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Medical Writer / Clinical Document - Remote

$50 - $80 per hour

YO AI Labs

Houston, TX
  • Remote job

Job Description

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.

Vacancy posted 19 days ago
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