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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Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
The Director, Medical Writing will be responsible for document development strategies and managing medical writing activities and timelines for clinical and regulatory/health authority drug marketing applications, including US (Investigational New Drug, New Drug Applications, Biologics Licensing Applications) and ex‑US (Clinical Trial Applications, Marketing Authorisation Applications) submissions. This position requires a highly motivated professional with experience in submitting successful drug marketing applications. Key success factors include exceptional leadership skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines; and the ability to supervise multiple medical writing projects, contractors, vendors, and budgets.
Position Responsibilities:
- Create, supervise, and direct complicated document submission plans and teams for marketing applications
- Collaborate with cross-functional partners to drive development, review, and finalization timelines for submission documents with a sense of urgency to meeting aggressive corporate goals
- Lead and manage senior-level subject matter experts in the development of complex summary documents (summary and integrated summary documents) for submissions
- Liaise with senior management to provide transparency on submission activities
- Manage internal and external resources (contractors, consultants, and vendors) to complete documents for drug applications and submissions
- Partner with Regulatory and Regulatory Operations to ensure successful submissions
- Represent Medical Writing on cross-functional teams and workstreams
- Develop templates, style guidelines, and SOPs related to the Medical Writing function
- Help build the Medical Writing group to adequately meet the document development needs of SRRK
Candidate Requirements:
- Advanced degree in a relevant scientific field preferred; Bachelor of Science in a relevant scientific field required
- 10+ years of experience in medical writing within the pharmaceutical/biotech industry, with at least 5+ years at a sponsor company; experience with devices is a plus
- 5+ years of experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA) health authorities
- Extremely strong leadership skills
- Expert knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
- Expert knowledge of requirements for the preparation of documents for drug marketing applications and for annual maintenance of clinical development programs (Investigator’s Brochures, Annual Reports, Clinical Study Reports)
- Ability to work independently in a fast-paced, small biotech corporate environment
- Ability to be creative and innovative
- Common sense
Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
The Director, Medical Writing will be responsible for document development strategies and managing medical writing activities and timelines for clinical and regulatory/health authority drug marketing applications, including US (Investigational New Drug, New Drug Applications, Biologics Licensing Applications) and ex‑US (Clinical Trial Applications, Marketing Authorisation Applications) submissions. This position requires a highly motivated professional with experience in submitting successful drug marketing applications. Key success factors include exceptional leadership skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines; and the ability to supervise multiple medical writing projects, contractors, vendors, and budgets.
Position Responsibilities:
- Create, supervise, and direct complicated document submission plans and teams for marketing applications
- Collaborate with cross-functional partners to drive development, review, and finalization timelines for submission documents with a sense of urgency to meeting aggressive corporate goals
- Lead and manage senior-level subject matter experts in the development of complex summary documents (summary and integrated summary documents) for submissions
- Liaise with senior management to provide transparency on submission activities
- Manage internal and external resources (contractors, consultants, and vendors) to complete documents for drug applications and submissions
- Partner with Regulatory and Regulatory Operations to ensure successful submissions
- Represent Medical Writing on cross-functional teams and workstreams
- Develop templates, style guidelines, and SOPs related to the Medical Writing function
- Help build the Medical Writing group to adequately meet the document development needs of SRRK
Candidate Requirements:
- Advanced degree in a relevant scientific field preferred; Bachelor of Science in a relevant scientific field required
- 10+ years of experience in medical writing within the pharmaceutical/biotech industry, with at least 5+ years at a sponsor company; experience with devices is a plus
- 5+ years of experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA) health authorities
- Extremely strong leadership skills
- Expert knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
- Expert knowledge of requirements for the preparation of documents for drug marketing applications and for annual maintenance of clinical development programs (Investigator’s Brochures, Annual Reports, Clinical Study Reports)
- Ability to work independently in a fast-paced, small biotech corporate environment
- Ability to be creative and innovative
- Common sense
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
- 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 Taylor Strategy Partners, Precision Medicine, and AstraZeneca, with the largest share of openings in Massachusetts, California, and New Jersey, based on current listings on Migrate Mate as of November 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 90% of associate director medical writing openings are fully remote or hybrid as of November 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.
See All 43 Associate Director Medical Writing Jobs
Find roles that match your experience and apply in just a few clicks.
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