Director Medical Writing Jobs
Director Medical Writing jobs are open across pharmaceutical, biotechnology, medical device, and contract research organizations, from senior writer to executive director level, with specializations in regulatory submissions, clinical study reports, and publication strategy. Find a role that fits from the openings below and apply directly.
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INTRODUCTION
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.
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
- Degree Level: PhD
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 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.
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
- Degree Level: PhD
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 Director Medical Writing JobsDirector Medical Writing Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Alkermes2
- argenx2
- Calico Life Sciences1
- Denali Therapeutics1
- Exelixis1
Top Industries Hiring
- Biotechnology & Pharmaceuticals8
- Healthcare & Medical Services2
What Employers Look For
The qualifications that appear most often in director medical writing jobs.
- Advanced degree in life sciences, pharmacy, medicine, or a related field
- Seven or more years of regulatory medical writing experience in pharma or biotech
- Demonstrated experience leading NDA, BLA, or IND submission packages
- Proficiency in ICH guidelines, eCTD formatting, and regulatory submission standards
- Experience managing and developing a team of medical writers
- Strong background in clinical study reports and integrated clinical and statistical summaries
Tips for Your Director Medical Writing Job Search
Tailor your resume to regulatory depth
Hiring managers for director medical writing roles expect to see specific submission types you've led, such as NDAs, BLAs, or CTDs. List the therapeutic areas and regulatory agencies your documents were submitted to, not just job duties.
Showcase cross-functional leadership examples
Director-level roles require managing writers, medical reviewers, and clinical teams simultaneously. Your resume and cover letter should describe team size, the scope of deliverables you oversaw, and how you resolved timeline or scientific disputes.
Apply early to roles that fit
Migrate Mate lists 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 expertise
Oncology, rare disease, and CNS roles often require deep prior exposure in those areas. Prioritize listings where your therapeutic background aligns closely rather than applying broadly, since hiring committees value domain-specific regulatory writing history.
Prepare a writing sample portfolio in advance
Many director-level interviews include a portfolio review or writing exercise. Have redacted or publicly available examples of executive summaries, integrated summaries, or publication-ready manuscripts ready to share before your first screening call.
Negotiate scope before accepting an offer
Director medical writing roles vary widely in whether you're managing a team, an agency relationship, or both. Clarify reporting structure, headcount responsibility, and budget authority during final interviews so the offer reflects the actual role.
Director Medical Writing Jobs: Frequently Asked Questions
How many director medical writing jobs are remote?
About 50% of director medical writing openings are fully remote or hybrid as of June 2026, reflecting the documentation-heavy nature of the role. Regulatory strategy and publication planning positions tend to be the most remote-friendly sub-areas, while roles requiring close collaboration with clinical operations teams are more likely to require on-site presence.
How do you become a director medical writing?
You typically start with an advanced degree in a life sciences field and move into medical writing at a pharmaceutical company, biotech, or CRO. From there, you progress through senior writer and principal or lead writer roles, building expertise in regulatory submissions and cross-functional project leadership. Demonstrating that you can manage writers, own submission timelines, and communicate with medical and regulatory affairs teams is what moves you into director-level consideration.
Can you get a director medical writing job without direct regulatory experience?
It's uncommon but possible if you have deep clinical, scientific, or publication writing experience combined with demonstrated leadership. Some companies will consider candidates who've led large documentation or scientific communication projects outside of a traditional regulatory track, particularly if they hold an advanced clinical degree and can show they've managed complex, multi-stakeholder deliverables at scale.
What does the director medical writing interview process look like?
The process typically starts with a recruiter or HR screen, followed by a hiring manager interview focused on your regulatory submission history and leadership approach. Later rounds usually involve a panel with medical affairs, clinical development, or regulatory affairs stakeholders. Many companies include a written exercise or portfolio review. Final interviews often address how you've managed competing submission deadlines and mentored junior writers.
Where can I find and apply to director medical writing jobs?
You can find and apply to director medical writing jobs on Migrate Mate, which lists current openings from across the United States. Find roles that match your therapeutic area background, submission experience, and seniority level, then apply directly to each listing from the page.
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Jump back to the full list of openings and apply to any director medical writing role that fits.
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