Manager, REMS Operations and Compliance (Remote)

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manager of REMS Operations and Compliance to join their dynamic team. In this pivotal role, you will support FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs, ensuring compliance and operational excellence across various departments. You will actively monitor compliance metrics, prepare training, and facilitate audits, making a significant impact on the organization's success. If you thrive in a collaborative environment and possess a strong background in quality systems and drug safety, this opportunity is perfect for you. Join a forward-thinking company that values innovation and teamwork.

Qualifications

• 2+ years of Quality Systems and/or compliance experience required.
• Experience in Drug Safety/Pharmacovigilance with a focus on REMS.

Responsibilities

• Support daily operations for FDA mandated REMS at Jazz Pharmaceuticals.
• Collaborate with cross-functional teams to support REMS operational requirements.

Skills

Quality Systems

Compliance

Drug Safety/Pharmacovigilance

Training Development

Communication Skills

Attention to Detail

Self-discipline

Education

Bachelor's degree in relevant field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

As a member of the REMS Strategy and Operations team, the Manager of REMS Operations and Compliance will support various aspects of the FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This role will support multiple department initiatives related to REMS operations and REMS compliance. Alignment between this role and other cross-functional areas will be critical to success and will require collaboration across multiple departments and service providers.

Essential Functions/Responsibilities

• Support daily operations for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) at Jazz Pharmaceuticals.
• Active monitoring of inbound REMS required reports, which include Risk Management Reports (RMRs), deviation reports, noncompliance events, and training reports.
• Generate and monitor REMS compliance related metrics.
• Support compliance with REMS requirements and procedures both internally and within approved REMS service providers.
• Collaborate with cross-functional teams to support REMS operational requirements
• Prepare and support all internal & external REMS related trainings.
• Support REMS related audit and inspection readiness activities.
• Provide support for REMS modification activities and review of REMS materials.
• Support daily department functions required to meet business and regulatory requirements within the team.
• Active monitoring of the REMS inbox and dissemination of communications as needed to the appropriate team members.

Required Knowledge, Skills, and Abilities

• 2+ years of Quality Systems (root cause analysis, deviations, CAPAs, etc.) and/or compliance experience required.
• A minimum of 2-4 years of experience in Drug Safety/Pharmacovigilance with a focus on REMS/Quality Systems
• Experience developing and leading effective training preferred.
• Proficient in Microsoft tool suite (Word, Excel, PowerPoint, Outlook).
• Excellent oral and written communication skills.
• Highly organized and demonstrates consistent attention to detail.
• Self-sufficient/discipline for remote work environment.

Required/Preferred Education and Licenses

• Bachelor's degree in relevant field, required