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Medical Writing

This document discusses different types of medical writing and the roles and responsibilities of medical writers. It outlines that regulatory writers prepare documents like clinical study reports and investigator brochures, while publications writers develop publication plans and prepare manuscripts from clinical trial data. Both roles require familiarity with guidelines and software. Qualities of a good medical writer include enthusiasm for writing, ability to synthesize data, communicate clearly, and have a scientific background. Medical writers must be prepared to have documents edited extensively and not expect authorship on publications.

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nicky02
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2K views

Medical Writing

This document discusses different types of medical writing and the roles and responsibilities of medical writers. It outlines that regulatory writers prepare documents like clinical study reports and investigator brochures, while publications writers develop publication plans and prepare manuscripts from clinical trial data. Both roles require familiarity with guidelines and software. Qualities of a good medical writer include enthusiasm for writing, ability to synthesize data, communicate clearly, and have a scientific background. Medical writers must be prepared to have documents edited extensively and not expect authorship on publications.

Uploaded by

nicky02
Copyright
© Public Domain
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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MEDICAL WRITING

vFunctions????????
v Publications writing

v Regulatory writing

v SOPs and manuals


v Publications writers do……
vPrepare manuscripts, abstracts, posters,
slide
presentations from CR&D trial data
vDevelop strategic publications plans
vChair publication subcommittees
vCoordinate review and sign off of CR&D
publications
vCoordinate agency and freelance
publications support
vDo not write regulatory documents (CSRs,
etc)
vRegulatory writers do………..
v Prepare Clinical Study Reports, Investigator
Brochures, Summary Documents, Labeling

v Become familiar with pertinent guidelines and


regulations and company SOPs

v Become capable in relevant software applications,


especially word and word templates

v Develop understanding of how documents relate to


one another, a skill that aids in document planning and
preparation
v Attend meetings, serve on committees
vWriting for Compliance…………

vStandard operating procedures,


document preparation manuals,
training materials…….
What Qualities needed for Medical
Writing ?
vEnthusiasm for writing - willingness to go the
extra mile
vAbility to gather, synthesize and critically analyze
large amounts of data
vExpress ideas succinctly – not “academic”
documents
vGood team player
vScientific/medical background
vExpertise in 1or 2 therapeutic areas plus
willingness to learn from others
vBe prepared to have document severely “edited”
by team members or investigators
vDo not expect to be an author when manuscript is
published
vFreelancers
vShould be able to attend meetings by Management.
vShould be willing to commit to a series of related
manuscripts/documents
vSense of humor
vWhat Is Expected?
vAs a Medical Writer, you spend as much time
chasing
down details, and reconciling discrepancies
as you do
actually writing;
vYou must have a thick skin and learn not to
take criticism of your writing personally;
vYou must be able to communicate with many
professionals from many functional
disciplines;
vYou're the last one to get the information,
and are often expected to work miracles in
vYou must keep up-to-date with the software used;
vIf you are freelancing, you must be willing to keep
the software on your PC up-to-date;
vYou must be willing to ask questions;
assumptions can result in time wasted;
vYou must be knowledgeable about processes and
style guides.
vAs a Medical Writer, you need to keep current with
your therapeutic area(s).

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