This document discusses medical writing and the role of medical writers. It defines medical writing as the activity of producing scientific documentation by a professionally competent writer who was not directly involved in the underlying research. Medical writers present scientific information to different target audiences in a clear and understandable way. There is increasing demand for medical writing from the pharmaceutical industry and medical institutions to communicate medical research effectively. The document outlines the types of medical writers and their roles in regulatory writing and educational writing. It also lists the skills required of a medical writer and examples of major medical writing organizations and services provided.

1. By: Dr. Reshma Kotian

2. Medical Writing
 Medical 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.

3. Need for Medical Writing
 Pharmaceutical 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.

4. 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.

5. Regulatory Writing
IB CSR PSUR
CTD PI Protocol

6. Educational writing
Advertisement Journal Article
Brand
promotion
doc
Training
Materials for
CT Team
Teaching
material for
sales team

8. SKILLS OF A MEDICAL WRITER
Understanding Of Basic Medical
Terminologies
Educational Qualification
Basic Computer Knowledge
Good Writing and Word processing
Skills
Ability to provide Customized Writing

9. Ability to meet deadlines
Research continuously for new Info.
Data Accuracy
Conciseness
Logical Information
Readability

10. Dictionaries and Coding in
Pharmacovigilance
ICD
SNOMED
WHO-drug dictionary
ATC codes
EudraVigilance
MedDRA

11. MedDRA

12. What happens on an
organisation level
Survey
Lead
Generation
Proposal
Plan and
Implement

14. Hierarchy
Editor
Sub Editor
Sr. Medical
Writers
Jr. Medical Writers

15. Services
Regulatory 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

17. Major Medical writing
Organisations
AMWA`
UNIV.
OF
PHILAD
ELPHIA
AMWA
IMWARMWA
SOMW
EMWA

18. 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.

19. THANK YOU