Principal Medical Writer

Job Summary

Representing medical writing on multi-disciplinary teams, the full-time Principal Medical Writer will oversee the development of clinical documents, manage contract writers, and ensure compliance with regulations while working remotely.

Key responsibilities:

• Produce high-quality clinical documents, including protocols and study reports, on time
• Lead supplemental filings and provide medical writing expertise to project teams
• Facilitate the review and finalization process for documents produced by internal and external writers

Required qualifications:

• Bachelor's degree in Life Science or English/Communications; advanced degree preferred
• 7+ years of medical writing experience in a sponsor/CRO setting, with regulatory submission experience strongly preferred
• In-depth knowledge of Good Clinical Practices, FDA regulations, and ICH guidelines
• Experience managing multiple projects in a fast-paced environment
• Proficiency in Microsoft Windows, Word, Excel, and PowerPoint