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. Responsibilities include document planning, writing, editing, formatting, quality-control review, document management, key-message development, literature research, and contribution to medical-writing processes and templates. The role requires a scientific or medical degree, 5+ years of senior medical-writing experience in a sponsor or CRO setting or 7+ years as a Principal Medical Writer, proficiency with Microsoft and Adobe tools, and knowledge of ICH, FDA, GCP, clinical-trial transparency, and eCTD requirements. An advanced degree and oncology or rare-disease experience are preferred. The position is remote and requires the candidate to be legally authorized to work in the country of employment without employer sponsorship.
