Medical Writer Remote

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.

• 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.

• 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.