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Remote Regulatory Writing Jobs (NOW HIRING)

Olema Oncology

Lead Senior Medical Writer

San Francisco, CA · On-site +1

$160K - $175K/yr

Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer ... Experience working in hybrid/remote environments Attributes: * Teamwork and collaboration; balances ...

Mercor

Regulatory Counsel

New York, NY · Remote

$85 - $120/hr

Remote Commitment: 20-40 hours/week Role Responsibilities * Design realistic regulatory scenarios from your practice, such as AML/SAR preparation , OFAC screening , and FCPA assessments . * Write ...

GlaxoSmithKline

Principal Medical Writer

Durham, NC · On-site +1

Act as a subject matter expert on medical writing standards, document structure, and regulatory ... Experience working in multicultural or remote team settings. * Proven ability to independently ...

ViiV Healthcare

Principal Medical Writer

Durham, NC · On-site +1

Act as a subject matter expert on medical writing standards, document structure, and regulatory ... Experience working in multicultural or remote team settings. * Proven ability to independently ...

Brightwing

Regulatory Coordinator

Chicago, IL · Remote

$40 - $48/hr

Remote role in the United States Under general supervision, work with the Senior Manager Regulatory ... written communication and organizational skills Experience with MS Office Suite and Ithos a plus ...

LivaNova

Regulatory & Clinical Specialist

Chicago, IL · Remote

$85K - $95K/yr

... writing and medical device regulatory affairs or a Ph.D. with at least 3 years of experience Location & Travel Requirements * This is a remote role (candidates must be based in the United States)

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Remote Regulatory Writing information

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How much do remote regulatory writing jobs pay per hour?

As of Jun 19, 2026, the average hourly pay for remote regulatory writing in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Remote Regulatory Writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
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Remote Regulatory Writing jobs near you
Director, Regulatory & Medical Writing (Remote Eligible)

Director, Regulatory & Medical Writing (Remote Eligible)

IDEAYA Biosciences

South San Francisco, CA • On-site, Remote

$211K - $258K/yr

Full-time

Medical, Retirement

Posted 22 days ago

Job description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The Director, Regulatory & Medical Writing is responsible for strategically managing medical writing resources to support Denali's development programs and ensuring the timely delivery of high-quality regulatory documents and publications. This role provides leadership and oversight of regulatory document development processes and continuously improving those processes to enhance efficiency, quality, and consistency across programs. The individual in this role also communicates effectively and persuasively cross-functionally; and serves as a key partner to various functions within Development at Denali in support of Denali's product development and company goals.

Key Accountabilities/Core Job Responsibilities:

  • Develops and executes on a resource plan (using both internal and external resources) to support medical writing and editing efforts for all Denali-developed regulatory documents

  • Manages and continuously improves Denali's regulatory document development process

  • Supports Development authors to ensure efficient development of high-quality regulatory documents while meeting agreed-to document development timelines.

  • Manages Smartsheet environment and templated timelines for regulatory documents including reports and dashboards

  • Establishes and maintains cross-functional relationships in support of program goals; persuades and influences both internal and external stakeholders.

  • Identifies the need for and leads non-program initiatives and activities.

  • Supports development and maintenance of regulatory document templates and style guide(s).

  • Maintains up-to-date knowledge of the regulations and guidelines related to regulatory document structure and content as well as GxP quality standards.

  • Participates in relevant industry groups

Qualifications/Skills:

  • BS or BA in science/technology or an equivalent combination of education and experience

  • 10+ years of relevant work experience required, including 7+ years of medical writing

  • Strong working knowledge of regulatory document development standards and best practices.

  • Advanced skills in the use of MS Word and Smartsheet; experience working in SharePoint and Veeva RIM.

  • Excellent communication skills and effective in a collaborative team environment.

  • Ability to work independently and to be innovative in tackling operational challenges.

Salary Range: $211,000.00 to $258,667.00 .Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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