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Director Medical Writing Jobs (NOW HIRING)

Genmab

Director, Medical Writing

Plainsboro, NJ

$198K - $297K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical ...

Meridabio

Director, Medical Writing

Cambridge, MA · On-site

$225 - $275/hr

The Director, Medical Writing will be responsible for authoring, reviewing, and managing a broad range of clinical and regulatory documents while helping establish and scale medical writing processes ...

Inctye

Director, Medical Writing

Job Summary (Primary function) The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical ...

Alkermes

Director, Medical Writing

Waltham, MA · On-site

$220K - $235K/yr

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 ...

Alkermes

Director, Medical Writing

Waltham, MA · Hybrid

$220K - $235K/yr

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 ...

Agomab

Senior Director, Medical Writing

Cambridge, MA · On-site

Senior Director, Medical Writing Department: Regulatory Affairs Employment Type: Permanent - Full Time Location: Agomab US Reporting To: Senior VP/Head of Regulatory Affairs Description This is a ...

IQVIA

Associate Director, Medical Writing

Durham, NC · On-site

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic ...

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How much do director medical writing jobs pay per year?

As of Aug 12, 2026, the average yearly pay for director medical writing in the United States is $232,369.00, according to ZipRecruiter salary data. Most workers in this role earn between $198,000.00 and $284,500.00 per year, depending on experience, location, and employer.

What is a director medical writing?

A Director of Medical Writing oversees the development of clinical and regulatory documents for pharmaceutical, biotech, or healthcare companies. They lead medical writing teams, ensuring high-quality, compliant, and scientifically accurate content for submissions, publications, and regulatory filings. This role involves collaborating with cross-functional teams, managing timelines, and maintaining adherence to industry guidelines. Strong leadership, project management, and writing expertise are essential for success in this position.

What are the responsibilities of a director of medical writing?

A director of medical writing works to write clinical documents, regulatory submission documents, manuals, research grant applications, and other technical medical publications. In this career, your duties include working to manage a team of writers and editors. You may also have author responsibilities yourself. Your employer may expect you to review documents written by other staff members and make or recommend changes. As the director of medical writing, you also create strategies for document writing and implement writing standards plans so that all employees know how to organize their documents to the same standard.

What are the typical daily responsibilities of a director medical writing?

A Director Medical Writing typically oversees a team of medical writers, ensuring the timely creation and quality of clinical and regulatory documents such as study protocols, clinical study reports, and submission dossiers. They collaborate closely with cross-functional teams including clinical operations, regulatory affairs, and biostatistics to align on project goals and timelines. In addition to managing and mentoring staff, they may also review and approve key documents, provide strategic input on document planning, and interact with clients or health authorities. This leadership role often involves balancing multiple projects simultaneously and problem-solving to navigate evolving industry requirements.

What are the key skills and qualifications needed to thrive in the director medical writing position, and why are they important?

To excel as a Director Medical Writing, you need advanced scientific expertise, strong leadership experience, and a background in life sciences or pharmacy, often supported by an advanced degree (PhD, PharmD, or MD). Familiarity with document management systems, regulatory submission platforms (such as eCTD), and certifications like the American Medical Writers Association (AMWA) are highly valued. Superior communication, strategic thinking, project management, and mentoring skills distinguish top performers in this position. These competencies ensure the production of high-quality documents, effective team leadership, and successful navigation of complex regulatory environments.

More about Director Medical Writing jobs
What cities are hiring for Director Medical Writing jobs? Cities with the most Director Medical Writing job openings:
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Director Medical Writing jobs near you
Infographic showing various Director Medical Writing job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $232,369 per year, or $111.7 per hour.

Director, Medical Writing

Merida Biosciences

Cambridge, MA • On-site

Full-time

Re-posted 20 days ago

Job description

Description:Director, Medical Writing


At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.


Merida Biosciences is seeking an experienced and strategic Director, Medical Writing to lead the development of high-quality clinical and regulatory documents that support our advancing pipeline. Reporting to the Senior Director, Regulatory Affairs & Medical Writing, this individual will serve as a key partner to Regulatory Affairs, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, Medical, Nonclinical, and CMC teams and ensure that scientifically robust messages are developed and communicated consistently in documents supported by Medical Writing.

The Director, Medical Writing will be responsible for authoring, reviewing, and managing a broad range of clinical and regulatory documents while helping establish and scale medical writing processes within a growing biotechnology organization. This role offers the opportunity to[EC1] lead the establishment and refinement of Medical Writing standards that align with Merida’s business needs while contributing to the advancement of innovative therapies for patients with serious diseases.


Key Responsibilities


Medical Writing Leadership

  • Serve as the medical writing lead across clinical development programs.
  • Establish and maintain medical writing standards, templates, processes, and document governance practices.
  • Develop timelines and manage document deliverables to support regulatory and clinical milestones.
  • Oversee external medical writing service providers and consultants as needed.
  • Contribute to departmental planning and operational excellence initiatives.

Regulatory and Clinical Documentation

  • Author, review, and coordinate preparation of:
    • Clinical study protocols and protocol amendments
    • Investigator's Brochures (IBs)
    • Clinical Study Reports (CSRs)
    • Regulatory meeting requests and briefing packages
    • Additional regulatory documents as assigned
    • Clinical summaries and overviews
    • Responses to regulatory authority questions
    • Oversee redactions of Medical Writing documents subject to public disclosure

Cross-Functional Collaboration

  • Partner closely with Regulatory Affairs to support global regulatory submission strategies and health authority interactions.
  • Collaborate with Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, Medical, Nonclinical, CMC, and Quality teams to develop high-quality documents.
  • Lead document planning and review meetings, ensuring alignment among stakeholders.
  • Review statistical analysis plans and draft statistical outputs
  • Ensure consistency of scientific messaging and data interpretation across all deliverables.

Quality and Compliance

  • Ensure documents comply with applicable regulatory requirements, ICH guidelines, GCP standards, and company policies.
  • Maintain high standards of scientific accuracy, quality, consistency, and clarity.
  • Drive efficient review and approval cycles to meet critical development timelines.
  • Support inspection readiness and audit activities as needed.
Requirements:

Qualifications

  • BA or BS in a relevant scientific or healthcare discipline; advanced degree preferred.
  • Minimum of 8 years of medical writing experience within biotechnology, pharmaceutical, or CRO settings, with at least 2 years in leadership role(s).
  • Demonstrated success authoring and leading development of clinical and regulatory documents supporting regulatory submissions.
  • Experience supporting global regulatory filings including IND and CTA deliverables.
  • Strong understanding of drug development, clinical research, and regulatory requirements.
  • Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is desirable.
  • Experience in a fast-paced biotechnology environment strongly preferred.

Knowledge and Skills

  • Exceptional scientific writing, editing, and communication skills.
  • Strong project management and organizational capabilities.
  • Ability to synthesize complex scientific and clinical information into clear and concise documents.
  • Experience managing multiple projects simultaneously in a deadline-driven environment.
  • Strong collaboration and influencing skills across functions and organizational levels.

Leadership Competencies

  • Strategic and critical thinker with strong execution capabilities.
  • Highly collaborative and team-oriented.
  • Demonstrates ownership, accountability, and sound judgment.
  • Thrives in a dynamic, entrepreneurial biotechnology environment.
  • Committed to excellence, continuous improvement, and patient-focused innovation.

Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Director level we target $225,000 to $275,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally.


Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.