Found Description
Sr Medical Writer
The role is located in Barcelona, Spain and involves leading the development and delivery of a broad range of medical documents. Responsibilities focus on ensuring scientific accuracy, regulatory compliance, and high‑quality content across multiple study phases.
Responsibilities
- Lead the clear and accurate completion of medical writing deliverables, coordinating activities across departments with minimal supervision.
- Develop documents including clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain‑language summaries, safety updates, clinical development plans, IND/NDA/eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
- Ensure compliance with regulatory standards (e.g., ICH E3) and company SOPs, client standards, and approved templates.
- Coordinate quality an...