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.
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.
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
Medical Writer - Remote
Palo Alto, 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 ...
Quick apply
Medical Writer - Remote
Palo Alto, 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 ...
Medical Writer - Remote
Austin, 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 ...
Quick apply
Medical Writer - Remote
Austin, 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 ...
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
Medical Writer - Remote
Chicago, IL · 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 ...
Quick apply
Medical Writer - Remote
Chicago, IL · 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 ...
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
Medical Writer - Remote
Philadelphia, PA · 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 ...
Quick apply
Medical Writer - Remote
Philadelphia, PA · 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 ...
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 ...
Quick apply
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 ...
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 ...
Quick apply
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 ...
Medical Writer - Remote
San Francisco, 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 ...
Quick apply
Medical Writer - Remote
San Francisco, 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 ...
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 ...
Quick apply
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 ...
Medical Writer - Remote
Dallas, 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 ...
Quick apply
Medical Writer - Remote
Dallas, 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 ...
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 ...
Quick apply
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 ...
Medical Writer / Clinical Document - Remote
San Jose, CA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...
Quick apply
Medical Writer / Clinical Document - Remote
San Jose, CA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Author and review Clinical Study Reports (CSRs) and other regulatory documents. * Interpret ...
Regulatory Medical Writer information
See salary details
$14.18 - $18.16
3% of jobs
$18.16 - $22.14
9% of jobs
$26.03 is the 25th percentile. Wages below this are outliers.
$22.14 - $26.11
13% of jobs
$26.11 - $30.09
7% of jobs
$30.09 - $34.07
8% of jobs
$34.07 - $38.05
5% of jobs
The median wage is $39.79 / hr.
$38.05 - $42.02
8% of jobs
$42.02 - $46
16% of jobs
$47.54 is the 75th percentile. Wages above this are outliers.
$46 - $49.98
12% of jobs
$49.98 - $53.96
7% of jobs
$53.96 - $57.93
11% of jobs
$14
$38
$57
How much do regulatory medical writer jobs pay per hour?
How much does a regulatory medical writer make?
Is there a demand for regulatory medical writers?
What are the key skills and qualifications needed to thrive as a regulatory medical writer?
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 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?
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.
Do regulatory medical writers make good money?
What cities are hiring for Regulatory Medical Writer jobs?
Cities with the most 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:
What states have the most Regulatory Medical Writer jobs?
States with the most job openings for Regulatory Medical Writer jobs include:
What job categories do people searching Regulatory Medical Writer jobs look for?
The top searched job categories for Regulatory Medical Writer jobs are:

Senior Regulatory Medical Writer - Fractional (Remote)
Fairfield, CT • Remote
Full-time
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
About Penfield Search Partners
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Fairfield, CT, US
Year founded
2012