Associate Director of Medical Writing

Job Summary

Providing leadership and functional oversight, the full-time Associate Director of Medical Writing will independently plan, manage, and develop content for clinical and regulatory documents in a remote setting, ensuring compliance with company guidelines to support regulatory filings.

Key responsibilities

• Independently plan and author complex clinical documents, including protocols and study reports, to meet regulatory requirements
• Provide strategic input and guidance to matrixed teams on document scope, content, and timelines
• Review and oversee documents prepared by external contractors for accuracy and alignment with company standards

Required qualifications

• Bachelor's degree in physical or life sciences with 8+ years of experience, or Master's degree with 6+ years in medical writing and project management
• PhD is highly desirable with a minimum of 5+ years of relevant experience in the pharmaceutical industry or CROs
• Demonstrated experience in clinical regulatory writing in a pharmaceutical or biotech environment
• Strong understanding of Microsoft Office and experience with Veeva Vault document management
• Familiarity with ICH E6 and E3 regulatory guidance