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Associate Director Medical Writing Jobs (NOW HIRING)

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 ...

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 ...

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 ...

The Associate Director, Medical Writing is responsible for contributing to the medical writing portfolio within the clinical and regulatory areas. This includes authoring briefing documents, clinical ...

Associate Director, Medical Writing

OR · Remote

$164K - $225K/yr

For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory ...

For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory ...

Director, Medical Writing

Princeton, NJ · On-site +1

$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 ...

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 ...

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 ...

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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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 Jun 9, 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 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:
Associate Director, Medical Writing

Associate Director, Medical Writing

Alkermes

Waltham, MA • Hybrid

$175K - $190K/yr

Full-time

Posted 24 days ago


Job description

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 writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Associate Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.

  • Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline.

  • 8+ years of relevant experience in medical writing, clinical research, or a related function; 2+ years of people-management or supervisory experience preferred.

  • Experience supporting marketing authorization applications (NDA/BLA/MAA), IND submissions, and other major regulatory filings.
  • Demonstrated ability to lead complex projects, plan and optimize resources (internal staff, vendors, and tools), and manage competing priorities.
  • Strong ability to work independently, navigate ambiguity, and resolve complex, non-routine problems through pragmatic risk mitigation.

  • Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred but not required.
  • Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. 

The annual base salary for this position ranges from $175,000 - $190,000. In addition, this position is eligible for an annual performance pay bonus.  Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.  Additional details can be found on our careers website: www.alkermes.com/careers#working-here  

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  • Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing.

  • Independently author and lead the planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents.

  • Lead or coordinate clinical content development for complex regulatory submissions, ensuring messaging alignment with regulatory strategy and development objectives.

  • Serve as the primary medical writing lead on program teams, proactively identifying risks, anticipating cross-functional challenges, and driving issue resolution.

  • Oversee outsourced writing support, setting expectations, managing review cycles, and ensuring inspection-ready quality.

  • Contribute to the development and execution of Medical Writing departmental goals, including process improvements, inspection readiness initiatives, and adoption of new tools and technologies.