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Regulatory Medical Writer Jobs (NOW HIRING)

Sobi

Principal Medical Writer

San Diego, CA · Hybrid

A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes * Experience in ...

Sobi

Principal Medical Writer

San Diego, CA · Hybrid

A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes * Experience in ...

Sobi

Principal Medical Writer

San Diego, CA · On-site

A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes * Experience in ...

Syneoshealth

OR · On-site

$95K - $210K/yr

Sr. Principal Regulatory Medical Writer - Oncology Preferred Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with ...

Medasource

Lead Medical Writer

Dublin, OH · On-site

$80 - $90/hr

As a Lead Medical Writer on a 2-month remote contract, you will autonomously author and review a range of clinical regulatory documents, including CTD Module II summaries, Clinical Overviews ...

Ipsen

Senior Medical Writer

Cambridge, MA

In this role, the writer will develop regulatory documents for submission to global health authorities across clinical and safety domains. Working with minimal oversight, the Senior Medical Writer ...

Telix Pharmaceuticals (AMER)

OR

This role will provide medical writing support by organizing, analyzing, and interpreting ... Such documents include all types of regulatory documents, including eCTD summary documents (for ...

Collate

Medical Writer

San Francisco, CA

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

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Regulatory Medical Writer information

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How much do regulatory medical writer jobs pay per hour?

As of Jul 18, 2026, the average hourly pay for regulatory 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.

Is there a demand for medical writers?

Regulatory medical writers are in high demand due to the growing need for clear, compliant documentation in the pharmaceutical, biotech, and healthcare industries. They often require knowledge of regulatory guidelines and proficiency with tools like document management systems, with employment opportunities increasing as companies prioritize regulatory submissions and clinical documentation.

How much does a regulatory medical writer make?

A regulatory medical writer's salary typically ranges from $70,000 to $130,000 annually, depending on experience, education, and location. Senior writers with specialized skills or certifications can earn higher salaries, especially in the pharmaceutical or biotech industries where regulatory documentation is critical.

How to get into regulatory medical writing?

To become a regulatory medical writer, gaining a background in life sciences or healthcare is essential, often complemented by experience in clinical research or medical communications. Developing strong writing skills, understanding regulatory guidelines such as ICH and FDA requirements, and obtaining certifications like the Regulatory Affairs Certification (RAC) can improve job prospects. Entry typically involves building a portfolio of writing samples and applying for roles in pharmaceutical, biotech, or medical device companies.

What are the key skills and qualifications needed to thrive in the Regulatory Medical Writer position, and why are they important?

To thrive as a Regulatory Medical Writer, you need strong scientific knowledge, excellent written communication skills, and a degree in life sciences or a related field. Proficiency with regulatory documentation formats (such as CTD/eCTD), familiarity with guidelines like ICH, and experience using document management systems are often required. Meticulous attention to detail, organizational skills, and the ability to collaborate effectively with cross-functional teams are valuable soft skills. These qualifications are crucial to ensure the accurate, compliant, and timely preparation of regulatory submissions supporting drug approvals and clinical research.

What is a medical regulatory writer?

A medical regulatory writer is a professional who prepares and reviews scientific and regulatory documents required for drug, device, or biologic approvals. They ensure compliance with industry standards and regulatory agency guidelines, often working with clinical trial data, safety reports, and submission dossiers. Strong writing skills, knowledge of regulations such as FDA or EMA requirements, and attention to detail are essential in this role.

What are some typical challenges faced by Regulatory Medical Writers in their daily work?

Regulatory Medical Writers often face tight deadlines and shifting project priorities, especially when coordinating documents needed for regulatory submissions. They must interpret complex scientific data and adhere strictly to changing regulatory guidelines, which can be demanding. Navigating feedback from multiple stakeholders—such as clinical, regulatory, and statistical teams—requires strong communication and negotiation skills. Staying organized and proactively managing timelines are essential for success in this fast-paced, detail-oriented role.

What is a Regulatory Medical Writer job?

A Regulatory Medical Writer prepares clinical and regulatory documents required for drug development and approval processes. They collaborate with scientists, clinicians, and regulatory teams to create clear, accurate, and compliant documents such as clinical study reports, investigator brochures, and regulatory submissions. Their work ensures that complex scientific data is communicated effectively to regulatory agencies like the FDA or EMA. Strong writing, analytical, and compliance knowledge are essential for this role.

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Regulatory Medical Writer jobs near you
Infographic showing various Regulatory Medical Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.
Senior Regulatory Medical Writer - Fractional (Remote)

Senior Regulatory Medical Writer - Fractional (Remote)

Penfield Search Partners

Fairfield, CT • Remote

Other

Re-posted 2 days ago

Job description

Job Description Contact: Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities. This role focuses on independently updating and finalizing regulatory documents to support ongoing agency interactions and submission deliverables, working alongside internal and contract writers. Scope of Work Independently update, revise, and finalize regulatory documents, including protocol and IB Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2-5) across the submission lifecycle (responses, amendments, briefing packages) Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards Support intermittent workload demands (~10-15 hours/week during active project periods) Qualifications Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages) Ability to work independently with minimal oversight in a fast-paced, cross-functional environment Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards Proven collaboration experience with regulatory, clinical, and medical writing teams

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