Associate Director, Medical Writing

Job Summary

Leading the planning and delivery of complex clinical and regulatory documents, the full-time Associate Director, Medical Writing will provide strategic leadership in regulatory submissions while collaborating with cross-functional teams, with the potential for remote work.

Key responsibilities:

• Lead the development and authoring of regulatory documents such as clinical study reports and marketing application summaries
• Serve as the Regulatory Medical Writing lead on cross-functional program teams, ensuring high-quality documentation
• Provide strategic input into regulatory document planning and manage timelines for deliverables

Required qualifications:

• Bachelor's degree required; advanced degree in a scientific or regulatory field preferred
• 12+ years of medical writing experience in the pharmaceutical industry, with proven lead writer experience for key regulatory documents
• Strong understanding of the drug development lifecycle and regulatory submission processes
• Extensive knowledge of FDA, EMA, and ICH guidelines
• Demonstrated ability to lead cross-functional teams and manage complex document development projects