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Director Medical Writing Jobs (NOW HIRING)

Alkermes

Associate Director, Medical Writing

Waltham, MA · On-site

$175K - $190K/yr

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 ...

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How much do director medical writing jobs pay per year?

As of Jul 22, 2026, the average yearly pay for director medical writing in the United States is $232,369.00, according to ZipRecruiter salary data. Most workers in this role earn between $198,000.00 and $284,500.00 per year, depending on experience, location, and employer.

What is a Director Medical Writing job?

A Director of Medical Writing oversees the development of clinical and regulatory documents for pharmaceutical, biotech, or healthcare companies. They lead medical writing teams, ensuring high-quality, compliant, and scientifically accurate content for submissions, publications, and regulatory filings. This role involves collaborating with cross-functional teams, managing timelines, and maintaining adherence to industry guidelines. Strong leadership, project management, and writing expertise are essential for success in this position.

What Are the Responsibilities of a Director of Medical Writing?

A director of medical writing works to write clinical documents, regulatory submission documents, manuals, research grant applications, and other technical medical publications. In this career, your duties include working to manage a team of writers and editors. You may also have author responsibilities yourself. Your employer may expect you to review documents written by other staff members and make or recommend changes. As the director of medical writing, you also create strategies for document writing and implement writing standards plans so that all employees know how to organize their documents to the same standard.

What are the typical daily responsibilities of a Director Medical Writing?

A Director Medical Writing typically oversees a team of medical writers, ensuring the timely creation and quality of clinical and regulatory documents such as study protocols, clinical study reports, and submission dossiers. They collaborate closely with cross-functional teams including clinical operations, regulatory affairs, and biostatistics to align on project goals and timelines. In addition to managing and mentoring staff, they may also review and approve key documents, provide strategic input on document planning, and interact with clients or health authorities. This leadership role often involves balancing multiple projects simultaneously and problem-solving to navigate evolving industry requirements.

What are the key skills and qualifications needed to thrive in the Director Medical Writing position, and why are they important?

To excel as a Director Medical Writing, you need advanced scientific expertise, strong leadership experience, and a background in life sciences or pharmacy, often supported by an advanced degree (PhD, PharmD, or MD). Familiarity with document management systems, regulatory submission platforms (such as eCTD), and certifications like the American Medical Writers Association (AMWA) are highly valued. Superior communication, strategic thinking, project management, and mentoring skills distinguish top performers in this position. These competencies ensure the production of high-quality documents, effective team leadership, and successful navigation of complex regulatory environments.

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Director Medical Writing jobs near you
Infographic showing various Director Medical Writing job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $232,369 per year, or $111.7 per hour.
Associate Director, Medical Writing

Associate Director, Medical Writing

Alkermes

Waltham, MA • On-site

$175K - $190K/yr

Full-time

Posted 8 days ago

Job description


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.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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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About Us
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.

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