Principal Medical Writer

Job Summary

Leading the development of high-quality regulatory and clinical documents, the full-time Principal Medical Writer will oversee medical writing workstreams, collaborate with cross-functional teams, and mentor junior writers in a remote setting.

Key responsibilities

• Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity
• Collaborate with clinical research, biostatistics, and regulatory affairs teams to gather and synthesize information for document development
• Provide guidance on best practices for medical writing and mentor junior medical writers to foster professional growth

Required qualifications

• A bachelor's degree in life sciences, pharmacy, or a related discipline
• Significant experience in medical writing, particularly in regulatory submissions and clinical documentation
• Strong understanding of regulatory requirements and industry standards for clinical writing
• Exceptional writing and editing skills, with a keen eye for detail and clarity
• Excellent communication and interpersonal skills for effective collaboration with diverse teams