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Director Medical Writer Jobs (NOW HIRING)

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 ...

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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 ...

... a medical writer in the sponsor/CRO setting. Sponsor experience strongly preferred. * Experience ... writing direct reports * In-depth knowledge of Good Clinical Practices, FDA regulations, ICH ...

The Director, Medical Writing - Biologics will provide strategic and operational leadership for the ... Manage medical writer(s) who may be hired as SAB moves closer to BLA filing. * Collaborate closely ...

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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 ...

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 ...

The Medical Writer, Global Medical Affairs, reports to the Director of Medical Writing and is a key member of the scientific team. This role is responsible for developing clear, accurate, and ...

Medical Writer

Salt Lake City, UT · On-site

$95K - $124K/yr

Description The Medical Writer, Global Medical Affairs, reports to the Director of Medical Writing and is a key member of the scientific team. This role is responsible for developing clear, accurate ...

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Director Medical Writer information

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How much do director medical writer jobs pay per hour?

As of Jul 2, 2026, the average hourly pay for director medical writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

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

To thrive as a Director Medical Writer, you need advanced expertise in medical writing, a deep understanding of clinical research, and usually a graduate degree in life sciences or a related field. Familiarity with regulatory submission standards, document management systems, and tools like EndNote or electronic common technical document (eCTD) software is typically required. Exceptional leadership, project management, and communication skills distinguish top performers in this position. These competencies are crucial for ensuring the production of accurate, compliant documents that meet tight deadlines and regulatory expectations.

What are the main challenges a Director Medical Writer faces when managing multiple writing projects across different therapeutic areas?

A Director Medical Writer often oversees a diverse portfolio of projects, each with its own timelines, regulatory requirements, and subject matter experts. Balancing these responsibilities requires strong project management skills, as well as the ability to quickly adapt to new therapeutic areas and evolving client expectations. Clear communication and collaboration with cross-functional teams, including regulatory affairs, clinical operations, and external stakeholders, are essential to ensure accuracy and compliance. Staying current with industry standards and mentoring junior writers can also present additional challenges, but these efforts contribute to overall team success and professional growth.

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

AspectDirector Medical WriterMedical Writer
CredentialsTypically requires advanced degrees (MD, PhD, PharmD) and extensive experienceUsually holds a Bachelor's, Master's, or PhD in life sciences or related fields
Work EnvironmentLeads teams, manages projects, and interacts with senior stakeholdersFocuses on writing and editing scientific documents under supervision
Industry UsageUsed in pharmaceutical, biotech, and healthcare companies for strategic document oversightCommonly employed in similar industries for document creation and review

The main difference between a Director Medical Writer and a Medical Writer lies in their level of responsibility and experience. Directors oversee teams, manage projects, and contribute to strategic decisions, while Medical Writers primarily focus on producing and editing scientific documents. Both roles require strong scientific credentials, but the Director position demands more leadership and management skills.

What does a Director Medical Writer do?

A Director Medical Writer leads a team of medical writers responsible for creating scientific documents such as clinical study reports, regulatory submissions, and publications. They oversee the quality and accuracy of all written materials, ensuring compliance with regulatory standards and guidelines. Additionally, they collaborate with cross-functional teams, provide strategic guidance, and mentor junior writers within the organization. Their role is critical in translating complex clinical data into clear, concise content for regulatory agencies and healthcare professionals.
What cities are hiring for Director Medical Writer jobs? Cities with the most Director Medical Writer job openings:
What are the most commonly searched types of Medical Writer jobs? The most popular types of Medical Writer jobs are:
What states have the most Director Medical Writer jobs? States with the most job openings for Director Medical Writer jobs include:
Infographic showing various Director Medical Writer job openings in the United States as of June 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 61% Physical, 2% Hybrid, and 37% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.
Associate Director, Medical Writer

Associate Director, Medical Writer

Celldex Therapeutics

New Haven, CT • On-site

$153K - $199K/yr

Other

Medical, Retirement, PTO

Posted 10 days ago


Job description

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive-focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Overview
The Associate Director Medical Writing supports Celldex's clinical development programs through strategic and efficient management of medical writing projects, medical writing vendors, generation of documents relevant to clinical research, and meeting overall portfolio goals.
Responsibilities
  • Will lead teams in the timely delivery of high quality clinical research documents across all phases of clinical drug development. This includes but is not limited to: protocols, clinical study reports, Investigator's Brochures, and clinical summary modules.
  • Uses strong knowledge of regulatory guidance to instruct the project team accordingly to prepare a high-quality, regulatory compliant document.
  • Involved in MW process and tool development and training of colleagues
  • Assumes a lead role in creation, execution and monitoring of complex documents, project plans, management of timelines, and coordination of review meetings. Plans and coordinates timely review, revision and approval of clinical documents
  • Involved in developing style guidelines, department SOPs, and document templates.
  • Remains abreast of new regulatory guidance, industry trends, and technology and shares with the department and cross-functionally.
  • Leads process improvements related to creation and maintenance of clinical documentation and document management.
  • Assist other departments with writing projects on an ad-hoc basis.
  • Must be able to work on-site, attend business meetings, or travel between Celldex locations for business as required.

Qualifications
  • Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred.
  • Later phase writing experience (e.g., Phase 3) and BLA/NDA experience are strongly preferred.
  • Must have 5 or more years of experience as a medical writer preparing clinical regulatory submission documents.
  • 3+ years' experience in leading, developing and managing a team or equivalent vendor oversight.
  • Experienced in medical writing project leadership roles for complex submissions, preferably within the field of immunology.
  • Demonstrated ability to meet project goals within a matrix environment.
  • Lead document writing and related work for clinical development projects.
  • Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
  • Strong document management skills, including proficiency with MS Word, EndNote, and Excel.

Compensation
The expected base salary range for this position is $153,616 to $199,501
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach