Job Description
Key Deliverables:
- Prepare regulatory documents ensuring anonymization and redaction compliance
- Develop and maintain written redaction strategies for studies/products
- Coordinate with cross-functional teams for review and timely submission
- Support trend analysis and clinical disclosure process improvement
Role Responsibilities:
- Interpret and apply clinical data within regulatory frameworks
- Follow SOPs and controlled processes for document preparation
- Manage timelines and priorities to meet disclosure deadlines
- Communicate and escalate document or strategy issues as needed
Skills Required
regulatory documentation, Clinical Trials, Project Management
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