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Director Medical Writer Jobs (NOW HIRING)

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 ...

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 ...

Summit Therapeutics

Director, Medical Writing

The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program ...

Sumitomopharma

QC Medical Writer

$100K - $126K/yr

This position reports to Executive Director, Medical Writing Oncology and is part of the Medical Writing Function. We are currently seeking a dynamic, highly motivated, and experienced individual for ...

Biogen, Inc.

$200 - $250/hr

As the Director of Medical Writing for the West Coast Hub (WCH) you are responsible for the writing and/or managing complex marketed and development programs at the portfolio level based on ...

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Director Medical Writer information

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How much do director medical writer jobs pay per hour?

As of Sep 7, 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 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 are the key skills and qualifications needed to thrive as a director medical writer?

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 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:

Director Medical Writer jobs near you
Infographic showing various Director Medical Writer 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 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.

Associate Director, Medical Writing

IQVIA, Inc.

Durham, NC • On-site

Full-time

Re-posted 22 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

63rd of 226 rated it services

Job description

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 partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency
This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions
  • This role reports to the Director of Medical Writing
  • Senior Medical Writer(s) and Medical Writer(s) will report to this role

Main Responsibilities and Accountabilities
  • Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities:
  • Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives
  • Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed.
  • Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission)
  • The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
  • Forecasting, budgeting, resource planning and resource allocation.
  • Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work

Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development
  • Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).

  • Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
  • Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
  • Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
  • Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
  • Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data
  • Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
  • Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.

  • Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
  • Responsible for continual improvement of in-house medical writing.
  • Provides expert medical writing support to other CR&D and CSL groups where required
  • In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
  • Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance.
  • Participant in bid defense, contract development, work alignment and / or operation meetings.
  • Post-graduate qualifications (PhD or MD preferred)

Experience
  • A minimum of 8 years medical writing experience within the biopharmaceutical
  • industry or a contract research organization.
  • A minimum of 3 years in a supervisory role
  • A comprehensive understanding of the clinical development process, including the
  • documents that are required at each stage.
  • A comprehensive understanding of medical writing processes, standards and issues.
  • Demonstrated track record in cross-functional, multicultural and international clinical trial teams
  • Excellent verbal, written and presentation skills.
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Prior experience with submissions in Common Technical Document (CTD) format.
  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US

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