Medical Writing Associate Director

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.

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.

• 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.

The annual base salary for this position ranges from $175,000 - $190,000. In addition, this position is eligible for an annual performance pay bonus.  Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.  Additional details can be found on our careers website: www.alkermes.com/careers#working-here  

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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. 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.