Director, Medical Writing

Alkermes

2d•Hybrid

About The Position

The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.

Requirements

Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline.
10+ years of relevant experience in medical writing, clinical research, or a related function
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.

Nice To Haves

2+ years of people-management or supervisory experience preferred.
neuroscience experience preferred but not required.

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.