Senior Medical Writer

Job Summary

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