDuration - 6 months Requirments: *Minimum of 3-4 years...

12/5/2014 Global Studies Manager Real Staffing San Francisco, CA

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Key Features -Provides direction and leadership to one or more clinical operations teams. Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management....

12/5/2014 QA Specialist III Real Staffing Foster City, CA

Primary Job Responsibilities:Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met. Maintains routine...

12/5/2014 Validation Engineer Real Staffing

Thousand Oaks, CA

* Independently develop, implement and perform IQ/OQ/PQ for facilities, equipment and processes in an ISO 13485 Certified, GMP Compliant production environment.* Prepare Validation Reports.* Establish and maintain the Validation Master Plan and...

12/5/2014 Manager Medical Affairs- Medical Device Real Staffing Redwood City, CA

An exciting Medical Device company located in Redwood City, CA, is urgently seeking a Medical Affairs Manager. This is a John Simpson company with a track record of success and an unbeatable company culture that enables it's team members to utilize... 12/5/2014

Medical Technical Writer Real Staffing San Francisco, CA

Medical Writing, Senior Technical EditorClinical Science | San Francisco, CA, United StatesWorking closely with medical writers, this individual may also provide copyediting support. Documents include, but are not limited to, clinical study reports...

12/5/2014 Global Studies Manager Real Staffing San Francisco, CA Key Features -Provides direction and leadership to one or more clinical operations teams. Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management....

12/5/2014 Firmware Engineer Real Staffing San Jose, CA

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Embedded Systems Software EngineerOur Client is looking for an embedded systems software engineer to join a rapidly growing medical device company. You will be working with a small team of software engineers and given the opportunity to improve our...

********************************************************************* Meredith McClanahanRecruitment Services Specialist at BioPhase Solutions

http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=3670

Sales Account Manager - Life Sciences BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are recruiting for an area Sales Account Manager to work with our life science client. This position is direct hire; and ‘work from home’ capability with a Bay Area (East Bay) and Pacific Northwest territory.

Sales Account Manager - Life Sciences Position Duties and Responsibilities:

Present products and services through sales calls, lead follow up, on-site seminars, trade shows, and user meetings

Technically competent and detailed oriented on all company product and service portfolio Write quotations for the opportunities once requested by the customer and provide this quotation

to customer service Maintain an accurate sales forecast which must be updated weekly. The Account Manager will work with service specialists to identify and close non-product

opportunities. The Account Manager should communicate with these specialists at least weekly Meet with customers, in person, at least 4 days per week

Identify new groups within existing accounts in addition to meeting with current customers Coordinate field visits with field scientists, specialists, regional managers, and corporate personnel

at least once per month Contact leads within 48 hours and process leads in sales management software within 7 days

Attend and participate, via web, in corporate meetings at least twice a month Performs other duties as required and assigned Overnight travel < 25%

Requirements:

A minimum education of a B.S. /M.S. in Biochemistry, Pharmacology or Molecular Biology Knowledge of the drug discovery and development process Two to five years of successful sales experience Self-starter who is a result and success oriented individual with the proven ability to develop and

follow through on sales tasks and plans Excellent interpersonal and relationship management skills Excellent written and verbal communication skills

************************************************************************** REGULATORY, QUALITY & CLINICAL AFFAIRS Director of Clinical Affairs

Bachelor’s degree in life science or relevant discipline. 510K medical device experience 10+ years clinical trial experience in medical device, outpatient procedures preferred Demonstrated knowledge of clinical trial design and methodology and Federal/ICH regulations that

apply to clinical investigations MANUFACTURING, OPERATIONS & R&D ENGINEERING Metrology Development Engineering Manager

Bachelor’s degree in Engineering. 5+ years experience in Metrology, Optics, Physics, Engineering or equivalent. Formal training and experience with mechanical or electrical calibration a plus.

12/14/2014 28

Experience with image processing and optical systems is preferred. Proven success leading technical teams is strongly preferred. Excellent written and oral communication skills are required. Experience in performing audits on metrology and quality processes desired – along with root

cause analysis of technical discrepancies/abnormalities. Ability to travel 10%, international travel required

Sr. Process Development Engineer (thermo-mechanical processing) Bachelor's degree in Mechanical, Industrial, Biomedical, Materials or Chemical Engineering, or

related discipline. 5+ years experience in process development engineering. Experienced in incorporating radiopaque markers Ability to communicate clearly and efficiently in a highly technical environment. Capacity to work independently, with minimal supervision. Experience working in a regulated environment is a strong plus Experience with gauge R&R, DOE set-up and analysis. Experience with Solidworks.

Supply Chain Manager Bachelor's Degree minimum Office automation software skills and highly experienced with the SAP systems 5-8 years experience in materials sourcing and supply chain management

Hands on experience in compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data and finally presenting the analysis, results and recommendations.

Experience detecting and solving problems by analyzing information, identifying the underlying principles, facts, reasons, and causal relationships, and developing and implementing a strategy to

solve the problem. Experience developing specific goals and plans to prioritize, organize, and accomplish work. Ability to perform well under tight deadlines. Strong vendor negotiation skills.

Sr. Manufacturing/Industrial Engineer BS degree in a relevant discipline (Industrial Engineering preferred) and 5-9 years of related

engineering experience or MS degree and 3-5 years of related engineering experience. Have a good understanding of Lean Manufacturing principles. Possess good English communication skills – both written and oral.

Mechanical Engineering Manager BS degree in a relevant discipline and 12 or more years of related engineering experience. Are experienced with Robot (Denso) programming and development. Have vision system (Cognex) programming and integration experience.

Have short pulse (Picosecond or Femtosecond) development processing experience. Have a solid background in SolidWorks. Have significant complex level engineering expertise. Experience in the medical device industry.

Possess good English communication skills – both written and oral. Proven leadership and management skills.

SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT Marketing Manager

Bachelor’s degree in life science or business discipline. MBA desired. Catheter Lab, Surgical and/or OR experience preferred Product marketing experience in a therapeutic medical device company (peripheral vascular

experience preferred)

Proven ability to effectively position and message product/procedure and develop strong sales support to drive product/procedure adoption.

Demonstrated success in building clinical education and marketing programs to drive product/procedure growth

Ability to travel 40% - 50%

Digital Marketing knowledge/experience is preferred Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com

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tel: 925-577-8135 ************* http://www.genengnews.com/jobs/searchdetails?id=505456 Marcom Specialist

Agilent Technologies, Inc. US - Santa Clara, CA Posted on: 12/5/2014 7:27:51 AM Description:

Competencies Required - Deep Marcom expertise, including demonstrated e-marketing expertise - Cross-discipline Marcom skills with expertise on new/emerging tactics, e.g. demonstrated competency in selecting from and implementing across a wide mix of techniques including advertising, PR, direct marketing - Experience with test & learn practices to optimize campaign performance - Experience in technology-oriented B2B environment - Knowledge of internal business strategies & channel requirements

- Project management experience - Knowledge of & relationship with strategic & local agencies / vendors - Demonstrated ability to collaborate effectively across different constituencies - Strong written and oral communication skills

- Ability to influence without authority - Domain knowledge not required, nice to have Accountability- (Specific metrics TBD by mgr) - Campaign performance against goals specified in program business case (.e.g. # leads, cost/ lead

$) - % of campaigns leveraging e-tactics - Campaign response rates (measures creativity / quality of a campaign)

Requirements: Competencies Required - Deep Marcom expertise, including demonstrated e-marketing expertise - Cross-discipline Marcom skills with expertise on new/emerging tactics, e.g. demonstrated competency in selecting from and implementing across a wide mix of techniques including

advertising, PR, direct marketing - Experience with test & learn practices to optimize campaign performance - Experience in technology-oriented B2B environment - Knowledge of internal business strategies & channel requirements

- Project management experience - Knowledge of & relationship with strategic & local agencies / vendors - Demonstrated ability to collaborate effectively across different constituencies - Strong written and oral communication skills

- Ability to influence without authority - Domain knowledge not required, nice to have Accountability- (Specific metrics TBD by mgr) - Campaign performance against goals specified in program business case (.e.g. # leads, cost/ lead

$) - % of campaigns leveraging e-tactics - Campaign response rates (measures creativity / quality of a campaign)

-Bachelor?s Degree in marketing, communications, advertising, or related discipline. -5+ years experience in Marketing Communications in a scientific or technical industry; Life Sciences industry experience preferred. -Minimum of 3+ years direct work experience in a scientific or technical company, managing integrated marketing campaigns with the ability to drive multiple activities concurrently.

-Proven experience managing, leading, driving, and measuring virtual teams toward common goals. -Deep working knowledge of marketing channel best practices with ability to review and optimize the campaign marketing mix.

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-Can function independently with minimal supervision. -Must have excellent verbal and written skills. -Must be a team player, have a positive attitude, and have demonstrated excellence in customer service. -Flexible and willing to change priorities as needed, depending on changes in the business? needs and objectives. -Knowledge of design and visual brand concepts a plus. Geo Location: Wilmington, DE OR Santa Clara, CA Agilent is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to disability, protected veteran status or any other protected categories under all applicable laws.

******************************************************************* See more at:

http://www.wibcareercenter.com/job_summaries?location=San+Francisco%2C+California#sthash.CjQv0wJH.dpuf WIB career listings for San Francisco and San Jose. See for all California cities at http://www.wibcareercenter.com/job_summaries?location=San+Jose%2C+California

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San Francisco, CA - *********************************************************************************

12/14/2014 32

https://jobs.smartbrief.com/action/listing?listingid=EC4E3AB7-6B70-4369-B2B0-D66CE5711161&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 11/19/14 Location: San Francisco, CA Senior Scientist - Cell Engineering Group Pfizer Job Description All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place. Cellular therapeutics, like chimeric antigen receptor (CAR) based T-cells, are demonstrating tremendous

promise in oncology. Pfizer’s increasing commitment to such modalities is underscored by recent collaborations and plans to establish a research group in South San Francisco. This position will be part of this nascent group to help propel Pfizer into this avenue of exciting research and address unmet medical needs.

This scientist will be involved in establishing methodologies, i.e. culturing and activating primary cells, enriching cell populations, and viral transductions and electroporation of primary cells, to generate CAR T-cells. They will also be responsible for testing these CAR T-cells in vitro and in vivo to identify optimal constructs and characteristics for therapeutic uses.

EDUCATION AND EXPERIENCE • PhD degree in Immunology with 0-4 years of experience in biotech or biopharma industry is preferred. TECHNICAL SKILLS REQUIREMENTS • Knowledge and direct experience of modern laboratory methodology in cellular immunology and

molecular biology. • Experience with viral based systems (lentivirus, adenovirus, or murine retrovirus) and genome engineering (zinc fingers, TALEN, or CRISPR) are preferred. • Strong publication record. • Excellent written, oral communication skills.

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable

national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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1F4C7063D6C1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary Date Posted: 12/4/14

Location: Irvine, CA Senior Manager, Clinical Affairs - Advanced Technology Edwards Lifesciences Job Description

As we continue to explore new therapies to help patients worldwide with critical structural heart conditions, we are looking to add to our Advanced Technology clinical research team. We are seeking an experienced Senior Manager, Clinical Affairs with a strong medical device and leadership background.

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Experience in clinical trial management for transcatheter mitral valve repair or replacement therapies is strongly desirable.

As the Sr. Manager of Clinical Affairs, you will be responsible for executing all aspects of clinical trial management for TMVR Clinical Affairs.

May include, but is not limited to FIM, EFS, CE Mark/IDE Trials and Post Market Registries. Collaborate on writing, amending and executing study protocols, reports and all required study

documentation including clinical trial agreements. Manages monitoring operations including device accountability and collaborates with cross-

functional teams (i.e. Biostatistics, Clinical Data Management, Safety, Clinical Specialists) to ensure consistent, compliant and timely execution of the clinical trials to meet corporate goals and adhere to company and regulatory authorities regulations.

Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; resource allocation and planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Required skills and experience: Requires a bachelor's degree in a scientific or related discipline. An advanced degree in a life science, biostatistics or related field preferred. A Professional Health Science certification or designation preferred.

Requires a minimum of 7 years of clinical research experience. Experience in related field or technology, with a minimum of five years managerial level

experience, a track record of personal career development, and clinical trial management experience is required, preferably in medical devices.

Experience in critical care, cardiovascular surgery and/or interventional cardiology a plus. Experience in transcatheter mitral valve repair or replacement technologies or related disciplines is

highly desirable. Advanced knowledge of international regulations of Good Clinical Practice (GCP), experience with

Class II & III medical devices preferred, documented current continuing education in clinical research monitoring (e.g., ACRP/SoCRA) or experience in Clinical Research Project management experience is a must

Strong interpersonal skills are required. Must have demonstrated skills in the following areas:

leadership, coaching and counseling, and strategic clinical trial planning. Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save

and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,200 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair

a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

**********************************************************************************************sensenor Job Summary Date Posted:

11/24/14 Location: San Jose, CA Salary Range: Open

Years Experience: 4 This Job appears in

AdvaMed SmartBrief

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REG AFFAIRS PROJ MGR - 1400000A7F Abbott 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 69,000 people. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship. Follow us on LinkedIn Primary Job Function:

As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is

generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning:

• Develop new regulatory policies, processes and SOPs and train key personnel on them • Evaluate regulatory risks of division policies, processes, procedures

• Provide regulatory input to product lifecycle planning • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory

management • Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes

• Assist in regulatory due diligence for potential and new acquisitions • Utilize technical regulatory skills to propose strategies on complex issues

• Determine submission and approval requirements • Identify emerging issues

• Monitor trade association positions for impact on company products • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

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• Recruit, develop and mentor regulatory professionals Premarket: • Assess the acceptability of quality, preclinical and clinical documentation for submission filing • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions • Compile, prepare, review and submit regulatory submission to authorities • Monitor impact of changing regulations on submission strategies and update internal stakeholders • Monitor applications under regulatory review

• Communicate application progress to internal stakeholders • Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies • Negotiate and interact 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

• Manage and execute preapproval compliance activities Postmarket: • Oversee 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 • Ensure external communications meet regulations

• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events • Actively contribute to the development and functioning of the crisis/issue management program

• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies

• Report adverse events to regulatory agencies and internal stakeholders • Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate);

• Medical writing • Advertising and promotion

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• Labeling • Controlled substances (e.g. DEA) • Restricted substances (e.g. REACH) • Compendial / standards • Import / export • Country specific regulatory support Supervisory / Management Responsibilities: Comments

Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members.

Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently

as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is

reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership:

• Develops, communicates, and builds consensus for operating goals that are in alignment with the division. • Provides leadership by communicating and providing guidance towards achieving department objectives.

• Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

• May lead a cross-functional or cross-divisional project team. • Provides technical leadership to business units.

• Acts as a mentor to less-experienced staff. • Exercises judgment independently.

Planning/Organization: • Creates immediate to long-range plans to carry out objectives established by top management. • Forecasts project related needs including human and material resources and capital expenditures.

Decision Making/Impact: • Assignments are expressed in the form of objectives

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• 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 critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. 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

4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 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

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

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• Write and edit technical documents • Negotiate internally and externally with regulatory agencies • Plan and conduct meetings Cognitive Skills or Ability to: • Pay strong attention to detail • Manage projects • Create project plans and timelines • 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 • Use in-depth knowledge of business functions and cross group dependencies/ relationships

• Define regulatory strategy • Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues

• Perform risk assessment or analysis • Lead functional groups in the development of relevant data to complete a regulatory submission ************************************************************************************

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Job Summary Date Posted: 11/14/14 Location:

Irvine, CA Senior Director Medical Affairs Edwards Lifesciences Job Description The Sr. Director of Medical Affairs will support the $700 million Global Surgical Heart Valve Therapy (HVT)

business unit. The Director will be a seasoned medical affairs professional with strong clinical and scientific acumen and a commitment to putting patients first. The position will be responsible for enabling evidence-based market development of strategic products and therapies through scientific communications and educational modalities developed in collaboration with Key Opinion Leaders (KOLs) and internal

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stakeholders with focus on evidence of value (improved clinical and functional outcomes, quality of life, and health economic benefits), regulatory compliance, and business unit strategy. Responsibilities:

Strategic global leadership of professional education programs – Responsible for the strategy, development, and management of internal and external education programs, selecting and qualifying vendors and faculty, project management, development, and delivery of core curricula.

Publication strategy – Responsible for the advancement of the value proposition of strategic products by developing scientific communications (e.g., abstracts, publications, podium presentations) in collaboration with physician investigators and KOLs.

Collaborate with KOLs to develop innovative training modalities, promote HVT goals, and maintain EW’s leadership position in the market.

Develop HVT policy and procedures (SOPs) for the appropriate conduct of IIS and operationalize a cross-functional IIS process.

Provide program leadership support for the review of clinical aspects of regulatory filings, including technical summaries, labeling statements, IFU, Annual Progress Reports, and Clinical Evaluation Reports.

Provide input and guidance to Marketing on clinical matters to facilitate customer interactions. Qualifications:

MD, PhD, PA or RN, is required. Additional MBA is desirable. Expertise in cardiovascular diseases is preferred.

Minimum of five (5) years experience in clinical practice setting (e.g., hospital, clinic, or academic research section).

Minimum of five (5) years industry experience in medical, clinical, professional education, and/or regulatory affairs.

About Edwards Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save

and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,200 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we

focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Job Function: Clinical Affairs

Primary Location: USA-California-Irvine ******************************************************************* Angel Romero

Global Recruiters of West Palm Beach 561-422-5150 aromero@grnwestpalmbeach.com

Regional Sales Director Asia Pacific/International- CA- # 1535

A Global healthcare diagnostics company that offers specialized molecular diagnostics and EIA diagnostics laboratory testing products to hospitals, commercial laboratories, physicians and public health agencies to assist with the diagnosis, treatment and management of immunology, serology and infectious diseases seeks a Regional Sales Director. Currently, we seek a Regional Sales Director for the Asia Pacific/ International Region based out of California HQs. The Regional Sales Director is responsible for managing

the assigned international region, and the distributor network to maintain and gain incremental business for new and existing products. This position will require moderate to heavy international travel and supports applicable regulations including ISO, Local, State, and/or Federal requirements.

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Key Duties, Activities and Responsibilities: · Directs the implementation and communication of all segment and product sales programs, strategies

and tactics in the assigned sales region. Identifies new sales opportunities through in-depth market and customer understanding.

· Leverages sales opportunities by prioritizing the implementation of sales initiatives. Tracks performance and reports results to supervisor.

· Collaborate with distributors to develop new business and/or to expand existing businesses within the assigned international region.

· Provide leadership to the distributors in the assigned international region to drive consistent and quantifiable results through the distributors managing discipline.

· Direct the implementation and communication of all segment and product sales/marketing programs, strategies and tactics in the assigned region.

· Establish direct relationships with local country opinion leaders and strategic customers in the diagnostics, especially infectious disease arena communities in the assigned international region. Identify, select, and develop new distributors.

· Develop short and long term business plans to drive sustainable growth across all segments within

the European region. · Establishes appropriate territory assignments to effectively meet customers’ requirements and the

needs of the business. · Sets sales objectives for the sales team/distributor in his or her assigned international region

including territory quotas, performance criteria, and professional development initiatives. · Work with assigned field sales team/distributor as coach, manager and leader to maximize customer

satisfaction, employee satisfaction and the achievement of business goals. · Prepare regular analysis of sales and product line trends in assigned region.

· Keep sales team, senior staff and other employees informed of key customer activities. · Reports regional sales results on weekly and monthly basis to supervisor. · Tracks sales/distributor performance to plan and reports results to supervisor. · Prepares monthly sales forecasts.

· Report competitive intelligence to senior staff on an ad hoc basis. · Achieve sales goals by managing/mentoring distributor network to execute a market penetration

strategy to all market segments including large hospitals and commercial laboratories, national account customers, state/public health agencies.

· Sets sales objectives for the distributor including country quotas, product support performance

criteria, and technical expertise development initiatives. · Negotiate pricing agreements that balance the needs of the organization with the needs of the

distributor. · Develop new market in the region by identifying, selecting, and establishing new distributors in the

segment. · Establish effective business relationships with local countries opinion leader and strategic institutions

such that they may serve as referral and/or consultative roles on behalf of the Company. · Assist distributor to increase their technical expertise by providing technical demonstrations/

presentations to their key customers. · Monitor, analyze and recommend response options to strategies and tactics of competitors that serve

to threaten current and future sales of the Company. · Investigate and communicate market development and product development opportunities as

indicated by customers in the market place. Utilize proper channels and systems for submitting such information.

· Manage the assessment of current and future large buyer needs and identify opportunities to expand testing menu and services to meet these needs.

· Provide input regarding identification and selection of promotional tools for the Company. Such items include trade shows to attend, conferences, brochures, catalogs, direct mail campaigns, etc.

· Prepares quarterly sales forecasts. · Prepare regular analysis of sales and product line trends. · Attend local country or international trade shows as required by the Company.

· Actively participate in meetings, training sessions and other sales/marketing planning sessions. · Control selling/marketing expenses.

Work Experience, Skills and Education Required:

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is preferred. · Must have an understanding and experience working in the Asian Pacific Market. · Minimum 10 years related experience and/or training; or equivalent combination of education and

experience in diagnostics IVD sales and experience in doing business in the Asia/Pacific/International region.

· Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.

· Ensure sales quota and business schedules are met. · Regularly interacts with senior management on matters concerning several functional areas,

divisions, and/or customers. · Must possess excellent inter-personal skills and communication. · Demonstrated strategic thinking skills and ability to implement strategic plans. · Experience negotiating contracts with hospitals, health systems, commercial laboratories and

distributors. · Experience in dealing with senior level healthcare executives.

· Demonstrated ability to motivate and manage sales organizations to achieve plan. · Strong written communication and public speaking skills. · Very effective people skills and negotiating ability. · Excellent team player reputation.

· Enthusiastic attitude. · Technically sound understanding of immunology, microbiology & molecular diagnostics. · Sales leader. · Mature, hardworking, flexible, problem solver, decision maker with integrity and a strong standards

of morals. · Self-motivated. · Strong organizational and detail implementation skills. · Computer literate with customer contact management software and Microsoft Office

Sales Account Executive – San Diego –#1796 A leading global fast growing In Vitro diagnostic company and a world technology leader in the development of fast whole blood analyzers is seeking a Sales Account Executive.

Key Duties, Activities and Responsibilities: As a Sales Account Executive, you will be responsible for expanding territory revenues by managing a complex sales process. You will sell the companies’ full range of blood based diagnostic analyzers and POC meters into hospitals and IHNs.

Work Experience, Skills and Education Required:

BA/BS degree Sales experience selling capital equipment into hospitals and laboratories.

Past success calling into multiple points within hospital and/or IHNs is necessary. Experience calling into reference labs will be considered a significant advantage. Your understanding of hospital lab information systems, hospital information systems and

middleware is a plus.

Ideally, you will reside within close proximity of San Diego, CA. Up to 2-3 nights of travel per week is expected.

Global Regulatory Affairs Manager – CA - #1779

A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for a Global Regulatory Affairs Manager. Key Duties, Activities and Responsibilities:

The Manager, Global Regulatory Affairs will be responsible for carrying out logistical activities in relationship to global regulatory submissions for IVD systems (assays, instruments, software). The Manager will also serve as regulatory subject matter expert for design control, development and compliance projects. The Manager will prepare and maintain regulatory documentation for submission to

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US and international regulatory authorities. These submissions may include Biologics License Applications (BLAs) and related Supplements and Amendments, Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs), new registrations, variations, and export notifications, as well as responses to requests for information. This position will also represent Regulatory Affairs on project teams to support new products and projects and provide regulatory strategy, risk assessment, and review of project documents.

Prepare regulatory submissions for US and applicable foreign regulatory bodies for in vitro diagnostic and/or biological products

Global responsibility for representing Regulatory Affairs on design and development, post-approval marketing and partner company project teams

Supervise the activities of regulatory associates as appropriate by product category Formulate regulatory strategy for assigned products and projects Solve problems and make decisions in a cross-functional team setting Manage partner and critical vendor relationships as appropriate to ensure compliant submissions Participate on multidisciplinary teams focusing on continuous improvement and management

initiatives

Demonstrate strong verbal and written communication skills Assume a lead role in the completion of submissions Organize and prioritize work assignments Work independently and closely with colleagues of various responsibilities and educational levels

throughout the company Initiate appropriate actions when individual decisions impact other aspects of the business Review, approve, and track workflows and change controls

Work Experience, Skills and Education Required: Bachelor’s Degree in Life Sciences, Physical Sciences or Engineering required/Master’s Degree

preferred Additional training in Regulatory Affairs (e.g., Graduate or Certification programs) preferred

English required Second language preferred, e.g., Mandarin, Spanish Minimum 5 years of experience in regulatory affairs and/or compliance Experience with developing and obtaining regulatory approvals for biomedical hardware and

software

Knowledge of US FDA and global registration requirements for IVDs and medical devices Knowledge of US FDA Quality Systems regulations, EN ISO 13485, and the EU IVD Directive Strong leadership and mentoring skills Proficient with Microsoft Office software

Outstanding verbal and written communication skills with an ability to foster close and productive working relationships across the organization

Excellent project execution skills with an ability to multitask and prioritize in a fast-paced environment

Global Regulatory Affairs Director/ Sr. Director- CA #1782 A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for a Global

Regulatory Affairs Director for its California location Key Duties, Activities and Responsibilities: The Director, Global Regulatory Affairs will be responsible for directing and managing regulatory project

management and logistical activities in relationship to global regulatory submissions for IVD systems (assays, instruments, software). The Director will also serve as regulatory subject matter expert for design control, development and compliance projects. The Director will be responsible for a group that prepares and maintains regulatory documentation for submission to US and international regulatory authorities. These submissions may include Biologics License Applications (BLAs) and related

Supplements and Amendments, Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs), new registrations, variations, and export notifications, as well as responses to requests for information. This position will supervise representatives of the Regulatory Affairs group on

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project teams to support new products and projects and provide regulatory strategy, risk assessment, and review of project documents, products and R & D programs.

Direct/manage regulatory project management for all regulatory projects in his/her group Direct/ manage/ supervise the preparation of regulatory submissions for US and applicable foreign

regulatory bodies for in vitro diagnostic and/or biological products Global responsibility for representing Regulatory Affairs at Divisional and Business Unit meetings on

design and development, post-approval marketing and partner company project teams Assume a leadership and expert role in the completion of submissions Supervise the activities of regulatory managers and associates as appropriate by product category Formulate regulatory strategy for assigned products and projects Solve problems and make decisions in a cross-functional team setting Supervise the management of key partner and critical vendor relationships as appropriate to

ensure compliant submissions Participate on multidisciplinary teams focusing on continuous improvement and management

initiatives Demonstrate strong verbal and written communication skills

Organize and prioritize work assignments across his/her group Work independently and closely with colleagues of various responsibilities and educational levels

throughout the company Initiate appropriate actions when individual decisions impact other aspects of the business

Provide regulatory counsel for internal and external programs (affiliates) associated with advertising and promotion company products.

Manage projects to budgets and timelines and provide leadership in non clinical, clinical, or other areas.

Participate in review of product changes post approval. Independent reviewer of regulatory applications. Work with regulatory team to develop and implement a promotional review program. Liaison with Marketing/Regulatory/Medical/Sales and Legal (internal) for the review of advertising,

promotion, abstract and scientific papers and presentations. Establish and maintain training program for the regulatory staff.

Work Experience, Skills and Education Required:

Bachelor’s Degree in Life Sciences, Physical Sciences or Engineering required/Master’s Degree

preferred Additional training in Regulatory Affairs (e.g., Graduate or Certification programs) preferred Minimum 7-10 years of experience in regulatory affairs and/or compliance Experience with developing and obtaining regulatory approvals for biomedical hardware and

software Knowledge of US FDA and global registration requirements for IVDs and medical devices Knowledge of US FDA Quality Systems regulations, EN ISO 13485, and the EU IVD Directive Strong leadership and mentoring skills

Proficient with Microsoft Office software Outstanding verbal and written communication skills with an ability to foster close and productive

working relationships across the organization Excellent project execution skills with an ability to multitask and prioritize in a fast-paced

environment Corporate National Accounts Director–CA or Virtual #1777 A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for a

Corporate National Accounts Director-Government executive. The Corporate National Accounts Director-Government plans, develops, and manages long-term relationships with target customer management teams as well as commercial initiatives to achieve or exceed sales targets. This includes development of strategies and plans that identify opportunities in a direct selling market. This position works independently and with the sales team to promote and manage our client’s portfolio of

immunohematology instruments/software and reagents to National Government Accounts groups. Key Duties, Activities and Responsibilities:

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Build strategic customer relationships to foster a long-term relationship that favors our client’s product offerings within the National Government Accounts groups.

Identify account priorities from National Government Accounts groups’ interactions that translate into business strategies. Work with the field sales teams to develop appropriate strategy to meet customer priorities, including a long-term vision for the partnership with the account.

Demonstrate a broad comprehension of the customer's needs, market trends, industry challenges, major players, relevant products and technologies. Bring the breadth of the portfolio, services and solutions, and expertise to the National Government Accounts groups.

Secure and coordinate necessary resources to communicate, deliver, and reinforce our client’s value proposition to the customer.

Develop a detailed account plan/forecast and an operating calendar that serves as the basis for weekly activities for self, and the broader account team.

Maximize, drive and achieve revenue / profit goals and account profitability for assigned accounts. Identify new opportunities that will lead to future sales of strategic and operational importance to

the customer.

Effective use of Budget Allocation and Strategic Planning Effective use and monitoring of all travel and expenses Monitor AR Aging report and ensure customers pay their bills on time Generate Sales Reports including targeted accounts and activities to achieve sales and operating

income targets Contract Compliance

o Ensure customers maintain their Inventory at contractually obligated levels o Generate accurate monthly sales and accrual forecasts

Achieve 100% to plan of annual sales and operating income objectives within the product portfolio Responsible for sales pipeline and forecast to close accuracy

Work Experience, Skills and Education Required:

Bachelors Degree 8 or more years of documented success selling capital equipment to National Government Accounts

Hospital groups. (Selling capital diagnostics to Government Accounts Hospital based labs-

preferred). Evidenced by stack rankings, awards, and commendations. Must be team oriented and work well independently. Prior knowledge of accounts in and around defined territory.

Must have a hunter mentality and experience working in a commission-oriented environment. Strong written and oral communication skills. Ability to manage sales pipeline and budgets. Laboratory/diagnostics experience preferred but not required.

Ability to travel 80-100%; must live near a major airport hub Bio Process Specialist - CA #1663 A global life sciences and medical device manufacturer is seeking a Bio Process Specialist

Key Duties, Activities and Responsibilities:

Adhere to Company Corporate policies; local Quality Manual, Health & Safety, travel and IT policies

Responsible for DSP/USP development within the region. Support current Biotech/Vaccine customers and develop new customers within the region and

other regions as required. Develop strategies (with local management) to maximize the sales opportunities. To educate and advise customers of best suited company technology. To do this, the candidate

must have a good knowledge of companies technologies and develop a common approach of which product to use and where in a Biotech process.

12/14/2014 45

Be a company expert in integrated Biotech/Cell Therapy processes – primary purpose to increase number of applications that have company specified and therefore increase companies sales.

Work in close relationship with the sales representatives (“account manager”) responsible for the account(s) and local SLS team to coordinate and agree the main activities in the respective geographic sales area.

In conjunction with Marketing, identify new Biotech/Cell therapy opportunities ( from pipeline/drug tracking information or company start up level, e.g. new CRO / CMO) Generate sales leads and then review with sales management.

Work with Marketing to track and report progress metrics for penetration of drug and cell therapy pipeline.

Contribute to Sales and Marketing in the planning and presentation of Biotech seminars. Develop expertise by regular pan regional and global communication – exchange of

experiences, applications and technology training. Coordinate the identification and generation of necessary technical documents for internal and

customer use.

Perform and coordinate bench scale test work in conjunction with the SLS Team to demonstrate how to get the best out of companies products.

Work closely and have regular contact with the Level 3 Sales / Technology Specialists to facilitate technical project and/or account handover when appropriate.

To work in close relation with Applications R&D and / or the other teams to assist in the development of companies application platforms in the various Biotech processes.

Contribute to tactical/ strategic plans as requested by commercial. Maintain up to date awareness of relevant technical developments.

Experience and skills to be used anywhere in region. Ability to plan and organize test work Ability to communicate both verbally and in writing Ability to give presentations at conferences, events.

Ability to operate as a member of a multidisciplinary team including sales, marketing, SLS etc.

Knowledge of scientific principles and practices relevant to Biotech customers and processes Knowledge of Industrial fermentation/cell culture, separation or process analytical technologies

is an important added value

Good interpersonal skills to motivate others Ethical and scientific behavior An awareness of the cost effectiveness of individual projects and their resultant financial

implications

Work Experience, Skills and Education Required:

2-3 years minimum relevant experience BA Degree (or equivalent)

Working and traveling outside of normal business hours 50% + travel within U.S., Canada and Latin America Experience in Biotech industry MSc or Higher in Biochemistry, Chemical Engineering or Life Science Bio)/Engineering ( Bio)

Sr Account Manager - CA –#1760 Our client is a rapid growing materials science and engineering company with a broad filtration, separation and purification capabilities. Their process and product enabling technologies help their customers make

good products better, safer and even possible. They provide innovative products to customers in health care, biotechnology, pharmaceutical, semiconductor, municipal, drinking water, aerospace and industrial manufacturing markets. Key Duties, Activities and Responsibilities:

Sells and services company’s products to BioPharmaceutical accounts in assigned sales

territory. Meets or exceeds the territory projections for sales growth. Provides written and verbal communication covering the status of the territory goals and

objectives.

12/14/2014 46

Provides annual Territory Business Plan coinciding with Pall fiscal year. Secures orders from existing and potential customers by means of visiting the customer facility

or contacting by phone. Secures opportunities to quote on customer requirements and follows up on quotations to

secure orders. Provides technical service when appropriate to solve customer problems and assure customer

satisfaction with the company products. Establishes professional customer/vendor relationships with appropriate customer personnel

(purchasing, engineering, manufacturing, quality assurance, management, and other key personnel).

Exceeds minimum required visibility in the field as required by BioPharm West management. Provides annual, quarterly and monthly sales plans and projections to attain required sales

growth and goals as required by management. Can work independently with minimal management intervention to perform and complete

tasks. Capable of mentoring new-hires and less experienced Sales Specialists as required.

Provides written and verbal communication covering the status of the territory goals and objectives in a timely fashion.

Maintains a high degree of technical expertise through product and application knowledge. Performs other safe, legal, ethical duties essential to achieving the business or operational

goals. Work Experience, Skills and Education Required:

BA/BS degree, preferably in a technical area. Five (5) years of outside / inside sales experience.

Excellent communication and interpersonal skills to deal effectively with customers and all levels of the organization

Self-motivated Computer skills in Lotus Notes, Windows and PowerPo

Associate Director, Marketing ( Instrument Systems) #1665 Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major healthcare institutions worldwide. The position is based out of the company’s California headquarters. Key Duties, Activities and Responsibilities:

This role will provide marketing leadership for the systems marketing team and also be responsible for establishing customer facing product positioning for the entire Companies product portfolio. The systems marketing team is responsible for high level product commercial support and portfolio strategy development as it pertains to the NAT analytical systems and pooling products portfolio.

Develop sales tools for use by account managers, and commercial marketing associates for driving

NAT sales. Identify new product concepts and develop business cases for executive management review and

approval.. Create tactical plans to expand, support and protect our global market share. Work closely with the company business partners in order to meet product development

milestones and successful new product launches.

Establish self and team as product experts for NAT systems portfolio. Contribute to establishing, influencing and maintaining a global network including key opinion

leaders and policy makers in the blood and plasma screening market. Develop and implement a consistent brand identity across blood and screening products.

Utilize the Voice of the Customer for validating customer needs. Represent systems marketing team at global industry meetings. Accountable for global marketing deliverables as part of product core teams. Responsible for global launch and rollout of NAT analytic and pooling systems. Overall responsibility for NAT analytical and pooling systems life cycle management.

Work Experience, Skills and Education Required: BS in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA

highly desirable

12/14/2014 47

Minimum of 10 years pharmaceuticals/medical devices/diagnostics industry experience with 4-7 years marketing or marketing-related experience preferred.

Product launch, commercial support and product development experience required. Experience in commercial customer facing role (sales or regional marketing) Comprehensive understanding of the blood screening markets, use of company products, legal and

regulatory issues impacting product marketing Established record getting diagnostic products to market through innovative partnerships and

access programs Ability to take comprehensive scientific data and convert into useful marketing and sales tools Understand global registration requirements in the blood and plasma screening markets Experience presenting to executive management Leadership skills, including the ability to solve problems Persuasive written and verbal communication skills Previous people management experience.

Regional Sales Manager – West Coast –#1797 A leading global fast growing In Vitro diagnostic company and a world technology leader in the

development of fast whole blood analyzers is seeking a Regional Sales Manager. Key Duties, Activities and Responsibilities: In this newly created Regional Sales Manager role, you will be responsible for building and leading a team

of successful Sales Executives and Account Managers. Your team will be dedicated to selling the companies clinical instruments into hospitals and healthcare clinics within your assigned region. Using your well-developed leadership skills, you will effectively manage your team to achieve/exceed your account and sales objective for your region. You will accomplish these goals by hiring top talent and

coaching your team effectively. You will schedule ride-a-longs and work one-on-one with your team members to review: product knowledge, call planning, territory management, relationship building and selling skills. As a successful Regional Sales Manager, you will skillfully manage complex sales cycles and successfully negotiate multi-level committee sales deals, including interfacing with large IHN/GPO

customers. Work Experience, Skills and Education Required:

BA/BS Degree Hands-on experience managing a diverse field sales force Significant capital sales experience

Selling medical devices into hospitals and/or large accounts Exceptional sales skill and leadership ability. Significant overnight travel should be expected.

************************************************************ https://jobs.smartbrief.com/action/listing?listingid=EC4E3AB7-6B70-4369-B2B0-D66CE5711161&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary Date Posted: 11/19/14 Location:

San Francisco, CA Senior Scientist - Cell Engineering Group Pfizer Job Description

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place. Cellular therapeutics, like chimeric antigen receptor (CAR) based T-cells, are demonstrating tremendous

promise in oncology. Pfizer’s increasing commitment to such modalities is underscored by recent collaborations and plans to establish a research group in South San Francisco. This position will be part of this nascent group to help propel Pfizer into this avenue of exciting research and address unmet medical needs.

12/14/2014 48

This scientist will be involved in establishing methodologies, i.e. culturing and activating primary cells, enriching cell populations, and viral transductions and electroporation of primary cells, to generate CAR T-cells. They will also be responsible for testing these CAR T-cells in vitro and in vivo to identify optimal constructs and characteristics for therapeutic uses. EDUCATION AND EXPERIENCE • PhD degree in Immunology with 0-4 years of experience in biotech or biopharma industry is preferred. TECHNICAL SKILLS REQUIREMENTS • Knowledge and direct experience of modern laboratory methodology in cellular immunology and molecular biology. • Experience with viral based systems (lentivirus, adenovirus, or murine retrovirus) and genome engineering (zinc fingers, TALEN, or CRISPR) are preferred. • Strong publication record. • Excellent written, oral communication skills. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or

gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

****************************************************************** Seeking Biotech PR Pros! Nicole LitchfieldCEO of Bioscribe, Inc. - Life Sciences Communications Agency

Bioscribe is hiring biotech PR consultants for either of our Northern or Southern California offices. Life Science Technology and, in particular, Genomics industry experience highly preferred.

LinkedIn | LinkedIn linkedin.com

******************************************************************* Meredith McClanahanRecruitment Services Specialist at BioPhase Solutions

http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=3663

Lab Tech IV BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are recruiting for a Lab Technician IV for our chemical manufacturing client located in Rancho Cordova (SACRAMENTO). This is a contract-to-hire opportunity.

Lab Tech IV Location: San Francisco / Bay Area Type: Contract To Hire Rate: $

Job ID: SF-803

Responsibilities:

Provide analytical chemistry support to multiple projects in accordance with company SOPs and

protocols following GMP guidelines to support plant operations. Take out hazardous waste Re-stock the lab General lab cleaning and upkeep

Review files Check solutions (HPLCs, fridges, etc.) for expired/improperly labeled solutions Utilize or train in analytical chemistry work including: HPLC, FTIR, NMR, Coulormetric KF,

Titrimetric KF, LOD, Moisture analyzer, Densitometer, SMB HPLC

Other Responsibilities may include cage inventory, Data Trending, Hole-punching/stapling forms Log-in samples Preparation of chemical reagents and standards used for the chemical analysis of samples. Performs special projects as assigned

12/14/2014 49

Test and analyze plant and R&D samples within the specified turn-a-round time Requirements:

Bachelor's degree in Chemistry or related field Must be able to work currently day shift with one weekend day. Other shift work may be possible in

the future, and the position requires flexibility to change shifts if needed. Ability to multi-task and function well in a fast-paced environment; and work well with a team. Minimum 6 months-1 year of relevant experience. (Recent grads with strong relevant internships

may be considered. Excellent written and verbal communication Knowledge of cGMP and FDA regulations a plus Strong communication and interpersonal skills necessary for a team-oriented environment Ability to multi-task is mandatory General lab instrument (HPLC, GC, FTIR, NMR and KF) knowledge and operation experience is

preferred but not required Basic computer knowledge, including Microsoft word and excel (used daily) Ability to function well in a team environment

Ability to read and follow written instructions Due to chemical plant security reasons, candidates must either be US Citizens or hold US

Permanent Resident work authorization.

***************************************************************** Jobs That Crossed My Desk Through Nov. 23, 2014

************************************************************* Apply on company website

Associate Director, Validation, Facilities Engineering

Gilead Sciences - Foster City -California -US

Posted 5 days ago

Job description

Specific Responsibilities:

- This position reports into Corporate Facilities and Engineering.

- Provide corporate oversight of Facilities Validation services in Foster City and of global Facilities

projects.

- Ensure all GMP Equipment/Utilities are maintained in a qualified state and proposed changes are

reviewed to determine the validation impact.

- Interacts with other Gilead sites to ensure consistency in application of policies and establish best

practices.

- Drive continuous improvement of the Facilities site Validation program.

- Ensure that internal customers are aligned with the needs and services provided by the validation team.

- Highly experienced in the following Validation areas: Equipment, Facilities & Utilities Qualification and

Computer System Validation

- Experience representing Validation during FDA inspections.

- Strong team leadership, project management and influencing skills

Essential Duties and Job Functions:

-Manages validation department, including organizing and prioritizing departmental goals and objectives,

performing training, and writing performance reviews for direct reports.

- Oversees the completion of projects through the development and approval of validation schedules,

project plans, master plans, validation protocols and reports for systems that may be complex in nature to

support clinical and commercial manufacturing.

- Manages validation activities with Development, Manufacturing, Engineering, Quality, and other groups

on projects.

- Manages the activities of assigned validation and contract personnel to ensure the quality of completed

work.

12/14/2014 50

- Provides technical assessment and validation approval for engineering and process changes.

-Reviews and approves protocols, reports and data tables generated by subordinates and contract

personnel.

-As required, prepares regulatory submissions and presents validations to regulatory authorities during

routine internal and pre-approval inspections.

- Ensures solutions are consistent with organizational objectives.

-Leads compliance audits as required. Interfaces with contract manufacturers to address documentation

and compliance issues.

- Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.)

as needed.

Knowledge, Experience and Skills:

-Broad knowledge of GMP principles, concepts, practices and standards in the US and internationally.

-Able to develop and improve concepts, techniques, and standards.

-Develops new applications based on quality principles and theories.

-Able to provide solutions to highly complex problems, which require a high degree of ingenuity, creativity

and innovativeness.

-Able to manage challenges, which are unique and provide solutions that may serve as precedent for

future decisions.

-Interprets, executes, and recommends modifications to company-wide policies to achieve corporate goals

and objectives.

-Comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in

public forums.

-Develops budgets and monitors expenditures.

Typically requires,

- 12+ years of relevant experience and bachelor’s degree in science or related field.

-10+ years of relevant experience and a MS or MBA.

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to

the workplace every day, you will be part of a team that is changing the world and helping millions of

people live healthier, more fulfilling lives. Our worldwide staff of more than 7,000 people is a close

community where you can see the tangible results of your contributions, where every individual matters,

and everyone has a chance to enhance their skills through ongoing development.

Our scientific focus has resulted in 16 marketed products that are benefitting hundreds of thousands of

people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure

medications are available to those who could otherwise not afford them.

Today, Gilead's research and development effort is the largest it has ever been and includes

approximately 200 clinical studies evaluating compounds with the potential to become the next generation

of innovative therapies for HIV/AIDS, liver diseases, serious respiratory and cardiovascular conditions,

cancer and inflammation.

The commercial success of Gilead's portfolio of 16 products has provided the company with the resources

to support the development of new therapeutic advancements.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and fast-

paced environment while working with highly-respected teams.

We would like to invite you to be a part of the following Gilead organizations that have helped millions of

people around the world live healthier and more fulfilling lives. ***********************************************************************************

12/14/2014 51

Medical Device Sr. Product Manager – Cardiovascular San Francisco Bay Area

Miranda AshmanBiotech Marketing Recruiter at The Alpine Group

http://youtu.be/tq5hcg4Bydw

A high-growth medical device company in the San Francisco Bay are is expanding its marketing

department and is adding a Senior Product Manager to develop marketing strategies for a high profile

and successful product line in the cardiovascular space.

Requirements:

• 7+ years of total work experience in the medical technology industry

• 3+ years of in-house marketing experience in the medical device industry

• Bachelor’s degree or better is required; MBA is preferred

If you or someone you know is qualified and interested please contact me privately at

miranda@alpinesearch.net

Thanks!

Miranda Ashman

The Alpine Group **********************************************************************

Apply on company website

Sales Representative - Burbank, CA (T0083) - Team 2

Takeda Pharmaceuticals - Burbank, CA

Posted 4 days ago

Job description

OBJECTIVE:

The Takeda Sales Representative is a sales professional responsible for selling different products from the

company’s portfolio of marketed products. This is achieved through a disciplined sales approach based on

strategic planning and persuasive selling skills that engages targeted healthcare professionals in relevant

clinical discussions aimed at identifying appropriate patients in order to maximize product utilization within

a specific geography.

ACCOUNTABILITIES:

Meet or exceed sales goals on a monthly, quarterly, and annual basis.

Pre-call plan to identify sales opportunities meet health care professionals' (HCP) needs. Leverage

data and customer knowledge to build product discussions around HCP's and patients’ needs. Deliver

accurate and timely follow-up discussions with HCP’s and office staff. Foster ongoing trust with HCPs.

Use the Takeda Selling Model, to influence the HCP decision making process.

Utilize effective selling skills and product knowledge to persuade targeted health care professionals

to prescribe Takeda promoted products. Execute brand strategies to ensure a consistent company sales

and marketing message.

Analyze territory information to optimize routing and achieve sales results. Monitor local market

conditions for changes that impact business.

Utilize sales tools, resources and supporting analysis to plan activity. Develop and execute plans to

maximize selling resources.

Report and monitor sample and literature use, and maintain accurate records.

Distribute product samples in accordance with approved sampling guidelines and marketing

literature to physicians and other healthcare providers (HCP’s).

Collaborate with partners on routing and resource utilization to maximize overall footprint

performance.

12/14/2014 52

Provide feedback to District Managers on market place trends, challenges, programs, response to

promotion, and product access. Collaborate with DM to establish goals and implement plans to enhance

current skill sets and sales results.

Attend all company-sponsored sales and medical meetings as directed by company management.

Actively pursue continuous learning and professional development on efficient sales,

communication & product knowledge training.

Perform Company business in accordance with all regulations, Company policy and procedures.

Demonstrate high ethical and professional standards at all times.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS:

Required:

Bachelor’s degree

Proficient in MS Office Suite

Preferred:

Outside, Business to Business (B2B) sales experience

Demonstrated experience with self directed learning

Ability to learn and articulate complex scientific material

LICENSES/CERTIFICATIONS:

Valid driver's license required.

PHYSICAL DEMANDS:

Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

Carrying, handling and reaching for objects.

Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

Ability to drive to or fly to various meetings/client sites.

Overnight travel required based on territory needs.

Ability to attend sales meetings at off-site locations.

We are driven to improve people's lives.

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information,

visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

About this company

For more than 230 years, Takeda has been serving society with innovative medicines, helping patients

reclaim valuable moments of life from illness. Now, with new healthcare solutions from prevention to care

and cure, we are determined to help even more people enjoy their lives to the fullest.

Our mission is simple: we strive toward better health for patients worldwide through leading innovation in

medicine.

This mission:

12/14/2014 53

At Takeda, our passion for healthcare and commitment to improving lives will enable us to make the next

230 years healthier and brighter for people around the world. Our robust product pipeline is focused on

treating serious diseases and disorders, including bone and joint disorders, cardiovascular disease, central

nervous system disorders, chronic kidney disease, diabetes, gastroenterology, gynecological disorders and

infectious disease. *********************************************************** Apply on company website

Territory Business Manager

Zoetis US - California, USA

Posted 5 days ago

Job description

Zoetis, formerly a business unit of Pfizer, is a leading global animal health company dedicated to

discovering, developing, manufacturing and commercializing a diverse portfolio of animal health medicines

and vaccines to meet the needs of veterinarians and the livestock farmers and companion animal owners.

Our Vision is for our products, services and people will be the most valued by animal health customers

around the world. Our mission is built on a six-decade history and singular focus on animal health to bring

customers quality products, services and a commitment to their businesses.

Zoetis is a $4.6B Animal Health business, where our products are sold in 120 countries globally. We have

approximately 9,800 colleagues globally across diverse skills, capabilities functions, including, field force,

research and development, manufacturing, and various global functions supporting our businesses

globally.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and

job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or

gender expression, national origin, disability or veteran status.

Manage the Zoetis, Inc Dairy & Equine business with Distributors, Veterinarians, Dealers, and Producers in

the Chino, CA Area. It will be advantageous for the person in this position to understand the Dairy &

Equine markets. The position will require some travel & nights away from home(20% travel).

Responsibilities:

The Territory Manager, Cattle and Equine, under general supervision, will be responsible for:

- Calling on Dairy producers, veterinarians, dealers, and distributor representatives and being able to

quantify and qualify differences among Zoetis, Inc products and those of our competitors.

- Utilizing excellent presentation skills to conduct educational training and exhibiting selling skills at

accounts and producer seminars.

- Articulate industry insights relevant to the customer need to create value for the customers business.

- Building relationships and influence within key trade channels including: veterinarians, distributors,

extension and university personnel.

- Managing a broad geographic area with a diverse customer base to achieve sales targets and objectives.

12/14/2014 54

- Performing other duties and responsibilities as assigned and directed.

Qualifications

- A Bachelor degree or higher preferred.

- A minimum of 2 years of cattle related experience

- Excellent oral, written and verbal communication skills

- Proficiency with computer applications including Microsoft Outlook, Excel and Word

Full time

Regular

Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and

job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or

gender expression, national origin, disability or veteran status or any other protected classification. Zoetis

also complies with all applicable national, state and local laws governing nondiscrimination in employment

as well as employment eligibility verification requirements of the Immigration and Nationality Act. All

applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and

exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and

employment eligibility, considering factors such as availability of qualified US workers. Individuals

requiring sponsorship must disclose this fact.

About Us

Join Zoetis - and build your career with a global animal health company dedicated to supporting its

customers and their businesses.

Why Zoetis

Zoetis has more than 60 years of experience in delivering innovative, high-quality products and services

that benefit our customers.

Zoetis work environment

At Zoetis, we take pride in a collaborative spirit and high-performing environment where every colleague

is given room to learn and grow.

Your opportunities at Zoetis

We invest in our people and offer diverse and exciting opportunities to make a difference in a growing

global industry while shaping the future of animal health.

Results that matter

Our colleagues make an impact by working hand-in-hand with those who raise and care for animals to

better understand and address the unique real-world challenges they face.

**************************************************************************** Apply on company website

Sales Representative, Primary Care Sales - Palm Springs CA 1

Daiichi Sankyo, Inc. - Palm Springs, CA

Posted 19 days ago

12/14/2014 55

Job description

Job Summary:

Calls on health care professionals in assigned sales territory and communicates product advantages,

features and benefits, plays a vital role in fostering the Company’s reputation and image. Is responsible

for selling and promoting Daiichi Sankyo products in a highly professional, ethical and knowledgeable

manner.

Requirements:

Achieves or exceeds sales objectives in assigned territory.

Builds relationships with physicians and key thought leaders and influencing physicians and healthcare

providers to prescribe Daiichi Sankyo promoted products. Analyzes customer needs and interests.

Complies with applicable laws in providing physicians with pharmaceutical samples and literature.

Represents the Company in a highly professional and ethical manner, and fosters the Company’s

reputation and image. Continually enhances product and disease state knowledge by participating in

assigned training and completing outside reading. Serves as a disease state expert and provides a high

level of product expertise and customer service for all accounts. Carries out all sales and marketing

programs including occasional evening and weekend events in the approved manner. Maintains all

equipment and territorial records in the prescribed manner. Utilizes sales force automation system and

other equipment to enhance impact of sales call and territory management. Transports materials

(samples, visual aids, audio visual and other electronic equipment) up to 25 pounds into physician’s office.

Education and Experience Requirements:

BS/BA. Sales experience preferred.

Daiichi Sankyo, Inc. is an Equal Opportunity Employer - M/F/D/V

About this company Follow company

Daiichi Sankyo, Inc. headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo,

Co., Ltd. and a member of the Daiichi Sankyo Group. Global clinical development and regulatory activities

are headquartered at Daiichi Sankyo Pharma Development in Edison, New Jersey. Daiichi Sankyo, Inc.

was formed in 2006 from the integration of two leading pharmaceutical companies, Sankyo Pharma, Inc.

and Daiichi Pharmaceutical Corporation. Our team of nearly 2,500 U.S. employees is dedicated to the

creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs.

We currently market therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome and

metastatic melanoma.

For more information on our careers, please visit www.dsicareers.com ******************************************************************** Apply on company website

Senior Territory Business Manager - Immunoscience - Beverly Hills, CA

Bristol-Myers Squibb - NA-US-CA-Los Angeles

Posted 4 days ago

Job description

Bristol-Myers Squibb is a global biopharmaceutical company committed to a single Mission – to discover,

develop and deliver innovative medicines that help patients prevail over serious diseases. We are building

our talent pipeline in Orencia Sales and we are looking for smart, driven and passionate people, who want

to make a difference in the lives of patients.

Understands and applies knowledge of health care industry, trends, applicable laws and regulations,

market conditions, and the managed health care environment into business plans and in daily execution of

12/14/2014 56

sales calls within compliance guidelines.

Develops and implements territory plans that properly identify and prioritize activities to accomplish short

and long term business plan goals.

Demonstrates clear and thorough understanding of disease states, BMS products and relevant competitor

products, including their mechanisms of action, indications, efficacy, safety, etc.

Collaborates with territory matrix team on identifying opportunities and developing appropriate tactics and

strategies.

Builds and maintains strong professional relationships with physicians in private practice, medical group

practices and or hospitals, office staffs and others in the patient care continuum.

Fosters team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and

information.

Drives market share growth and maximizes sales performance within the indicated use and for the

approved patients.

QUALIFICATIONS

• The successful candidate must have a bachelor’s degree or equivalent with minimum of 3 years of

Pharmaceutical Sales Representative experience.

• Demonstrated strong sales performance track record.

• Demonstrated understanding of the business drivers, dynamics, regulations and managed health care

within the pharmaceutical industry.

• Demonstrated skills at building and maintaining professional relationships with key customers, office

staff and others in the customer influence network.

• Effectively use active listening, probing and other selling skills to enhance communication, build and

influence key customers.

• Demonstrated ability to analyze, develop and execute business plans.

• Demonstrated ability to work in matrix teams.

• Demonstrated track record of developing self to drive and enhance performance.

• Account management skills and experience in the buy and bill market is preferred.

As this position requires operation of a Company-provided vehicle, candidates must meet the

requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not

limited to the following: 1) at least 21 years of age; 2) a driver’s licensed in good standing issued by your

state of residence; and, 3) a driving risk level deemed acceptable by the Company.

About this company Follow company

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and

deliver innovative medicines that help patients prevail against serious diseases. Around the world, our

medicines are helping millions of patients in their fight against such diseases as cancer, cardiovascular

12/14/2014 57

disease, diabetes, hepatitis B, HIV/AIDS, psychiatric disorders and rheumatoid arthritis. Additionally, our

philanthropic programs have given new hope to some of the world's most vulnerable communities and the

preservation of our natural resources represents one of our key commitments.

Our BioPharma strategy uniquely combines the best elements of a traditional pharmaceutical company

with the entrepreneurial spirit and agility of a leading-edge biotech company - and our strategy is

working. Since 2002, we have delivered 13 key new products to patients with serious diseases, four of

these medicines are biologic products, and our pipeline continues to deliver. In 2011, we received

approvals for three new medicines - an impressive number for a single year; and we outperformed most

big pharma companies, diversified companies and pure biotech companies. Additional biologic compounds

- as well as scores of other investigational medicines - are advancing through our development pipeline

and we are recognized as having one of the most productive pipelines in the industry.

Please Note: Bristol-Myers Squibb is not responsible for any content that third parties may post herein.

Recent Updates ************************************************************************ https://www.linkedin.com/jobs2/view/12374910?trk=job_view_similar_jobs

Pharmaceutical Sales Representative - Renal Long Beach, CA 7103

Quintiles - Long Beach, US-CA

Posted 1 day ago

Job description

Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical

development and commercial outsourcing services. With a network of more than 30,000 employees

conducting business in 100 countries, we helped develop or commercialize all of 2013’s Top 100 best-

selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with

extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly

complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of

better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com

We are excited to announce that we have partnered with a top pharmaceutical company and at this time

we are looking for Pharmaceutical Sales Representatives to add to this exciting long-term partnership.

Pharmaceutical Sales Representative – Renal

The primary objective of the sale 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.

Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including

medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k).

We look forward to the prospect of working with you! Please apply on-line at: www.quintiles.com

EEO Minorities/Females/Protected Veterans/Disabled

12/14/2014 58

Desired Skills and Experience

Qualifications/Experience

4 year Bachelor’s degree from an accredited University required

Sales professionals to have at least 5 years pharmaceutical sales with a minimum of 2 years of

specialty sales with proven successful sales and/or related experience in highly competitive markets

Renal sales experience preferred

Pharmaceutical sales with account management experience required.

Ability to travel as necessary is required

Valid driver’s license that meets with Quintiles driving standards is required

Residence within the current geography is required

Competencies

Ability to handle ambiguity while compliantly driving results

Demonstrated performance and results orientation across multiple career assignments

Demonstrated customer and marketplace expertise, including clinical expertise and local market

access conditions

Ability to uncover local/regional patient flow, inclusive of institutions, pharmacy and retail settings

Ability to effectively build successful territory business plans to ensure successful product launches.

Professional credibility; demonstrated success in persuasion, influence and negotiation skills

Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge

Proficient with the selling process, inclusive of local managed care dynamics and patient support

programs

Initiative & execution-oriented

Collaboration; Customer Focused with ability to identify, develop and leverage relationships

Team player

***************************************************************** https://www.linkedin.com/jobs2/view/12352005?trk=job_view_similar_jobs

Pharmaceutical Sales Representative (Primary Care) - Palm Springs, CA

Forest Laboratories, Inc. - Palm Springs, US-CA

Posted 2 days ago

Job description

Job ID: 2438

Position Description:

As a pharmaceutical Sales Representative, you will have the opportunity to regularly call on health care

professionals (primary care physicians, clinics, hospitals and pharmacies) within a specific geographic

area. Day-to-day responsibilities consist of supporting the promotional efforts behind Forest products,

which includes organizing, tracking and distributing FDA regulated sample products to health care

professionals. You will maintain a current and competent level of knowledge on the product line to be a

reliable source of information to the health care professionals in the territory.

Position Requirements:

Basic Qualifications

Bachelors degree is required.

12/14/2014 59

Candidates should possess a minimum of 1 year of experience in outside business to business sales

with a proven track record of success.

Ability to work both independently and in a team setting towards meeting established objectives.

Well-developed written and oral communication skills.

Applies a range of traditional and non-traditional problem-solving techniques to think through and

solve issues creatively to improve performance and company effectiveness.

Ability to build rapport and relationships by interacting effectively with employees and external

contacts (i.e. MD and office staff) at all levels, demonstrating the awareness of their needs and

responding with the appropriate action.

Highly effective organizational skills to implement a variety of programs, such as speaker programs

and other activities.

Computer Skills; Word, PowerPoint, Excel and Outlook.

Some overnight travel may be required.

Candidates must be able to successfully pass background, motor and drug screen investigations.

Preferred Skills/Qualifications

Experience in the healthcare industry involving interaction with physicians, patients, etc. Experience in

educating or influencing targeted customers.

45110504 - Palm Springs, CA

We are an Equal Opportunity Employer and do not discriminate

against applicants due to race, ethnicity, gender, veteran status,

or on the basis of disability or any other federal, state or local protected class. .

************************************************************************ https://www.linkedin.com/jobs2/view/12375846?trk=eml-b2_anet_digest-group_jobs-80-job-13&midToken=AQGaiMVDok902Q

Specialty Pharmaceutical Sales Representative

GrantProSearch - Long Beach, CA

Posted 1 day ago

Job description

This Pharmaceutical specialty company is looking for a highly driven pharmaceutical sales professional

who is passionate about selling with a positive attitude and solid work ethic. The pharmaceutical sales

representative will call on specialty physicians in Long Beach/ Torrance including Fullerton and Downey.

Prefer candidates with CNS experience or calling on neurologist or psychartist, HIGH

PERFORMANCE=HIGH REWARD

Candidate salary will be based on expereince.

Desired Skills and Experience

BA/BS required.

2-5 years extremely successful pharmaceutical sales experience candidate. Candidates with nework

in the CNS market with neurologist preferred.

Candidate must have documented sales success including consistent record of performance.

Looking for competitive team player. Candidate must be DRIVEN.

Must have STABLE employment background- NO JOB HOPPING!

Must be great team player and communicator.

Must be able to show great business acumen and be accountable.

Must show ability to be clinically astute.

About this company

12/14/2014 60

Follow company

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. *********************************************************************** Contact Joyce Chiarenza at Chiarenzaj@aol.com Let Joyce know if you are interested and she will send all resumes to hiring manager. Chiarenza Consulting, L.L.C. Regulatory Affairs and Labeling Expert Clinical Compliance Certified Professional Joyce L Chiarenza, CCCP 1773 Hull Ave Redwood City, CA 94061-3401 Best Way to Reach Me: 650-364-3980

JOB PROFILE Click here to view Job Profile Example Name of Role Quality Control Manager Name of Team i.e. small group, project team, BoB

Recothrom Team

Name of Organization i.e. Medical Office, Engage

Quality Assurance

Location City, State or Country (location of job)

Redwood City, CA

Accountable to Leader candidate will be directly aligned to

Sr. Director QA Redwood City

Role Summary (high level summary)

(individual role details and activities they will be performing)

Accountable for: Assuring GMP compliance of analytical and

microbiological testing activities at the Recothrom suppliers through testing documentation review and feedback to the suppliers to meet the requirements of 21 CFR 210 and 211 and 600. Responsible for: This position is responsible for Quality Control oversight of the Recothrom analytical testing including raw materials, in-process, bulk and final product release and stability testing

Deliverables

to accomplish?

Review and feedback to Contract testing

suppliers on QC testing documentation for GMP compliance and technical correctness to include:

Raw materials and components In-process testing Lot release testing and certificate of analysis Stability testing

Investigational studies New test method validation Method transfers

12/14/2014 61

Specification test result events associated with testing and initiate a Discrepancy if applicable to document the Recothrom evaluation.

revised specifications. Track status of the CCR and compile CCR files. Provide early notice to suppliers of the proposed change associated with testing to obtain their input.

Requests (CCR) for impact to testing.

and analytical equipment protocols and reports.

laboratories) Qualification and oversight program, and perform supplier audits for testing laboratories

The information below is needed to benchmark the role. Role Requirements Knowledge, Skills & Abilities Management/communications with Contract Testing

Laboratories , familiar with method transfer/qualification and validation requirements, analytical instrument qualification, calibration and maintenance, testing requirements for raw

materials, components, pharmaceutical products and stability, OOS and deviation investigations, generation of QC documentation such as SOPs, computer skills with MS WORD, EXCEL, Power Point

and Visio. Good interpersonal communication and written skills.

Work Experience:

5+ years’ experience in pharmaceutical Quality Control organizations

Educational Background:

BA or BS required preferable in chemistry or biochemistry

______________________________________________________________ JOB PROFILE Click here to view Job Profile Example Name of Role Quality Assurance Manager

Name of Team i.e. small group, project team, BoB

Recothrom

Name of Organization i.e. Medical Office, Engage

Quality Assurance

Location City, State or Country (location of job)

Redwood City, CA

Accountable to Leader candidate will be directly aligned to

Sr. Director Quality Assurance, Redwood City

Role Summary (high level summary) (individual role details and

activities they will be performing)

Accountable for: For Quality Assurance compliance of Recothrom manufacture and testing to meet the United States Quality Regulations (21 CFR 210/211-drugs and 21 CFR 600 biological products and comparable outside

US (OUS) quality system and compliance requirements as required. Responsible for: This position is responsible for participating in the management of the Quality

12/14/2014 62

Systems to assure GMP compliance and product quality of manufacturing activities at the suppliers for Recothrom

Deliverables

to accomplish?

Perform the following activities and assure timely turnaround.

review (GMP Compliance, oversight of technical reviewers, generation of lot trace, etc.) and management for:

Drug Master Batch Records and executed batch records Compliance documents (COC and COA)

commercial distribution.

Requests (CCR) associated with Recothrom and coordination/track CCR implementation actions to facilitate completion of the CCR files.

Manufacturing/testing and Raw Material/Components) Qualification and oversight program, and perform supplier audits

document reviews and participate as a QA approver for documents such as Recothrom supplier deviation

The information below is needed to benchmark the role. Role Requirements Knowledge, Skills & Abilities Management of GMP Quality Systems, Supplier

Quality oversight, generation of QA documentation

such as SOPs, investigational reports, computer skills with MS WORD, EXCEL, Power Point and Visio. Good interpersonal communication and

*

************************************************************************* *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** 32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32-

biotech-and-biopharma-recruiters/77900088/?page=1 ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and

author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ********************************************************************

12/14/2014 63

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/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf See most recent Beyond borders: unlocking value Global biotechnology report 2014 At http://www.ey.com/GL/en/Industries/Life-Sciences/EY-beyond-borders-unlocking-value ***************************************************************

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 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

12/14/2014 64

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 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.

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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. 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 caldwell@biotechink.com, 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

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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 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. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

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” • enewsletters@fdanews.com 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 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 wd_darshana@hotmail.com. 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.

12/14/2014 67

************************************************************************* 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/38033/title/2013-Life-Sciences-Salary-Survey/

Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies. The fifteenth survey is available at http://www.contractpharma.com/contents/view_salary-survey/2014-06-05/2014-fifteenth-annual-salary-and-job-satisfaction-/

The most recent salary survey in medtech is “Medtech Salary Survey 2013: A Sneak Peek” by Jamie Hartford, posted in Medical Device Business, Nov. 5, 2013. See snapshot at http://www.mddionline.com/article/medtech-salary-survey-2013-sneak-peek See additional comments in report dated Nov. 27, 2013.

This year’s annual Medical, Marketing and Media salary survey was released in October 2014. The article entitled “Career and Salary Survey: In Check,” Oct. 2014 is found at http://editiondigital.net/publication/frame.php?i=226938&p=&pn=&ver=flex

You can download the Premium Edition in pdf at http://media.mmm-online.com/documents/93/css_2014_premium_edition_23196.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 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

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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 audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************