Description
The Senior Medical Writer/Principal Medical Writer will lead the development of high-quality clinical study documents, including protocols, IBs, ICF templates, DSURs, CSRs, and patient narratives. The role covers document planning, writing, editing, formatting, quality-control review, document management, regulatory compliance, literature research, and process improvement. Candidates need a BS degree or equivalent in a scientific or medical discipline, relevant writing expertise, and either 5+ years of experience as a Senior Medical Writer in a sponsor or CRO setting or 7+ years as a Principal Medical Writer. The position also requires proficiency with Microsoft Office, Teams, Adobe Acrobat, and PowerPoint, along with knowledge of ICH, FDA, GCP, clinical-trial transparency, and eCTD requirements.
