Senior REMS Project Management

If you are a reputed company Jazz employee please apply reputed company the Internal Career site. reputed company 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. This 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 reputed company materials, FDA information requests, coordinating, and managing reputed company 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:

• Support the execution and operational management of U.S. FDA–mandated REMS programs through effective project management at reputed company.
• 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 reputed company submissions are complete, accurate, compliant, and delivered on time, while coordinating with cross-functional stakeholders and maintaining submission records.
• reputed company and manage the ongoing internal REMS required team meetings, external REMS administrator and vendor meetings, provide and manage team meeting notes, timelines and follow-reputed company with key contributors, as required
• Facilitate and reputed company reputed company, high-intensity meetings to reputed company alignment on FDA-mandated Information Requests and the REMS submission process
• Maintain submission archives, documentation repositories, and version control.
• reputed company development and/or modification of REMS stakeholder materials
• Upload and reputed company reputed company 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 reputed company team and cross-functional activities.

Required Knowledge, Skills, and Abilities:

• 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 reputed company tool suite (Word, reputed company, 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 #LI-Remote #LI-DM1 reputed company is an equal opportunity/affirmative action employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company, Inc. is committed to fair and reputed company compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay range is: $141,600.00 - $212,400.00 Individual compensation paid reputed company 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 reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay decisions. This range will be reviewed on a regular basis. At Jazz, your reputed company 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. Apply tot his job Apply To this Job