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...