Senior REMS Project Management (Remote)

Jazz Pharmaceuticals; 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 support FDA-mandated programs. This remote role involves coordinating REMS initiatives, managing teams, and ensuring compliance with regulatory requirements, ideal for experienced project managers in health sciences.

Benefits

Medical, dental, and vision insurance

401k retirement savings plan

Flexible paid vacation

Discretionary annual cash bonus

Qualifications

• 4-6 years in the pharmaceutical industry, with 2-3 years in REMS development.
• 2+ years project management experience.
• Excellent oral and written communication skills.

Responsibilities

• Manage U.S. FDA mandated REMS programs.
• Organize team meetings and manage timelines.
• Oversee REMS stakeholder materials development.

Skills

Project Management

Communication

Organizational skills

Education

Bachelor's degree in relevant field

Tools

Microsoft Office Suite

Job description

Join to apply for the Senior REMS Project Management (Remote) role at Jazz Pharmaceuticals

15 hours ago Be among the first 25 applicants

Join to apply for the Senior REMS Project Management (Remote) role at Jazz Pharmaceuticals

Get AI-powered advice on this job and more exclusive features.

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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Information Technology

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Jazz Pharmaceuticals by 2x

Sign in to set job alerts for “Senior Project Management” roles.

Philadelphia, PA $104,040.00-$139,310.00 2 weeks ago

Technical Operations Manager - 100% REMOTE

Philadelphia, PA $80,000.00-$130,000.00 2 days ago

Senior Staff Engineering Manager of Financial Data and Analytics

Philadelphia, PA $150,000.00-$300,000.00 2 days ago

Senior Staff Engineering Manager of Financial Data and Analytics

Marlton, NJ $150,000.00-$300,000.00 2 days ago

Philadelphia, PA $125,000.00-$150,000.00 1 week ago

Senior Staff Engineering Manager of Financial Data and Analytics

Wilmington, DE $150,000.00-$300,000.00 2 days ago

Associate Director, Regulatory Medical Writing - Oncology

Horsham, PA $137,000.00-$235,750.00 2 days ago

Associate Director, Regulatory Medical Writing - Oncology

Spring House, PA $137,000.00-$235,750.00 2 days ago

Senior Project Manager – MEP & Process Engineering

Philadelphia, PA $140,000.00-$160,000.00 1 day ago

Senior Civil Engineering Project Manager Remote - Philadelphia, PA

Philadelphia, PA $120,000.00-$150,000.00 1 week ago

Project Manager – Supply Chain / Distribution

Sr Process Engineer/Project Manager (Pharma/Healthcare/MEP)

Philadelphia, PA $115,000.00-$150,000.00 18 hours ago

Malvern, PA $114,400.00-$171,600.00 1 week ago

Radnor, PA $93,300.00-$169,700.00 2 weeks ago

Philadelphia, PA $110,000.00-$130,000.00 1 week ago

King of Prussia, PA $200,000.00-$250,000.00 2 weeks ago

Senior Staff Engineer - Finance Data Specialist (Remote)

Philadelphia, PA $115,000.00-$260,000.00 1 day ago

Senior Staff Engineer - Finance Data Specialist (Remote)

Wilmington, DE $115,000.00-$260,000.00 1 day ago

Philadelphia, PA $175,000.00-$175,000.00 4 weeks ago

Project Manager/Administrator - FULLY REMOTE

Operational Transformation Project Manager (Remote)

Fort Washington, PA $75,000.00-$90,000.00 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.