Senior REMS Project Management (Remote)

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

As a member of the REMS Strategy and Operations department, the Senior Manager REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. Role will support the Director level of the department in multiple department initiatives in the US. This role provides management and ongoing development and review of staging of REMS Document and related materials, FDA information requests, coordinating and managing related REMS team meetings for internal Jazz teams, external REMS administrator, or REMS vendors. Role will provide information of ongoing projects and initiatives to senior management as required. Support presentation development and delivery to senior leadership.

Essential Functions/Responsibilities

• Project management for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs at Jazz Pharmaceuticals. 
• 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
• Stage all new and existing REMS documents and materials as necessary for new REMS program requirements, or modifications to current REMS programs, as requested
• 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
• Manage REMS contractor vendors, work orders, and department budgets; ensure all REMS vendor contracts and work orders are in good standing and in place prior to work commencing or continuing and obtain necessary reviews and approvals from Jazz stakeholders.
• Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities.  
• Support daily function for support of multiple product responsibilities to meet REMS requirements.  

Required Knowledge, Skills, and Abilities

• A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years’ experience in REMS Development
• A minimum of 2 years pharmaceutical Project Management experience
• ​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. 

Required/Preferred Education and Licenses

• ​Bachelor's degree (or equivalent) in relevant field, required 

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:

$136,000.00 - $204,000.00

Individual compensation paid within this range will depend on many fac