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Director Medical Writing Jobs (NOW HIRING)

Vaxcyte

Director, Clinical Medical Writing

San Carlos, CA · On-site +1

$221K - $258K/yr

Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance. This position will lead ...

Stryker

Manager, Medical Writing

Portland, OR · Remote

$164K - $273K/yr

As the Manager, Medical Writing you will support clinical evaluation and regulatory documentation ... Direct development of clinical study protocols, clinical study reports, manuscripts, and scientific ...

Stryker

Manager, Medical Writing

Portland, OR · On-site

$164K - $273K/yr

As the Manager, Medical Writing you willsupport clinical evaluation and regulatory documentation ... Direct development of clinical study protocols, clinical study reports, manuscripts, and scientific ...

Biogen

Head of Medical Writing, West Coast Hub

$234K - $322K/yr

As the Head of Medical Writing, West Coast Hub (WCH), you will helm the functional oversight of ... while providing direct document-level support and mentoring for complex or high-priority ...

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How much do director medical writing jobs pay per year?

As of Jul 2, 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 job?

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.

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Director Medical Writing jobs near you
Infographic showing various Director Medical Writing job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 5% As Needed, 49% Full Time, 8% Part Time, and 37% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution, with an average salary of $232,369 per year, or $111.7 per hour.
Sr. Manager, Medical Writing

Sr. Manager, Medical Writing

Artiva Biotherapeutics, Inc.

San Diego, CA

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 3 days ago

Job description

About Artiva:

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate,AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.


For more information, visitwww.artivabio.com.


Job Summary:

The Sr. Manager, Medical Writing plays a key role in supporting clinical development, regulatory submissions, and scientific communications across Artiva Biotherapeutics. Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ideal candidate brings practical experience leading and preparing clinical and regulatory documents, a working knowledge of ICH/GCP and global regulatory expectations, and the ability to deliver clear, scientifically rigorous documents on tight timelines. This role has no direct reports and helps ensure that medical writing deliverables meet the highest scientific, editorial, and compliance standards through cross-functional collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance.

DUTIES/RESPONSIBILITIES:

  • Author clinical and regulatory documents, including clinical study protocols and amendments, Investigator Brochures, lab manuals, annual reports (e.g., DSURs/IND annual reports), clinical study reports, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, and BLAs/MAAs as applicable).
  • Write, edit, and collaborate with members of the clinical development team on a variety of clinical and regulatory documents, ensuring scientific accuracy, internal consistency, and compliance with established standards.
  • Support efficient document management and apply a consistent style of presentation to maintain quality and ease of review across documents assembled in a regulatory dossier.
  • Apply established standards and best practices for the document review, completion, and approval process; ensure adherence to regulatory requirements and guidelines, where applicable.
  • Collaborate with the team to develop and maintain medical writing standards, including document templates and style guides.
  • Review and edit documents or sections of documents prepared by functional area representatives and ensure adherence to established standards.
  • Author and coordinate high-quality written responses to health authority questions and deficiency letters in collaboration with Regulatory Affairs and other cross-functional partners.
  • Plan, write, edit, and review materials in collaboration with project teams, including conference abstracts, posters, oral presentations, and manuscripts, ensuring alignment with scientific strategies and corporate goals.
  • Coordinate and prioritize multiple project deadlines in a fast-paced environment; create and maintain timelines for assigned projects.
  • Perform quality review of documents in compliance with established standards and best practices and contribute to the overall quality of the medical writing program.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Bachelor's degree required; advanced degree (MS, PhD, PharmD, or equivalent) preferred in Biology, Chemistry, Biochemistry, or a related life science discipline.
  • Four or more years' experience preparing clinical and regulatory documents in a life science organization, including late-stage development experience (e.g., CSRs, BLA/MAA clinical sections).
  • Experience supporting cell therapy, gene therapy, or biologics programs is strongly preferred.
  • Demonstrated ability to author and edit clinical-regulatory documents (e.g., protocols, IBs, CSRs, ICFs, briefing documents, and clinical sections of CTAs/INDs/IMPDs) with minimal supervision.
  • Working knowledge of ICH/GCP guidelines, FDA and EMA expectations for clinical-regulatory documents, and applicable editorial standards.
  • Experience supporting health authority interactions, including preparation of briefing documents and written responses to agency questions, is preferred.
  • Strong analytical, written, and editorial skills; ability to communicate complex scientific concepts clearly and concisely.
  • Strong organizational skills and attention to detail; ability to manage multiple projects and competing deadlines in a fast-paced, dynamic environment.
  • Ability to work effectively with internal and outsourced teams and to develop productive working relationships with key cross-functional stakeholders, including Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance.


In addition to a great culture, we offer:

  • A beautiful facility
  • An entrepreneurial, highly collaborative, and innovative environment
  • Comprehensive benefits, including:
  • Medical, Dental, and Vision
  • Group Life Insurance
  • Long Term Disability (LTD)
  • 401(k) Retirement Plan
  • Employee Assistance Program (EAP)
  • Flexible Spending Account (FSA)
  • Paid Time Off (PTO)
  • Company paid holidays, including the year-end holiday week
  • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.


If all this speaks to you, come join us on our journey!


Base Salary: $165,000 - 180,000. Exact compensation may vary based on skills and experience.

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