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Associate Submission Manager
3 months ago
Your responsibilities include, but are not limited to:
Provide operational support to the BR Submission manager with many of the tasks involved with the smooth running of regulatory submission preparation in compliance with Novartis processes.
Collaborate with the SM in taking action to address issues as they arise. Ensure all assigned submission related activities are completed in compliance with in-ternal departmental process, SOP, and health authority guidance.- May distribute workload to external vendor. Regularly maintain supporting IT systems/trackers to ensure accuracy of information by liaising with stakeholders. Provide operational support for selected CS&I and/or TM departmental compliance and submission activities, including deliverable tracking, issue reporting and escalation; ensuring stakeholders are held accountable for agreed actions and deliverables.
- May coordinate activities associated with the preparation of Clinical Trial Application submissions following internal working practice, guidance, and SOPs to ensure the delivery of high-quality submission documents to regulatory operations.
This includes creation of requisite templates, drafting of timelines, ensuring documents are finalized according to internal process via source data verification and formatting checks in accordance with agreed timelines.
- Manage the preparation activities associated with the IB compilation of TM-DP led IB annual updates in compliance with internal SOP and health authority requirements. Organizing and chairing the kick-off meeting to establish the level of update and contributors across Biomedical Research Translational Medicine and Development.
- Leads subsequent IB planning discussions, creating, and maintaining a comprehensive project plan capturing actions and key activities, target governance board review, content delivery timelines, and finalization date for IB. Manage stakeholder engagement, and ensure that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly and remediated.
- Timely escalation (as per agreed process) if the IB will not be finalized within the annual update period. Collaboration with Document Quality Management team to ensure strategic resource planning of downstream activities allowing IB to be finalized in accordance with targeted timelines.
