Jazz Pharmaceuticals · 1 day ago
Senior REMS Project Management
United States
Full-time
Remote
Mid, Senior Level
$142K/yr - $212K/yr
4+ years expJazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for patients with serious diseases. The Senior Manager REMS Project Management will support FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs, overseeing project management and regulatory documentation while coordinating with internal and external stakeholders.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Support the execution and operational management of U.S. FDA–mandated REMS programs through effective project management at Jazz Pharmaceuticals
Responsible for the preparation and coordination of REMS regulatory documentation, including tracking submission timelines, managing agency requests and responses, and ensuring timely follow-up, resolution, and submission
Ensures all submissions are complete, accurate, compliant, and delivered on time, while coordinating with cross-functional stakeholders and maintaining submission records
Develop and manage the ongoing internal REMS required team meetings, external REMS administrator and vendor meetings, provide and manage team meeting notes, timelines and follow-ups with key contributors, as required
Facilitate and lead complex, high-intensity meetings to achieve alignment on FDA-mandated Information Requests and the REMS submission process
Maintain submission archives, documentation repositories, and version control
Oversee development and/or modification of REMS stakeholder materials
Upload and route all required REMS documents, materials and FDA Information Requests to internal Jazz stakeholders, as required
Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities
Qualification
Required
A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years' experience in REMS is preferred
A minimum of 2 years pharmaceutical Project Management experience
Ability to create high-quality PowerPoint presentations to support executive communication and project updates, should include layout design, visual storytelling, and template creation
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
Bachelor's degree (or equivalent) in relevant field, required
Preferred
Experience in REMS is preferred
Benefits
Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation
Company
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.
1001-5000 employees
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 CompanyTotal Funding
$2.81BKey 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
Renée Galá
President and Chief Executive Officer
Ryan Bovia
Senior Vice President, Franchise Head Epilepsy and Movement Disorders
Recent News
2026-01-07
Company data provided by crunchbase