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