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Associate Director Medical Writing Jobs (NOW HIRING)

Argenx

Director of Medical Writing

For the expansion of our team, argenx is looking for a Director of Medical Writing to manage medical writers and author content. This individual will also develop critical infrastructure for the ...

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 ...

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Associate Director Medical Writing information

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$75.5K

$164.8K

$262.5K

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

As of Jul 2, 2026, the average yearly pay for associate director medical writing in the United States is $164,797.00, according to ZipRecruiter salary data. Most workers in this role earn between $121,500.00 and $200,000.00 per year, depending on experience, location, and employer.

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

To thrive as an Associate Director Medical Writing, you need advanced knowledge of clinical research, regulatory requirements, and scientific writing, typically supported by a life sciences degree and extensive medical writing experience. Familiarity with document management systems, regulatory submission platforms, and guidelines such as ICH and FDA is crucial. Outstanding leadership, attention to detail, and strong communication skills help manage teams and ensure clarity in complex scientific documents. These competencies are vital for producing high-quality regulatory documents that meet industry standards and support successful drug development.

How does an Associate Director of Medical Writing typically collaborate with cross-functional teams during the drug development process?

As an Associate Director of Medical Writing, you will frequently collaborate with regulatory affairs, clinical development, biostatistics, and medical affairs teams to ensure the accuracy and compliance of regulatory documents. This role often involves leading writing teams, managing timelines, and synthesizing input from subject matter experts to produce high-quality submissions. Effective communication and project management skills are crucial, as you’ll coordinate review cycles, address feedback, and ensure consistency across documents. These cross-functional interactions are essential for meeting regulatory requirements and supporting successful drug submissions.

What does an Associate Director of Medical Writing do?

An Associate Director of Medical Writing leads a team of medical writers in creating and reviewing scientific documents for regulatory submissions, publications, and clinical studies. They ensure accuracy, compliance with guidelines, and high-quality content while managing timelines and collaborating with cross-functional teams such as clinical, regulatory, and biostatistics departments. This role often involves mentoring junior writers, overseeing project workflows, and providing strategic input on document development. Their work plays a critical role in the successful communication of clinical research findings and regulatory submissions.

What does a director of medical writing do?

A director of medical writing oversees the creation of scientific and regulatory documents for pharmaceutical, biotech, or healthcare companies. They manage teams of medical writers, ensure compliance with industry standards, and coordinate the development of materials such as clinical study reports, regulatory submissions, and publication content.

What is the highest salary for a medical writer?

The highest salary for a medical writer, including associate directors in medical writing, can exceed $150,000 annually, especially with extensive experience, advanced degrees, and expertise in regulatory writing or clinical documentation. Senior roles in pharmaceutical or biotech companies tend to offer higher compensation, often supplemented with bonuses and benefits.

Is there a demand for medical writers?

The demand for medical writers, including Associate Director Medical Writers, is strong due to the need for clear scientific communication in pharmaceuticals, biotech, and healthcare industries. Skilled medical writers with knowledge of regulatory requirements and proficiency in tools like Microsoft Word and reference management software are sought after, especially as the industry continues to grow and evolve.

How much does an associate medical writer make in the US?

An associate medical writer in the US typically earns between $60,000 and $80,000 annually, depending on experience, education, and location. Entry-level positions may start lower, while experienced writers with specialized skills can earn higher salaries, often with opportunities for professional development and certification.

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

AspectAssociate Director Medical WritingMedical Writer
QualificationsAdvanced degree (MD, PhD, PharmD), extensive experience in medical writingBachelor's or Master's degree in life sciences or related field
Work EnvironmentLeads teams, manages projects, collaborates with cross-functional teamsPrepares clinical and regulatory documents, works under supervision
ResponsibilitiesStrategic oversight, team management, high-level reviewDrafts and edits clinical/regulatory documents, supports project teams

The Associate Director Medical Writing typically holds advanced degrees and has leadership responsibilities, overseeing teams and strategic projects. Medical Writers usually have relevant scientific degrees and focus on producing high-quality documents under supervision. The roles differ mainly in scope, responsibility, and level of experience required.

More about Associate Director Medical Writing jobs
What cities are hiring for Associate Director Medical Writing jobs? Cities with the most Associate Director Medical Writing job openings:
What states have the most Associate Director Medical Writing jobs? States with the most job openings for Associate Director Medical Writing jobs include:
What job categories do people searching Associate Director Medical Writing jobs look for? The top searched job categories for Associate Director Medical Writing jobs are:
Associate Director Medical Writing jobs near you
Infographic showing various Associate Director Medical Writing job openings in the United States as of June 2026, with employment types broken down into 89% Full Time, and 11% Part Time. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution, with an average salary of $164,797 per year, or $79.2 per hour.
Director/Sr. Director, Medical Writing

Director/Sr. Director, Medical Writing

Liquidia Corporation

Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 21 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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