Medical Writer
Core
Primary author of routine clinical study reports, study protocols, and data summaries, with potential support for complex regulatory documents like IBs, INDs, and MAAs.
Role type
Medical Writer (Clinical & Regulatory)
Builds
Clinical study reports, study protocols, regulatory submissions (IBs, INDs, MAAs)
Domain
Pharmaceutical/CRO industry, drug development
Required skills
medical writing, data interpretation, regulatory documentation knowledge, document management systems, project planning
Preferred skills
pharmaceutical/CRO industry experience, scientific writing
Technologies
document management systems, Excel, Outlook
Responsibilities
Write and provide input on clinical study reports and study protocols; summarize data from clinical studies; ensure compliance with quality processes; assist in program management activities like developing timelines and budgets; represent the department at project launch and review meetings.
