Senior Medical Writer

Leading the development of high-quality clinical study documents, the remote Senior Medical Writer will manage clinical document planning, writing, editing, and quality control review while ensuring compliance with regulatory guidelines. Key responsibilities Plan, write, edit, format, and perform QC review of clinical documents such as protocols and reports, ensuring compliance with regulatory guidelines Manage document workflows from creation to final approval in collaboration with internal and external teams Conduct literature-based research to support writing activities and contribute to the development of medical writing processes and templates Required qualifications BS degree or equivalent in a scientific or medical discipline with relevant writing expertise 5+ years of experience as a Senior Medical Writer or 7+ years as a Principal Medical Writer in a sponsor or CRO setting Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint Clear understanding of ICH, FDA, GCP regulations, and eCTD requirements for clinical development Impeccable attention to detail and ability to manage multiple high-priority projects effectively