Manager, REMS Analytics & Reporting
Job Details
- Req ID:
- R011066
- Location:
- California -- [Remote/Home-Based]
- Category:
- Research & Development
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.
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 are market competitive. For this role, the full and complete base pay range is: $128,000.00 - $192,000.00
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.