Senior Medical Writer (FSP)
Core
Primary author of routine clinical documents (study reports, protocols) and summaries of clinical study data, with potential support for complex regulatory submissions.
Role type
Senior Medical Writer (Clinical & Regulatory)
Builds
Clinical study reports, study protocols, clinical study summaries, and regulatory documents (IBs, INDs, MAAs)
Domain
Pharmaceutical/CRO industry, drug development, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
medical writing, data interpretation, regulatory documentation knowledge, drug development process knowledge, document management systems proficiency
Preferred skills
pharmaceutical/CRO industry experience, scientific writing experience
Technologies
document management systems, Excel, Outlook
Responsibilities
Write and provide input on routine clinical documents; summarize data from clinical studies; ensure compliance with quality processes; assist in program management activities; represent the department at project and review meetings
