Manager, REMS Analytics & Reporting

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

Brief Description:

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. Alignment with other cross-functional areas will be critical to success and will require collaboration across multiple departments.

Essential Functions/Responsibilities

• 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

• May mentor RSO team members, as needed

Required Knowledge, Skills, and Abilities

• 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; REMS experience preferred

• Experience with Individual Case Safety Report (ICSR) processing and safety database applications (e.g., Argus, ARISg)

• 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)

• Excellent written and verbal communication skills

• Highly organized with strong attention to detail

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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 ar