Medical Writer - Remote

Job Title: Medical Writer Expert Remote 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. #J-18808-Ljbffr YO AI Labs