Position Summary

The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high‑quality and on‑time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.

Essential Functions

• Planning, writing, editing, formatting, and QC review of timely and high‑quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements base...