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 exposu...