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Medical Writing Associate Jobs (NOW HIRING)

IQVIA

Associate Director, Medical Writing

Durham, NC

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 ...

IQVIA

Associate Director, Medical Writing

Durham, NC

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 ...

Argenx

Associate Director, Medical Writing

$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 ...

Alkermes

Associate Director, Medical Writing

Waltham, MA · Hybrid

$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 ...

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 ...

Travere

Associate Director, Medical Writing

OR · On-site +1

The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD]), as well as other regulatory, clinical, and ...

Spyre Therapeutics

Associate Director, Medical Writing

OR · On-site +1

$170K - $199K/yr

As Associate Director, Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for medical writing strategy and ...

Spyre Therapeutics

Associate Director, Medical Writing

$170K - $199K/yr

As Associate Director, Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for medical writing strategy and ...

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Medical Writing Associate information

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$24K

$58.4K

$135K

How much do medical writing associate jobs pay per year?

As of Aug 15, 2026, the average yearly pay for medical writing associate in the United States is $58,439.00, according to ZipRecruiter salary data. Most workers in this role earn between $36,500.00 and $69,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical writing associate, and why are they important?

To thrive as a Medical Writing Associate, you need a solid background in life sciences or pharmacy, strong writing skills, and familiarity with medical terminology, often supported by a relevant degree. Proficiency in Microsoft Office, reference management software, and knowledge of regulatory submission systems are commonly required. Attention to detail, organization, and the ability to communicate complex information clearly are standout soft skills for this role. These abilities ensure accuracy, compliance, and effective communication of scientific data in regulatory and clinical documents.

What are some typical challenges faced by medical writing associates when working on regulatory submission documents?

Medical Writing Associates often encounter challenges such as managing tight deadlines, interpreting complex scientific data, and ensuring compliance with strict regulatory guidelines. Collaboration with cross-functional teams—including clinical researchers, statisticians, and regulatory affairs professionals—is essential to clarify data and maintain consistency throughout documents. Attention to detail and the ability to adapt to evolving industry standards are crucial for producing high-quality submissions that meet both regulatory requirements and client expectations.

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

AspectMedical Writing AssociateMedical Writer
Required CredentialsBachelor's degree in life sciences or related field; some roles may require certificationAdvanced degree (Master's or PhD) often preferred; strong writing and scientific background
Work EnvironmentPharmaceutical or biotech companies, CROs, or medical communication agenciesPharmaceutical companies, medical communication firms, or freelance
Employer & Industry UsageEntry to mid-level role supporting medical writing tasksSenior or specialized medical writing tasks, including regulatory documents

The Medical Writing Associate typically supports medical writing projects with a focus on assisting senior writers, while Medical Writers handle more complex, regulatory, or publication writing tasks. Both roles are essential in the medical communication industry, with the associate position often serving as a stepping stone to a full Medical Writer role.

What is a medical writing associate?

A Medical Writing Associate is a professional who creates, edits, and reviews scientific documents related to medicine, healthcare, and clinical research. They are often responsible for preparing regulatory documents, clinical study reports, manuscripts, and other materials that communicate complex medical information clearly and accurately. Medical Writing Associates work closely with researchers, clinicians, and regulatory teams to ensure that documents comply with industry standards and regulatory requirements. This role is essential in the pharmaceutical, biotechnology, and healthcare industries to support drug development and ensure clear communication of scientific data.
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Medical Writing Associate jobs near you
Infographic showing various Medical Writing Associate 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 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $58,439 per year, or $28.1 per hour.

Associate Director Medical Writing

Zentalis

San Diego, CA • Remote

Full-time

Re-posted 20 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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