Principal Medical Writer - FSP

Overview

We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.

The successful candidate will act as a lead writer for key summary documents , providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above) .

Key Responsibilities

• Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, ...