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.