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Full Time Regulatory Medical Writer Jobs (NOW HIRING)

YO AI Labs

Medical Writer - Remote

New York, NY · Remote

$50 - $80/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Phoenix, AZ · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Seattle, WA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Boston, MA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Los Angeles, CA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Atlanta, GA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Washington, DC · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Seattle, WA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Miami, FL · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

San Jose, CA · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

YO AI Labs

Medical Writer - Remote

Houston, TX · Remote

$50 - $90/hr

Medical Writer Expert Remote Location: Remote Job Type: Contractor Pay: $50-$80/hour Job Overview ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...

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Full Time Regulatory Medical Writer information

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How much do full time regulatory medical writer jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for full time 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.

What is the difference between Full Time Regulatory Medical Writer vs Clinical Writer?

AspectFull Time Regulatory Medical WriterClinical Writer
Required CredentialsLife sciences degree, medical or scientific background, often regulatory certificationsLife sciences degree, scientific background, may have regulatory or clinical certifications
Work EnvironmentPharmaceutical, biotech, or regulatory agencies; office or remoteClinical research organizations, pharmaceutical companies, or academic settings
Employer & Industry UsagePrimarily in regulatory affairs within pharma/biotechIn clinical research, data analysis, and study documentation

Full Time Regulatory Medical Writers focus on preparing regulatory documents for drug approval processes, requiring regulatory knowledge and certifications. Clinical Writers typically work on clinical study reports and protocols, often with a clinical research background. While both roles require scientific expertise, Regulatory Medical Writers specialize in regulatory submissions, whereas Clinical Writers focus on clinical trial documentation.

What cities are hiring for Full Time Regulatory Medical Writer jobs?

Cities with the most Full Time Regulatory Medical Writer job openings:

What are the most commonly searched types of Regulatory Medical Writer jobs?

The most popular types of Regulatory Medical Writer jobs are:

Full Time Regulatory Medical Writer jobs near you

Regulatory Medical Writer

3B Staffing LLC

San Rafael, CA • Hybrid

Full-time

Re-posted 16 days ago

Job description

Regulatory Medical Writer

Hybrid (1-2 days onsite) San Rafael CA

The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

RESPONSIBILITIES

  • Drafts and edits documents used for submissions including CTDs and RtQs
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.)
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Works effectively with cross-functional groups within BioMarin • Other tasks as assigned.

Skills:

Fulfills one of the following:

  • Medical writer in the pharmaceutical industry
  • Medical or scientific writing experience as a primary job responsibility

Skill and Experience: At least 6+ years experience required

  • Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
  • Familiar with clinical study data collection and results reporting. • Previous protocol development experience required.
  • Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
  • Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
  • Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
  • Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
  • Ability to interpret basic tabular and graphical clinical data presentations.
  • Ability to create basic tables using AMA style (eg, Schedule of Events).
  • Intermediate applied knowledge of basic clinical laboratory tests.
  • Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
  • Basic understanding of biostatistical and clinical research concepts.Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
  • Experienced with scanners, printers, and copiers.Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
  • Capable of working on multiple tasks and shifting priorities.Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.Good conflict management skills.Motivated and shows initiative.
  • Detail oriented.Capable of well organized, concise and clear written and verbal communication.Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
  • Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

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