• Manage the Non-registrational Study Approval Process (NORSAP) for all therapeutic areas including coordinating the meetings, taking minutes, and follow up post meeting as required • Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee • Ongoing management of approved Investigator Initiated Studies (IIS’s) including (but not limited to) contracting, drug supply, study tracking, and close out • Oversees and executes on the end to end US Independent Medical Education grants review and approval process including facilitation of Review Committee Process