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Senior Director Medical Writing Jobs (NOW HIRING)

Genmab

Director, Medical Writing

Plainsboro, NJ

$198K - $297K/yr

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 ...

SAB

Director, Medical Writing

Sioux Falls, SD · Remote

$190K - $230K/yr

The Director, Medical Writing - Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting ...

Alnylam Pharmaceuticals

Director, Medical Writing

$196K - $265K/yr

Overview The Director, Medical Writing will provide Medical Writing leadership for drug development programs, collaborate with project teams on the strategy and development of clinical documents ...

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Senior Director Medical Writing information

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$39.5K

$142.9K

$279.5K

How much do senior director medical writing jobs pay per year?

As of Jun 14, 2026, the average yearly pay for senior director medical writing in the United States is $142,920.00, according to ZipRecruiter salary data. Most workers in this role earn between $101,500.00 and $161,000.00 per year, depending on experience, location, and employer.

What is the highest salary for a medical writer?

The highest salary for a senior medical writer can exceed $150,000 annually, especially for those with extensive experience, specialized knowledge, or leadership roles in pharmaceutical or biotech companies. Salaries vary based on location, industry, and level of expertise, with top earners often holding advanced certifications and managing complex projects.

What does a Senior Director of Medical Writing do?

A Senior Director of Medical Writing leads teams responsible for creating, reviewing, and managing scientific documents required for regulatory submissions, publications, and internal communications in the pharmaceutical or biotechnology industry. They oversee the development of clinical study reports, regulatory dossiers, and other scientific materials, ensuring accuracy, compliance, and clarity. Additionally, they collaborate closely with cross-functional teams, such as clinical, regulatory, and safety groups, to ensure that all documents meet industry standards and regulatory requirements. Their role also involves strategic planning, resource management, and mentoring junior writers.

What are some common challenges faced by Senior Directors of Medical Writing in managing cross-functional teams?

Senior Directors of Medical Writing often oversee teams that collaborate closely with clinical, regulatory, and scientific departments. One common challenge is aligning diverse stakeholder expectations and ensuring consistency in messaging across complex documents. Balancing tight regulatory timelines with high-quality deliverables, while mentoring and developing a team of writers, also requires strong organizational and communication skills. Successful directors foster open communication, set clear priorities, and adapt to shifting project requirements to keep teams productive and motivated.

What is the difference between Senior Director Medical Writing vs Medical Writer?

AspectSenior Director Medical WritingMedical Writer
CredentialsAdvanced degrees (MD, PhD, PharmD), extensive experienceBachelor's or Master's in life sciences, relevant writing experience
Work EnvironmentLeadership roles, strategic planning, cross-functional teamsHands-on writing, editing, and document preparation
Employer & Industry UsagePharmaceutical, biotech, regulatory agenciesPharmaceutical, biotech, medical communications
Search & Comparison IntentLeadership, strategic, senior rolesWriting, documentation, regulatory submissions

The Senior Director Medical Writing typically holds advanced degrees and extensive experience, focusing on strategic leadership and overseeing medical writing teams. In contrast, Medical Writers are primarily responsible for creating and editing scientific documents. The senior role involves higher-level management and strategic planning, while Medical Writers focus on producing accurate, compliant documentation.

How much do senior medical writers make in the US?

Senior medical writers in the US typically earn between $90,000 and $150,000 annually, depending on experience, location, and industry sector. They often possess strong scientific writing skills, familiarity with regulatory guidelines, and may hold advanced degrees or certifications.

What does a director of medical writing do?

A senior director of medical writing oversees the creation and review of scientific documents such as clinical study reports, regulatory submissions, and publication materials. They ensure that medical content complies with regulatory standards, is scientifically accurate, and aligns with project timelines, often managing teams of medical writers and collaborating with cross-functional teams.

Is there a demand for medical writers?

There is strong demand for medical writers, especially for senior roles like Senior Director Medical Writing, due to the need for clear, accurate scientific communication in the healthcare and pharmaceutical industries. The growth of clinical research, regulatory submissions, and medical education drives ongoing hiring in this field, with many companies seeking experienced professionals skilled in regulatory writing, medical editing, and compliance. Advanced degrees and familiarity with industry tools such as document management systems are often required.

What are the key skills and qualifications needed to thrive as a Senior Director Medical Writing, and why are they important?

To thrive as a Senior Director Medical Writing, you need deep expertise in scientific writing, regulatory requirements, and leadership, typically supported by an advanced degree in life sciences and extensive medical writing experience. Familiarity with document management systems, regulatory submission platforms, and guidelines such as ICH and FDA is essential. Exceptional communication, project management, and mentoring skills distinguish top performers in this role. These competencies are crucial for ensuring the accuracy, compliance, and strategic impact of medical documents within fast-paced pharmaceutical environments.
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Senior Director Medical Writing jobs near you
Director/Sr. Director, Medical Writing

Director/Sr. Director, Medical Writing

Liquidia Corporation

Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 3 days ago

Job description

Job Description
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry's top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
The Director/Senior Director, Medical Writing is responsible for providing strategic leadership and scientific expertise in the planning, development, authoring, review, and finalization of high-quality regulatory and clinical documents supporting drug development programs from early clinical development through registration and lifecycle management. This role serves as the lead medical writer for complex regulatory submissions and health authority interactions, ensuring documents are scientifically accurate, strategically aligned, compliant with global regulatory requirements, and delivered on schedule.
The Director/Senior Director partners closely with Clinical Development, Clinical Operations Regulatory Affairs, Biostatistics, Clinical Pharmacology, Pharmacovigilance, CMC, Quality and other cross-functional stakeholders to develop critical regulatory documents, including clinical protocols, clinical study reports (CSRs), briefing packages for regulatory agencies, Pediatric Study Plans (PSPs), Pediatric Investigation Plans (PIPs), and Common Technical Document (CTD) Module 2 summaries supporting INDs, NDAs, BLAs, MAAs, and lifecycle submissions.
Job Requirements
Education and Experience:
  • Bachelor's degree in life sciences, pharmacy, nursing, or related life sciences filed required.
  • Minimum 10 (Director) -12 years (Senior Director) of experience with significant focus in medical writing within biotechnology, pharmaceutical, CRO, or related environment.
  • Proven experience and knowledge in leading and executing medical writing strategy and execution in a fast paced bio-pharma landscape and/or demonstrated movement from large/medium pharma organizations to biotech.
  • Business travel 10-20% as required.
  • Senior Director: Experience managing medical writing teams and/or external vendors preferred.
Knowledge, Skills, and Abilities:
Technical Competencies
  • Strong understanding of drug development and combination product development.
  • Expert understanding of ICH guidelines, CTD structure, GCP requirements, and global regulatory expectations.
  • Strong expertise in preparing various nonclinical, clinical, and regulatory documents.
  • Familiarity with regulatory requirements across major health authorities (FDA, EMA, PMDA, MHRA, Health Canada, NMPA, ANVISA, etc).
  • Familiarity or experience working with VEEVA RIM, Starting Point templates, EndNote, and other technical tools to support document efficiency and quality.
Scientific and Analytical Skills
  • Ability to interpret and communicate complex clinical, statistical, pharmacological, and scientific information.
  • Strong data interpretation and synthesis skills.
  • Excellent critical thinking and problem-solving abilities.
  • Ability to identify data gaps and develop scientifically sound messaging strategies.
Leadership and Collaboration
  • Demonstrated ability to lead cross-functional teams in a matrix environment.
  • Strong stakeholder management and influence skills.
  • Ability to mentor junior staff and provide strategic guidance.
  • Compelling interpersonal verbal, written and presentation skills in communication with internal and external stakeholders.
  • Strong management and organizational skills with an ability to prioritize and accelerate multiple programs and projects.
  • High degree of independence, integrity, sound judgement and commitment to compliance.
Professional Competencies
  • Strong attention to detail and commitment to quality.
  • Ability to manage multiple complex projects simultaneously.
  • Demonstrated ability to work effectively under tight timelines and changing priorities.
  • High degree of professionalism, integrity, and accountability.
  • Commitment to continuous learning and process improvement.

Job Responsibilities
Medical Writing Leadership and Strategy:
  • Lead the medical writing strategy for assigned development programs across all stages of product development.
  • Serve as the primary medical writing representative on cross-functional project teams.
  • Develop document plans, timelines, and resource strategies to support regulatory milestones and corporate objectives.
  • Provide strategic input regarding document content, messaging, regulatory positioning, and submission readiness.
  • Ensure consistency of scientific messaging across regulatory submissions and health authority interactions.
  • Contribute to regulatory and development strategies through effective communication of clinical and scientific data.
Clinical Development and Regulatory Submission Documents:
  • Lead the planning, authoring, coordination, review, and finalization of various clinical development documents including, but not limited to:
    • Clinical study protocols and protocol amendments
    • Investigator brochures (IBs)
    • Clinical study reports (CSRs)
    • Clinical development plans
    • Statistical analysis plan summaries
    • Clinical overviews and summaries
    • Integrated summaries of safety (ISS)
    • Integrated summaries of efficacy (ISE)
    • Synopses and executive summaries
    • Ensure documents are scientifically accurate, data-driven, and compliant with applicable ICH, FDA, EMA, PMDA, NMPA, and other global requirements.
  • Partnering with the regulatory lead and applicable Subject Matter Experts, lead development of regulatory submission documents including, but not limited to:
    • INDs and IND amendments
    • CTAs and CTA amendments
    • Documents for NDAs, BLAs, MAAs and supplements
    • Briefing materials for health authority interactions
    • Nonclinical and Clinical Module 2 documents (2.4-2.7)
    • Orphan drug applications
    • Breakthrough Therapy, Fast Track, and other expedited pathway applications
    • Pediatric Study Plans, Pediatric Investigation Plans
    • Senior Director: Demonstrated experience leading major global submissions (not just individual documents within a major application).
Document Quality and Compliance:
  • Ensure all documents comply with ICH, GCP, CTD, and applicable regulatory guidance requirements.
  • Establish and maintain document standards, templates, style guides, and best practices.
  • Ensure quality control and consistency across documents and programs.
  • Support inspection readiness and document audit activities.
  • Maintain awareness of evolving regulatory expectations and industry standards.
Vendor and Resource Management (Sr Director):
  • Manage external medical writing vendors and consultants.
  • Oversee outsourced writing activities, quality, timelines, and budgets.
  • Review and approve vendor-generated deliverables.
  • Support vendor selection and performance management.
Leadership and Organizational Development (Sr Director):
  • When applicable, mentor and develop internal medical writers.
  • Contribute to departmental strategic planning and organizational growth.
  • Lead process improvement initiatives and implementation of best practices.
  • Participate in hiring, performance management, and talent development activities.
  • Serve as a subject matter expert for medical writing and regulatory document development across the organization.

Job Benefits
Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note :
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.

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