Medical Writing in the Pharmaceutical Industry
When I think of medical writing in pharma/biotech, I typically divide it into two types of writing:
- regulatory/clinical
- scientific communications
The regulatory/clinical writing includes composing documents including:
- clinical trial protocols
- informed consent forms (ICFs)
- clinical study reports (CSRs)
- briefing documents for regulatory submissions
- regulatory submissions such as Investigational New Drug applications (INDs), Clinical Trial Authorizations (CTAs)
Scientific Communications writing focuses more on:
- abstracts & posters
- publications (peer-reviewed journals, review articles, etc)
The medical writing function can be “in-house” meaning that the writers are full time employees of the pharma/biotech company or they can be consultants or out-sourced to a medical writing vendor.
A great resource to learn more about medical writing is American Medical Writers Association (AMWA)