Scientific Writer - Clinical Narratives

Requirement overview: Role: Scientific Writer – Clinical Narratives Number of resources: 2 Duration: 12 months Location: Hyderabad Onsite Scope of work: The resources will be responsible for end-to-end development of patient safety narratives supporting Clinical Study Reports (CSRs) for submissions to regulatory authorities (e.G., FDA, EMA). This includes: Drafting, editing, review, and finalization of narratives Interpreting data from clinical and safety databases Ensuring medical accuracy, clarity, and regulatory compliance Managing timelines and deliverables for assigned studies Performing quality control checks and ensuring formatting consistency Contributing to process improvement initiatives Given the nature of work, prior experience in clinical/regulatory writing and exposure to global regulatory submissions will be critical.