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

life-changing medicines for people with serious diseases — often with limited or no

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. As a member of the REMS Strategy & Operations (RSO), the Manager of REMS Analytics & Reporting will support various aspects of the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs to ensure product and patient safety. This role will be accountable for the execution, analysis, and quality of REMS assessments and reporting, overseeing assigned sections of reports, coordinating vendors and stakeholders, and supporting timely, high-quality regulatory deliverables under the guidance of the Associate Director of REMS Analytics & Reporting. Oversee and be responsible for the development of assigned sections of the REMS Assessment Report, including data interpretation and narrative development, ensuring accuracy, consistency, and compliance with operational practices and regulatory requirements

Manage data collection, validation, quality control, and documentation to support REMS Annual Timetable Assessments

Review FDA information requests and contribute to responses with data analysis, interpretation, and documentation

Conduct analytical assessments, including metric development, trend analysis, and performance monitoring, providing insights to support decision-making

Oversee and coordinate with external vendors and REMS stakeholders to manage data exchanges, ensure data quality, timeliness, and adherence to reporting and regulatory requirements

Support REMS-related audit and inspection readiness activities and identify gaps or opportunities for process improvement

Ensure compliance with corporate and departmental SOPs and completion of required training

Collaborate cross-functionally to align REMS analytics and reporting activities and proactively resolve issues affecting timelines or quality

Life sciences industry experience with a Bachelor/Master’s degree in life sciences, public health, clinical research, health informatics, data science, or a related field,

Experience in data management and analysis; Experience with Individual Case Safety Report (ICSR) processing and safety database applications (e.g., Knowledge of MedDRA and WHO Drug Dictionary coding

Experience in medical writing, including preparation and review of reports and regulatory documents

Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)

LI-remote

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.

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. Internal equity considerations will also influence individual base pay decisions. 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.