medical writing organisation
TRANSCRIPT
Medical Writing Organisation
By: Dr. Reshma Kotian
Medical WritingMedical Writing is the activity of producing scientific
documentation by a professionally competent writer.
The medical writer typically is not one of the scientists or
doctors who performed the research but the scientific
information in these documents needs to be presented to suit
the level of understanding of the target audience, namely,
patients or general public, physicians or the regulators.
Need for Medical WritingPharmaceutical industry recognized that it requires special skill to
produce well-structured documents that present information clearly
and concisely.
A demand for the clear articulation of medical science, drives the
demand for well written, standards-compliant documents that
medical professionals can easily and quickly read and understand.
Similarly, medical institutions engage in translational research, and
some medical writers have experience offering writing support to the
principal investigators for grant applications and specialized
publications.
Types of Medical writers
[1] Scientific Writing [ Regulatory]
• Scientific medical writers are those who have a degree in Medicine,
Pharmacy and/or Science• Example, CT documents like protocol, IB, Trial reports etc.• MedDRA
[2] Marketing Writing [Educational]
• Marketing Medical writers (Medico-marketing writers) are those who
need not have a medical/science background. A degree in
Journalism/ English may suffice.• Example, Patient education materials, training manuals, advertising
copies etc.
Regulatory Writing
IB CSR
PSUR CTD
Educational writingAdvertisement Journal
Article Brand promotion doc
SKILLS OF A MEDICAL WRITERUnderstanding Of Basic Medical Terminologies
Educational Qualification
Basic Computer Knowledge
Good Writing and Word processing Skills
Ability to provide Customized Writing
Ability to meet deadlines
Research continuously for new Info.
Data Accuracy
Conciseness
Logical Information
Readability
Dictionaries and Coding in PharmacovigilanceICD
SNOMED
WHO-drug dictionary
ATC codes
EudraVigilance
MedDRA
MedDRA
What happens on an organisation level
Survey Lead Generation Proposal
Plan and Implement
HierarchyEditor
Sub Editor
Sr. Medical Writers
Jr. Medical Writers
ServicesRegulatory writing services Clinical study report (full, abbreviated or synoptic, ICH E3-compliant CSR) Clinical study report appendices Clinical study protocol and protocol amendment Investigator’s brochure (IB) Patient narratives Safety update report IND documents New Drug Applications/Marketing Authorisation Applications (NDA/MAA) summary documents
(eCTD modules 2.5 and 2.7) Data Safety Management Board (DSMB) reports Clinical development plan Top-line results report Informed consent form All these documents can be tailored to fit requirements for your paper and e-submission packages.Medical communication services Abstract Publication Poster Slide presentation
Major Medical writing OrganisationsAMWA`
UNIV. OF PHILADELPHIA
AMWA
IMWARMWA
SOMW
EMWA
Current Scenario
In the current scenario, medical writing agencies has
been emerging as a backbone of various
biopharmaceutical organizations and CROs who
prefer to outsource their medical writing profile for
better quality work with assured business success in
stipulated time period.
THANK YOU