Senior Manager, REMS Data Programmer jobs in United States
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Jazz Pharmaceuticals · 2 days ago

Senior Manager, REMS Data Programmer

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines. The Senior Manager, REMS Data Programmer will support FDA mandated REMS programs and lead programming activities to ensure the delivery of high-quality data while collaborating with cross-functional teams.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Provide support for the development, submission and implementation of U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and Risk Management initiatives conducted for product and patient safety
Provide advanced technical expertise in data programming languages (e.g., SAS, R, Python) and ensure the development of high-quality, efficient, and well-documented code
Collaborate with cross-functional teams to support REMS portal development, implementation, and maintenance, ensuring compliance with REMS requirements
Develop and validate analysis datasets, tables, listings, and figures (TFLs) in accordance with CDISC standards
Develop interactive dashboards to visualize REMS Assessment data, data quality, and key performance met using Power BI
Provide technical guidance and oversight to ensure data programming solutions meet business requirements
Collaborate with Business Analysts and/or Solution architect to design and deliver technical solutions align with business requirements and stakeholder needs
Ensure audit preparedness and support regulatory inspections for REMS
Support daily departmental tasks to meet REMS requirements for multiple products

Qualification

SASRPythonCDISC CertificationBusiness analysisMulti-taskingCommunication skillsInterpersonal skills

Required

A minimum of 6-8 years of experience in the pharmaceutical industry, including at least 3-5 years in data programming, with a focus on REMS programs or similar regulated environments
Advanced technical expertise in data programming languages (e.g., SAS, R, Python)
Proficient in business analysis principles and practices
Excellent communication and interpersonal skills, with ability to effectively communicate complex technical concepts to non-technical stakeholders
Ability to work in a fast-paced environment and manage multiple priorities
Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields

Preferred

CDISC Certification desired
Master's Degree preferred

Benefits

Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation

Company

Jazz Pharmaceuticals

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Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.

H1B Sponsorship

Jazz Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)

Funding

Current Stage
Public Company
Total Funding
$2.81B
Key Investors
Longitude CapitalKohlberg Kravis Roberts
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M

Leadership Team

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Renée Galá
President and Chief Executive Officer
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Ryan Bovia
Senior Vice President, Franchise Head Epilepsy and Movement Disorders
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Company data provided by crunchbase