Associate Director, Medical Writing

Responsibilities:
- Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing.
- Independently author and lead the planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents.
- Lead or coordinate clinical content development for complex regulatory submissions, ensuring messaging alignment with regulatory strategy and development objectives.
- Serve as the primary medical writing lead on program teams, proactively identifying risks, anticipating cross-functional challenges, and driving issue resolution.
- Oversee outsourced writing support, setting expectations, managing review cycles, and ensuring inspection-ready quality.
- Contribute to the development and execution of Medical Writing departmental goals, including process improvements, inspection readiness initiatives, and adoption of new tools and technologies.

Qualifications:
- Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline.
- 8+ years of relevant experience in medical writing, clinical research, or a related function; 2+ years of people-management or supervisory experience preferred.
- Experience supporting marketing authorization applications (NDA/BLA/MAA), IND submissions, and other major regulatory filings.
- Demonstrated ability to lead complex projects, plan and optimize resources (internal staff, vendors, and tools), and manage competing priorities.
- Strong ability to work independently, navigate ambiguity, and resolve complex, non-routine problems through pragmatic risk mitigation.
- Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred but not required.
- Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.