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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Showing 5 of 34+ Director Medical Writing jobs
JOB TITLE: Senior Director, Medical Writing
LOCATION: Boston, MA
DATE PREPARED: September 15, 2026
JOB SUMMARY:
The Senior Director, Medical Writing is responsible for the development and execution of medical writing deliverables that support AVEO Oncology’s clinical development and regulatory writing portfolio. This individual is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation and provides strategic medical writing leadership across assigned clinical programs. The incumbent is responsible for the efficient preparation of high-quality, scientifically accurate, and strategically aligned medical writing deliverables that support clinical development, clinical safety, and regulatory requirements. The Senior Director will partner cross-functionally to ensure key scientific and strategic communication points are effectively conveyed and are consistent across program documentation.The incumbent will provide strategic oversight as well as hands-on support for critical medical writing deliverables and will contribute to the development and maintenance of medical writing best practices, processes, templates, and SOPs.
PRINCIPAL DUTIES:
- Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions
- Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders
- Is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation
- Applies knowledge of regulatory medical writing, clinical development, and oncology to support clinical programs across multiple stages of development
- Represents Medical Writing on cross-functional clinical development and regulatory teams and provides strategic guidance regarding document content, messaging, timelines, and regulatory requirements
- Ensures scientific data, key messages, terminology, and communication points are accurate and consistent across program documentation
- Interprets and synthesizes complex clinical, scientific, and statistical information into clear, concise, scientifically rigorous documents
- Leads medical writing activities supporting IND/CTA submissions and other global regulatory submissions and contributes to NDA/BLA/MAA submission activities, as applicable
- Partners with Regulatory Affairs and Clinical Development to anticipate future documentation requirements and ensure medical writing activities are aligned with program and submission timelines
- Leads or contributes to publication planning and execution, including abstracts, posters, oral presentations, manuscripts, and other scientific communications
- Collaborates with internal and external authors to develop publication content that appropriately communicates the scientific significance and clinical relevance of study results
- Understands the oncology publication landscape, including relevant journals, congresses, audiences, and publication practices, and advises internal teams and authors accordingly
- Ensures alignment of publication content with scientific communication objectives, program strategy, and approved terminology
- Manages outsourced medical writing projects and external vendors to ensure quality, strategic alignment, timely completion, and adherence to allocated budgets
- Reviews and provides strategic and editorial guidance on documents prepared by internal and external medical writers
- Drives timelines and advances multiple complex projects simultaneously while proactively identifying and mitigating potential risks to quality, content, resources, and timelines
- Ensures medical writing deliverables comply with applicable regulatory requirements, ICH guidelines, company standards, and industry best practices
- Serves as an internal resource to cross-functional teams regarding regulatory medical writing and compliant scientific communication practices
- Contributes to the establishment and maintenance of medical writing Best Practices, SOPs, templates, and document development processes
BASIC QUALIFICATIONS:
- Bachelor’s degree required; substantial coursework in life sciences or a related scientific discipline preferred
- Advanced scientific degree (PhD, PharmD, MD, MS or equivalent) preferred
- A minimum of 10 years of medical writing experience within the biopharmaceutical industry or a contract research organization, with significant experience in clinical and regulatory medical writing
- Demonstrated experience leading medical writing activities for clinical development programs and complex regulatory deliverables
- Experience preparing clinical study protocols, clinical study reports, Investigator’s Brochures, regulatory briefing documents, clinical summaries and other regulatory submission documents
- Experience supporting global regulatory submissions and health authority interactions preferred
- Oncology regulatory and clinical writing experience strongly preferred; experience supporting late-stage or registrational oncology programs is highly desirable
- Experience with publication development, including abstracts, posters, presentations, and peer-reviewed manuscripts
- Strong understanding of clinical drug development, regulatory requirements, ICH guidelines, CTD structure, and industry standards for clinical and regulatory documentation
- Excellent ability to analyze and interpret clinical, scientific, and statistical data and communicate complex information clearly and accurately
- Excellent ability in searching and interpreting medical literature
- Demonstrated ability to provide strategic leadership while remaining hands-on with complex and high-priority medical writing deliverables
- Strong interpersonal and communication skills, both oral and written, with demonstrated ability to work effectively within cross-functional teams
- Demonstrated ability to influence stakeholders, drive consensus, and manage document development in a matrixed environment
- Strong project management and organizational skills with the ability to manage multiple priorities and timelines simultaneously
- Experience managing external medical writing vendors and consultants
- Strong attention to detail and commitment to scientific accuracy, consistency, and quality
- Technical aptitude and proficiency with systems and technologies used to support document development, collaboration, virtual meetings, and regulatory submissions
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
JOB TITLE: Senior Director, Medical Writing
LOCATION: Boston, MA
DATE PREPARED: September 15, 2026
JOB SUMMARY:
The Senior Director, Medical Writing is responsible for the development and execution of medical writing deliverables that support AVEO Oncology’s clinical development and regulatory writing portfolio. This individual is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation and provides strategic medical writing leadership across assigned clinical programs. The incumbent is responsible for the efficient preparation of high-quality, scientifically accurate, and strategically aligned medical writing deliverables that support clinical development, clinical safety, and regulatory requirements. The Senior Director will partner cross-functionally to ensure key scientific and strategic communication points are effectively conveyed and are consistent across program documentation.The incumbent will provide strategic oversight as well as hands-on support for critical medical writing deliverables and will contribute to the development and maintenance of medical writing best practices, processes, templates, and SOPs.
PRINCIPAL DUTIES:
- Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions
- Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders
- Is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation
- Applies knowledge of regulatory medical writing, clinical development, and oncology to support clinical programs across multiple stages of development
- Represents Medical Writing on cross-functional clinical development and regulatory teams and provides strategic guidance regarding document content, messaging, timelines, and regulatory requirements
- Ensures scientific data, key messages, terminology, and communication points are accurate and consistent across program documentation
- Interprets and synthesizes complex clinical, scientific, and statistical information into clear, concise, scientifically rigorous documents
- Leads medical writing activities supporting IND/CTA submissions and other global regulatory submissions and contributes to NDA/BLA/MAA submission activities, as applicable
- Partners with Regulatory Affairs and Clinical Development to anticipate future documentation requirements and ensure medical writing activities are aligned with program and submission timelines
- Leads or contributes to publication planning and execution, including abstracts, posters, oral presentations, manuscripts, and other scientific communications
- Collaborates with internal and external authors to develop publication content that appropriately communicates the scientific significance and clinical relevance of study results
- Understands the oncology publication landscape, including relevant journals, congresses, audiences, and publication practices, and advises internal teams and authors accordingly
- Ensures alignment of publication content with scientific communication objectives, program strategy, and approved terminology
- Manages outsourced medical writing projects and external vendors to ensure quality, strategic alignment, timely completion, and adherence to allocated budgets
- Reviews and provides strategic and editorial guidance on documents prepared by internal and external medical writers
- Drives timelines and advances multiple complex projects simultaneously while proactively identifying and mitigating potential risks to quality, content, resources, and timelines
- Ensures medical writing deliverables comply with applicable regulatory requirements, ICH guidelines, company standards, and industry best practices
- Serves as an internal resource to cross-functional teams regarding regulatory medical writing and compliant scientific communication practices
- Contributes to the establishment and maintenance of medical writing Best Practices, SOPs, templates, and document development processes
BASIC QUALIFICATIONS:
- Bachelor’s degree required; substantial coursework in life sciences or a related scientific discipline preferred
- Advanced scientific degree (PhD, PharmD, MD, MS or equivalent) preferred
- A minimum of 10 years of medical writing experience within the biopharmaceutical industry or a contract research organization, with significant experience in clinical and regulatory medical writing
- Demonstrated experience leading medical writing activities for clinical development programs and complex regulatory deliverables
- Experience preparing clinical study protocols, clinical study reports, Investigator’s Brochures, regulatory briefing documents, clinical summaries and other regulatory submission documents
- Experience supporting global regulatory submissions and health authority interactions preferred
- Oncology regulatory and clinical writing experience strongly preferred; experience supporting late-stage or registrational oncology programs is highly desirable
- Experience with publication development, including abstracts, posters, presentations, and peer-reviewed manuscripts
- Strong understanding of clinical drug development, regulatory requirements, ICH guidelines, CTD structure, and industry standards for clinical and regulatory documentation
- Excellent ability to analyze and interpret clinical, scientific, and statistical data and communicate complex information clearly and accurately
- Excellent ability in searching and interpreting medical literature
- Demonstrated ability to provide strategic leadership while remaining hands-on with complex and high-priority medical writing deliverables
- Strong interpersonal and communication skills, both oral and written, with demonstrated ability to work effectively within cross-functional teams
- Demonstrated ability to influence stakeholders, drive consensus, and manage document development in a matrixed environment
- Strong project management and organizational skills with the ability to manage multiple priorities and timelines simultaneously
- Experience managing external medical writing vendors and consultants
- Strong attention to detail and commitment to scientific accuracy, consistency, and quality
- Technical aptitude and proficiency with systems and technologies used to support document development, collaboration, virtual meetings, and regulatory submissions
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Director Medical Writing Jobs by Experience Level
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Find Director Medical Writing JobsDirector Medical Writing Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Technology & Software
- Healthcare & Medical Services
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
Which companies are hiring the most director medical writings?
The companies hiring the most director medical writings right now include Veeva Systems, Alkermes, and Kyverna Therapeutics, with the largest share of openings in Massachusetts, California, and New York, based on current listings on Migrate Mate as of September 2026. Pharmaceutical companies and contract research organizations consistently account for the majority of director-level postings.
How many director medical writing jobs are remote?
About 96% of director medical writing openings are fully remote or hybrid as of September 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.
See All 34 Director Medical Writing Jobs
Find roles that match your experience and apply in just a few clicks.
Find Director Medical Writing Jobs