Medical Writer / Clinical Document Author at YO AI Labs

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 ResponsibilitiesAuthor 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 SkillsRegulatory Medical WritingClinical Study Report (CSR) AuthoringICH E3 GuidelinesScientific Accuracy AssessmentSource Data VerificationClinical Protocol InterpretationTFL AnalysiseCTD KnowledgeStrong Written Communication & CollaborationQualifications5+ 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 rmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).Experience in oncology and haematology is preferred.

Medical Writer / Clinical Document Author

Emma

Responsibilities

Skills wanted:

Language(s) required:

About YO AI Labs:

yoailabs.careers-page.com

Admin access needed