Manager, REMS Operations and Compliance (Remote)

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

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.

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