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 QC review while ensuring compliance with regulatory guidelines.

Key responsibilities:

• Plan, write, edit, format, and perform QC review of clinical documents, ensuring alignment with regulatory requirements
• Oversee document management processes from initial template to final approved version in collaboration with internal and external teams
• Independently formulate key messages from clinical study data 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 in a sponsor and/or CRO setting or 7+ years as a Principal Medical Writer
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
• Clear understanding of ICH, FDA, GCP regulations, and eCTD requirements
• Impeccable attention to detail and ability to manage multiple high-priority projects effectively