Opportunity Description
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 ...
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 ...
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