Senior Medical Writer/Principal Medical Writer

Position Summary

The Senior Medical Writer/Principal Medical Writer will lead the development of high‑quality, on‑time clinical study documents. Responsibilities include clinical document planning, writing, editing/formatting, and QC review, ensuring compliance with Precision MW Style Guide, SOPs, applicable regulatory guidelines (ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents across all development phases and will execute MW activities with impeccable attention to detail.

Essential Functions

• Planning, writing, editing, formatting, and QC review of timely and high‑quality clinical documents including protocols, Investigational Brochures, ICF templates, DSURs, CSRs, CSR patient narratives, with clear understanding of regulatory content requirements.
• Ensure smooth and effective document management from template to final approved version in collaboratio...