Senior REMS Project Management (Remote)

MedStar Health; Philadelphia (Philadelphia County); Remote; USD 136,000 - 204,000; Full time

Job summary

A leading biopharma company is seeking a Senior Manager for REMS Project Management to oversee FDA mandated Risk Evaluation and Mitigation Strategy programs. The role involves project management, coordination with internal teams and vendors, and presentation to senior leadership. Ideal candidates will have substantial experience in the pharmaceutical industry along with healthcare regulatory insight, and the capacity to manage multiple responsibilities efficiently.

Benefits

Medical, dental and vision insurance

401k retirement savings plan

Flexible paid vacation

Discretionary cash bonus

Discretionary equity grants

Qualifications

• 4-6 years of experience in the pharmaceutical industry with REMS Development.
• 2 years of project management experience.
• Self-sufficient in remote work environment.

Responsibilities

• Manage U.S. FDA mandated REMS programs.
• Oversee development and modification of REMS stakeholder materials.
• Coordinate internal and external REMS meetings.

Skills

Project Management

Communication Skills

Attention to Detail

Organization

Education

Bachelor's degree in relevant field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

United States, Pennsylvania, Philadelphia

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.

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 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.

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