Associate Director, Medical Writing

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