Job Description
Position Overview
The Senior Medical Writer (MW) will lead the development of high‑quality, on‑time clinical study documents, ensuring compliance with Precision MW Style Guide, SOPs, regulatory guidelines (ICH, FDA, GCP) and eCTD requirements.
Responsibilities
- 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 based on regulatory guidances
- Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
- Ability to independently formulate key messages from clinical study data
- Ability to author complex content using knowledge/skills and understanding of processes
- Ability...