Senior Manager, REMS Operations

BioSpace; California; Remoto; USD 142.000 - 212.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical Insurance

Dental Insurance

Vision Insurance

401k

Flexible paid vacation

Descrizione del lavoro

Jazz Pharmaceuticals, a global biopharma company, is seeking a Senior Manager, REMS Operations to oversee U.S. FDA-mandated REMS programs.

You will drive governance, ensure regulatory compliance, and coordinate with internal teams and external vendors to deliver program milestones. You will manage day-to-day REMS operations, monitor program health, mitigate risks, and maintain documentation for inspections, audits, and governance activities.

Competenze

• 4–6 years of experience in the pharmaceutical industry.
• 2 years of pharmaceutical Project/Program Management experience preferred.
• Experience in REMS and vendor management is preferred.
• Proficient in Microsoft Office Suite.

Mansioni

• Manage day-to-day operations of U.S. FDA-mandated REMS programs with compliance.
• Provide strategic oversight of REMS initiatives and objectives.
• Coordinate REMS governance and operational workstreams and minutes.
• Monitor REMS program health, identify risks and mitigation.
• Partner with cross-functional teams and vendors to execute REMS requirements.
• Maintain documentation for inspections, audits and governance activities.

Conoscenze

Communication skills

Organization

Remote work capability

Self-discipline

Microsoft Office

Formazione

Bachelor's degree

Strumenti

Microsoft Office

Descrizione del lavoro

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 Senior Manager, REMS Operations role is responsible for supporting the operational oversight, and execution of all U.S. FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for Jazz Pharmaceuticals. This role provides end-to-end operational management for REMS programs by ensuring compliance with regulatory requirements, driving governance, mitigating operational risk, and fostering cross-functional collaboration with internal stakeholders and external REMS vendors. This role oversees REMS operational planning and execution, coordinates governance and operational activities, manages vendor performance, and ensures timely completion of program deliverables while supporting continuous process improvement and overall program effectiveness.

Essential Functions/Responsibilities

• Manage the day-to-day operations of the U.S. FDA-mandated REMS programs, ensuring compliance with regulatory requirements and internal governance standards.
• Provide strategic oversight of REMS initiatives, ensuring timely execution of program objectives and alignment to organizational priorities.
• Coordinate REMS governance and operational workstreams, including agenda development, meeting facilitation, timeline management, documentation of meeting minutes, and follow-up on action items with cross-functional stakeholders.
• Monitor overall REMS program health by proactively identifying risks, dependencies, resource constraints, operational issues, and implementing mitigation strategies to support business continuity.
• Partner with cross-functional teams and external vendors to execute REMS program requirements and drive operational excellence.
• Maintain accurate documentation and records to support regulatory inspections, audits, and internal governance activities.

Required Knowledge, Skills, And Abilities

• A minimum of 4-6 years of experience in the pharmaceutical industry.

Experience In REMS And Vendor Management Is Preferred.

• A minimum of 2 years of pharmaceutical Project and/or Program Management experience
• 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 (or equivalent) 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: $141,600.00 - $212,400.00.

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.