Associate Director, Medical Writing

Alkermes • Waltham, MA

1d

About The Position

The Associate 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 Associate 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 Associate
Director applies advanced technical judgment to solve complex problems and
ensures Medical Writing activities are integrated with broader development and
regulatory objectives.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines
designed to help people living with complex and difficult-to-treat psychiatric
and neurological disorders. A global biopharmaceutical company, headquartered in
Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a
meaningful difference in the way people manage their diseases. We have a
portfolio of proprietary commercial products for the treatment of alcohol
dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national
organizations. In 2024 and 2025, we were certified as a Great Place to Work in
the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Responsibilities

• document development strategy
• planning
• execution
• leads clinical content development for complex submissions (including content strategy, organization, and resourcing)
• partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings
• resource planning
• matrix leadership

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed