Opportunity Description
Key Responsibilities
- Manage submission‑readiness of clinical documents, ensuring compliance with regulatory requirements and quality standards
- Oversee technical editorial and formatting of clinical documents for regulatory submissions
- Ensure clinical documentation meets Health Authority guidelines, Good Clinical Practice, and Novartis procedures
- Support implementation of submission readiness strategies and standardized document templates
- Collaborate with cross‑functional teams to deliver high‑quality documents within timelines
- Monitor vendor performance, track service metrics, and drive continuous‑improvement initiatives
- Act as escalation point for submission readiness issues and resolve operational challenges
- Identify risks, trends, and gaps in submission processes and implement appropriate mitigations
- Serve as Subject Matter Expert for submission readiness processes, tools, and train...
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