Manager of REMS Compliance

A company is looking for a Manager, REMS Operations and Compliance (Remote). Key Responsibilities Support daily operations for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) Monitor inbound REMS required reports and generate compliance-related metrics Collaborate with cross-functional teams and support internal & external REMS trainings Required Qualifications, Training, and Education Bachelor's degree in a relevant field is required 2+ years of Quality Systems and/or compliance experience required 2-4 years of experience in Drug Safety/Pharmacovigilance with a focus on REMS Experience in developing and leading effective training is preferred Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Mar 18, 2025 - 15:01

A company is looking for a Manager, REMS Operations and Compliance (Remote). Key Responsibilities Support daily operations for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) Monitor inbound REMS required reports and generate compliance-related metrics Collaborate with cross-functional teams and support internal & external REMS trainings Required Qualifications, Training, and Education Bachelor's degree in a relevant field is required 2+ years of Quality Systems and/or compliance experience required 2-4 years of experience in Drug Safety/Pharmacovigilance with a focus on REMS Experience in developing and leading effective training is preferred Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook)