Associate Director Medical Writing Jobs
Associate Director Medical Writing jobs are open across pharmaceutical, biotechnology, contract research organizations, and medical device companies, from senior writer to executive director level, with specializations in regulatory submissions, clinical study reports, and scientific communications. Find a role that fits from the openings below and apply directly.
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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.
BASIC QUALIFICATIONS
- Doctorate Degree
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.
INTRODUCTION
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.
BASIC QUALIFICATIONS
- Doctorate Degree
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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Find JobsAssociate Director Medical Writing Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- argenx2
- Alkermes1
- Calico Life Sciences1
- Exelixis1
Top Industries Hiring
- Biotechnology & Pharmaceuticals5
- Healthcare & Medical Services1
What Employers Look For
The qualifications that appear most often in associate director medical writing jobs.
- Advanced degree in life sciences, pharmacy, or a related scientific field
- Extensive experience authoring regulatory documents including CTDs, CSRs, and IBs
- Demonstrated experience managing or mentoring medical writers across projects
- Deep knowledge of ICH guidelines, FDA, and EMA submission requirements
- Strong cross-functional collaboration with clinical, regulatory, and biostatistics teams
- Experience with structured authoring tools and document management systems
Tips for Your Associate Director Medical Writing Job Search
Tailor your resume to submission types
Hiring managers at associate director level want to see which document types you own: CTDs, IND/NDA modules, CSRs, IBs. List them explicitly in a competencies section rather than burying them in job descriptions, so reviewers can match your experience to their pipeline.
Show leadership scope not just output
Associate director roles require demonstrated people leadership and cross-functional influence. Quantify team size you managed, writers you mentored, or review cycles you led. Employers distinguish candidates who wrote prolifically from those who led a writing function.
Apply early to roles that fit
Migrate Mate lists associate director medical writing openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Filter openings by therapeutic area first
Oncology, rare disease, and neuroscience teams often require depth in their TA, not just regulatory writing skill. Prioritize openings where your therapeutic background aligns, and name that alignment in your cover letter with specific molecule or indication experience.
Prepare a writing sample portfolio in advance
Many hiring panels for associate director candidates request a redacted regulatory document or a before-and-after editing sample. Have two or three de-identified examples ready before interviews start so you aren't scrambling to obtain approvals mid-process.
Negotiate scope alongside salary at offer stage
At associate director level, title scope varies widely: some roles own a single modality while others manage a full department. During offer negotiation, clarify direct reports, budget authority, and cross-functional decision rights so you enter the role with aligned expectations.
Associate Director Medical Writing Jobs: Frequently Asked Questions
How many associate director medical writing jobs are remote?
About 60% of associate director medical writing openings are fully remote or hybrid as of June 2026, reflecting how document-centric this role is. Regulatory writing and clinical submission work is most likely to remain remote, while roles requiring close oversight of on-site writing teams or involvement in early discovery tend to require more in-person presence.
How do you become an associate director medical writing?
You typically progress to associate director medical writing by first building several years of hands-on regulatory writing experience, mastering document types like CSRs, IBs, and CTD modules. From there, you take on team lead or principal writer responsibilities, demonstrate cross-functional project ownership, and develop people management skills by mentoring junior writers through full submission cycles.
Can you get an associate director medical writing role with limited experience?
Stepping directly into an associate director role with limited experience is uncommon because most employers expect candidates to have already led complex submissions and managed writers. A practical path is to move into a principal or lead medical writer position first, build a portfolio of end-to-end regulatory documents, and volunteer for mentoring or process improvement work that demonstrates readiness for director-level responsibility.
What does the associate director medical writing interview process look like?
The interview process for associate director medical writing typically involves an initial recruiter screen, a hiring manager conversation focused on your regulatory document expertise and leadership philosophy, and then a panel interview with cross-functional stakeholders from clinical operations, regulatory affairs, and biostatistics. Many companies also include a writing or editing exercise using a redacted or mock document, followed by a final discussion with senior leadership about strategic priorities.
Where can I find and apply to associate director medical writing jobs?
You can find and apply to associate director medical writing jobs on Migrate Mate, which lists current openings from across the United States. Find roles that match your therapeutic area background and regulatory expertise, then apply directly to each listing that fits.
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Jump back to the full list of openings and apply to any associate director medical writing role that fits.
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