Job Description
Job Summary
Medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents to ensure high‑quality completion of all assigned writing projects.
Job Responsibilities
- Compile, write, edit, and coordinate medical writing deliverables that present scientific information clearly and accurately.
- Complete a variety of documents including clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
- Adhere to regulatory standards such as ICH E3, company SOPs, client standards, approved templates, authorship requirements, and style guides while meeting deadlines and budget constraints.
- Coordinate quality and editorial reviews, manage source documentation, lead document reviews, and resolve client comments.
- Review statistical analysis plans and table/figure/listing specifications for appropr...