New

Manager, REMS Operations and Compliance (Remote)

Jazz Pharmaceuticals
$120,000.00 - $180,000.00
vision insurance, 401(k), remote work
United States, Pennsylvania, Philadelphia
Mar 18, 2025
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. 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 Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $120,000.00 - $180,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.