Medical Writer / Clinical Document - Remote
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.
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