Director of Medical Writing

Job Summary

Providing strategic leadership and hands-on execution, the full-time remote Director of Medical Writing will manage the development of high-quality clinical and regulatory documents, ensuring compliance and alignment with company priorities and regulatory standards.

Key responsibilities

• Lead the planning, authoring, review, and completion of clinical and regulatory documents for submissions to the FDA and global health authorities
• Manage internal and external medical writing resources to deliver accurate, high-quality documents on time
• Establish and continuously improve medical writing processes, templates, and best practices to enhance quality and operational efficiency

Required qualifications

• Bachelor's degree in life sciences or a related discipline; advanced degree preferred
• 10+ years of medical writing experience in the pharmaceutical or biotechnology industry
• Deep experience authoring and reviewing clinical and regulatory documents
• Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes
• Proficiency with Microsoft Office, Adobe Acrobat, and document management systems like SharePoint