Austin, TX · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
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Austin, TX · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
Boston, MA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
Quick apply
Boston, MA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
Seattle, WA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
Quick apply
Seattle, WA · Remote
$50 - $80/hr
Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50-$80/hour ... Interpret clinical protocols and ensure compliance with ICH guidelines. * Verify scientific ...
Austin, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Austin, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
San Jose, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
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San Jose, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Atlanta, GA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
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Atlanta, GA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Seattle, WA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
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Seattle, WA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Seattle, WA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Seattle, WA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
New York, NY · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
New York, NY · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Boston, MA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Boston, MA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Dallas, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
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Dallas, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Los Angeles, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Los Angeles, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Palo Alto, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Palo Alto, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Boston, MA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Boston, MA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Houston, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Houston, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Austin, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Austin, TX · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Chicago, IL · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Chicago, IL · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
San Francisco, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
San Francisco, CA · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Phoenix, AZ · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Phoenix, AZ · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Washington, DC · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
Quick apply
Washington, DC · Remote
$50 - $80/hr
Clinical Protocol Interpretation * TFL Analysis * eCTD Knowledge * Strong Written Communication & Collaboration Qualifications * 5+ years of regulatory medical writing experience in a Sponsor, CRO ...
$25 - $30.31
10% of jobs
$30.31 - $35.62
9% of jobs
$39.07 is the 25th percentile. Wages below this are outliers.
$35.62 - $40.93
11% of jobs
$40.93 - $46.24
2% of jobs
$46.24 - $51.55
1% of jobs
The median wage is $55.31 / hr.
$51.55 - $56.86
26% of jobs
$56.86 - $62.17
15% of jobs
$63.28 is the 75th percentile. Wages above this are outliers.
$62.17 - $67.48
13% of jobs
$67.48 - $72.79
10% of jobs
$72.79 - $78.10
4% of jobs
$78.10 - $83.41
1% of jobs
$25
$54
$83
A Clinical Protocol Writer is responsible for drafting and developing clinical trial protocols that outline study objectives, methodologies, patient eligibility criteria, and regulatory requirements. They work closely with clinical researchers, regulatory teams, and medical writers to ensure protocols align with industry and compliance standards. Their role is crucial in guiding the execution of clinical trials and ensuring data integrity. Strong writing, attention to detail, and knowledge of regulatory guidelines are essential for success in this role.
A Clinical Protocol Writer is responsible for drafting and revising clinical trial protocols, ensuring compliance with regulatory guidelines, and incorporating feedback from cross-functional teams such as clinical operations, biostatistics, and regulatory affairs. On a typical day, you may coordinate with investigators, review scientific literature, and attend meetings to discuss study design and objectives. You’ll also manage document version control and ensure timely delivery of protocol drafts and amendments. This role requires balancing independent writing tasks with frequent team collaboration to align clinical documentation with study goals and regulatory standards.
To thrive as a Clinical Protocol Writer, you need expertise in clinical research, scientific writing, and regulatory requirements, typically supported by a bachelor's or advanced degree in life sciences or a related field. Familiarity with tools like Microsoft Office, clinical trial management systems (CTMS), and knowledge of ICH-GCP guidelines or similar certifications are highly valued. Strong attention to detail, collaboration skills, and the ability to translate complex scientific concepts into clear, compliant documents set top candidates apart. These skills are essential for generating precise, regulatory-ready protocols that ensure accurate clinical trial execution and cross-team collaboration.
The most popular types of Clinical Protocol Writer jobs are:
The top searched job categories for Clinical Protocol Writer jobs are:
$50 - $80/hr
Full-time
Posted 12 days ago
Location: Remote
Job Type: Contractor
Pay: $50–$80/hour
We are seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.
Key ResponsibilitiesAuthor and review Clinical Study Reports (CSRs) and other regulatory documents.
Interpret clinical protocols and ensure compliance with ICH guidelines.
Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.
Review safety documentation, including DSURs and PSURs/PBRERs.
Provide structured feedback and collaborate with cross-functional teams.
Support AI-assisted documentation evaluation and quality improvement initiatives.
Regulatory Medical Writing
Clinical Study Report (CSR) Authoring
ICH E3 Guidelines
Scientific Accuracy Assessment
Source Data Verification
Clinical Protocol Interpretation
TFL Analysis
eCTD Knowledge
Strong Written Communication & Collaboration
5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.
Experience authoring Clinical Study Reports and regulatory documentation.
Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).
Experience in oncology and haematology is preferred.