Submission Readiness Document Manager

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...