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Clinical Study Report Writer Jobs (NOW HIRING)

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Reports can be clinical or non-clinical in nature providing insight into clinical workflows ... study. * Experience writing and analyzing SQL queries - MS SQL, Oracle * Healthcare related ...

Writes and/or edits clinical documents for submission to the FDA and other regulatory agencies. Is ... Interacts regularly with clinical teams to establish and review timeline for clinical study report ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

Regulatory Medical Writing * Clinical Study Report (CSR) Authoring * ICH E3 Guidelines * Scientific Accuracy Assessment * Source Data Verification * Clinical Protocol Interpretation * TFL Analysis ...

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Clinical Study Report Writer information

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$54

$83

How much do clinical study report writer jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for clinical study report writer in the United States is $54.35, according to ZipRecruiter salary data. Most workers in this role earn between $39.90 and $64.18 per hour, depending on experience, location, and employer.

What are popular job titles related to Clinical Study Report Writer jobs?

For Clinical Study Report Writer jobs, the most frequently searched job titles are:

Medical Writer / Clinical Document - Remote

YO AI Labs

New York, NY • Remote

$50 - $80/hr

Full-time

Re-posted yesterday


Job description

Job Title: Medical Writer / Clinical Document Author

Location: Remote
Job Type: Contractor
Pay: $50–$80/hour

Job Overview

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 Responsibilities
  • Author 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.

Required Skills
  • 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

Qualifications
  • 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.