Review all SpeakUp reports to identify emerging trends and create and implement relevant risk mitigation plans; Conduct or oversee internal investigations for the global organization from intake to closure; Supervise regional compliance investigators and other internal and external compliance resources as they conduct investigations. Advise on and, where appropriate, mana

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The Mgr, Regulatory Compliance is responsible for the daily oversight and management of compliance activities across the assigned Horizon Line of Business (LOB). This position ensures that the Enterprise operates in compliance with applicable federal and state laws and regulations. The Manager will advise and influence business leaders across functional areas and implemen

A day in the life of a Senior Regulatory Specialist at Hackensack Meridian Health includes Assists with the management and oversight for all clinical investigators Good Clinical Practice and Human Subjects Training certification documents and medical licenses. This includes a. Collaborates with nurse educators on maintaining current GCP and Human Subjects training certifi

The export controls specialist will provide experience and subject matter expertise in the areas of export controls and support other research compliance initiatives as requested by Office of Research leadership (e.g., research related COIs). The incumbent will Independently review and provide guidance on contracts for export control and research security compliance. They

Rutgers, The State University of New Jersey is seeking a Principal Auditor for Office of Audit and Advisory Services. Reporting to the Audit and Advisory Services' ( AAS ) Manager of Audit and Advisory Services Financial, Operational, and Investigations, the Principal Auditor position exists to provide professional, independent, objective assurance and consulting services