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Associate Director Medical Writing Jobs (NOW HIRING)

IQVIA

Associate Director, Medical Writing

Durham, NC · On-site

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 ...

Alkermes

Associate Director, Medical Writing

Waltham, MA · On-site

$175K - $190K/yr

The Associate Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on ...

IQVIA

Associate Director, Medical Writing

Durham, NC · On-site

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 ...

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 ...

Vrtx

Associate Director Medical Writing (Hybrid)

Boston, MA · Hybrid

$157K - $236K/yr

The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership ...

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 ...

Alkermes

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 ...

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 ...

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Associate Director Medical Writing information

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$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.
Associate Director Medical Writing

Associate Director Medical Writing

Zentalis

San Diego, CA • On-site

Full-time

Posted 6 days ago

Job description

ASSOCIATE DIRECTOR, MEDICAL WRITING


Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer andmultiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis isadvancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemotherapy, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.


POSITION SUMMARY:


The Associate Director, Medical Writing will provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions. This position will contribute to the medical and regulatory writing portfolio and will collaborate across functional groups within the company to lead and maintain standardized document development processes for clinical and regulatory documents. The Associate Director will report to the Head of Medical Writing.


ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Develop and execute strategies for organizing and preparing documents for clinical and regulatory health authority submissions.
  • Independently author and/or lead the authoring and end-to-end development of clinical and regulatory documents, including protocols and amendments, Investigator Brochure annual updates, CSRs, DSURs, eCTD modules for INDs and NDAs including clinical and nonclinical summaries and overviews, meeting requests, briefing books, and other documents required for oncology drug development.
  • Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, and briefing books.
  • Provide high-quality medical writing support to documents led by other company functional groups, including regulatory affairs, biostatistics, clinical operations, and clinical development.
  • Manage contract medical writers, as needed, including critically reviewing documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency, with adherence to timelines and team expectations.
  • Work on multiple concurrent deliverables.
  • Collaborate with relevant company subject matter experts and document owners to develop content that is well-organized, consistent, accurate, and appropriate for clinical and regulatory reviewers.
  • Collaborate with cross-functional teams, including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and biostatistics to ensure development of high-quality accurate documents delivered within project timelines.
  • Contribute towards the development of templates, SOPs, company style guide, and processes within medical writing to ensure quality and consistency of documents across programs.
  • Responsible for inspection-readiness of medical writing activities.
  • Collaborate with Regulatory Operations to support document formatting, publishing, and submission readiness.
  • Maintain up-to-date knowledge of global regulatory guidance and industry best practices.
  • Ensure final documents adhere to SOP, GCP, and ICH requirements


KEY QUALIFICATIONS AND EXPERIENCE:


  • Advanced degree in life sciences; PhD preferred.
  • At least 5-8 years of sponsor-level biotechnology or pharmaceutical clinical/regulatory medical writing experience required.
  • Extensive experience in oncology-focused medical writing, with significant exposure to regulatory submissions.
  • Recent direct or supportive NDA experience with clinical and regulatory documents, including authoring eCTD Module 2 clinical summaries (m2.7.2, m2.7.3, or m2.7.4) and/or overviews (m2.5), and Assessment Aid.
  • Significant experience with authoring protocols and amendments, Investigator Brochure annual updates, CSRs, and DSURs.
  • Must have strong analytical and critical thinking skills, strong attention to detail, ability to interpret and clearly present clinical data and other complex information, and an internal drive to produce clear and thorough, accurate, and high-quality documents.
  • Commitment to clearly understanding data and text, including proactively reaching out to medical writing senior management and/or subject matter experts to enable authoring clear and concise summary text that is understandable to reviewers from various backgrounds and experience.
  • Strong expertise in interpreting and synthesizing safety and efficacy data into meaningful insights and summaries.
  • Strategic thinker with a big-picture orientation.
  • Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines, and manage competing priorities.
  • Excellent written and verbal communication skills.
  • Exceptional partnership and collaboration skills. Able to prospectively identify potential problems and to partner effectively and positively to solve issues.
  • Understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
  • Knowledgeable in the regulatory guidance documents developed for documents authored by medical writing.
  • Ability to work independently, as well as collaboratively in a team.
  • Excellent time management skills and a proven ability to prioritize and work on multiple projects at any given time.
  • Working knowledge of AMA style, lean authoring, and regulatory document formatting conventions.
  • Expert in MS Office/Microsoft 365.
  • Experience with Veeva Vault preferred.

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