Director of Medical Writing

Job Summary

To support the development of precision medicines, the full-time remote Director of Medical Writing will serve as a subject matter expert on clinical regulatory documents and collaborate with cross-functional teams to ensure timely and high-quality document delivery.

Key responsibilities

• Prepare and oversee clinical regulatory documents through all phases of clinical research
• Represent medical writing in cross-functional team meetings and collaborate with various departments to ensure document quality
• Manage external vendors and improve operational processes related to medical writing documentation

Required qualifications

• Bachelor's, Master's, or PhD in a scientific, medical, or clinical discipline; advanced degrees preferred
• 10-12 years of relevant industry experience in medical writing, preferably in oncology
• Experience in authoring clinical study reports, protocols, and regulatory submissions
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
• Proficiency in MS Word and familiarity with document formatting tools and EDMS systems