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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.
Brief Description: The Manager, Medical Safety Operations, will be responsible for coordinating and managing the operational aspects and supporting the strategies of Medical Safety including the Organ Safety Advisory Panel (OSAP), Coffee Connection and other medical safety initiatives. This role will combine knowledge of PV with strong project management, operational and interpersonal skills to ensure smooth execution of the strategies of Medical Safety and oversight, documentation and execution of OSAP / Medical Safety Governance activities. The role will also support key operations related to Medical Safety such as process development/improvement (SOP/WI), audit/inspection-related activities, contracts, procurement, healthcare professional (HCP) engagement, and cross-functional collaboration to meet strategic objectives for Medical Safety / GRADS organization. Essential Functions/Responsibilities Working closely with the Medical Safety Leadership Team, the Manager, Medical Safety Operations, is expected to:
Manage and coordinate Operations of Medical Safety-related activities Provide strategic support of Medical Safety-initiatives Develop and maintain OSAP charters, governance documents, and procedural guidelines. Lead planning and execution of OSAP meetings, including agenda development, scheduling, pre-read preparation, logistics, meeting facilitation, interacting with presenting project teams, taking and archiving meeting minutes. Track and document OSAP action items, and follow-up activities to ensure timely completion/escalation Serve as the primary point of contact for OSAP operations, ensuring effective and timely communication across Medical Safety, Clinical Development, and other relevant stakeholders, such as internal and external experts. Serve as primary point of contact for procurement system (e.g., Coupa) transactions and approvals related to medical safety activities.
Coordinate HCP engagement logistics (e.g. contracting, non-compete agreement, FMV) in compliance with company standards. Manage project team spaces (e.g., SharePoint, MS Teams) for effective communication and collaboration. Identify process gaps related to Medical Safety and drive process (SOP/WI) development, improvement and training to ensure full compliance with world-wide regulations Assess regulatory intelligence impacting Medical Safety and collaborate with key stakeholders (e.g., QPPV, GRADS Compliance) to update or develop procedures ensuring regulatory compliance and operational excellence. Collaborate with GRADS Alliance Management, Legal, Finance, and Procurement to ensure timely and compliant contract processing. Support additional medical safety initiatives requiring project management, coordination, and documentation. Participate in cross-business partnership projects described in the SDEA, internal audits and Health Authority inspections, as required. Required Knowledge, Skills, and Abilities Minimum of 3 years of experience in PV / safety operations, pharmaceutical project management (PMP certification or equivalent project management training preferred). A minimum facility with comprehension and analysis of PV-related scientific information including being able to rapidly assimilate scientific terminology and understand the logical inferences about cause and effect. Experience managing contracts and governance documentation, with a strong understanding of project management principles and tools. Excellent organizational, prioritization, communication, and facilitation skills. Skilled in managing multiple priorities. Ability to work independently with minimal supervision while fostering team collaboration. Proficiency in Microsoft Office Suite, with the ability to quickly learn new software and database systems. Required/Preferred Education and Licenses A minimum of Bachelor’s degree (preferably a Master’s degree) in life sciences, public health, or related scientific/technical field, such as RN, PharmD, MPH, or Pharmaceutical Sciences. #LI-Remote 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: $128,000.00 - $192,000.00 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 .