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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Showing 5 of 34+ Associate 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.
Associate Director Medical Writing Jobs by Experience Level
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Find JobsAssociate Director 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 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
Which companies are hiring the most associate director medical writings?
The companies hiring the most associate 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. Contract research organizations and large biopharma companies tend to maintain the most consistent demand at this level.
How many associate director medical writing jobs are remote?
About 96% of associate director medical writing openings are fully remote or hybrid as of September 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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Find roles that match your experience and apply in just a few clicks.
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