Senior Manager, Epidemiology

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.

Brief Description: A Senior Manager (SM) of Epidemiology will support the epidemiological activities of Jazz’ Global Research & Development (R&D) organization. This role will be responsible for the scientific leadership and operational management of non-interventional pharmacoepidemiology studies, including studies designed to address Jazz’s post-marketing requirements/commitments (PMR/PMC) to regulatory authorities. This role will also be responsible for identifying relevant epidemiology data for regulatory submissions and documents developed to support clinical development of investigational medicines in Jazz’ R&D portfolio, including Risk Management Plans (RMPs), Periodic Benefit-Risk Reports (PBRERs), orphan designation applications and others. The SM will report to the Senior Director of Epidemiology. Essential Functions/Responsibilities Conduct/outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, and cross-sectional studies describing the demographics, co-morbidities, treatment patterns and concomitant medications of the target patient populations in different geographies Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs (e.g., RMPs, safety query responses, orphan drug applications, pediatric waivers, and external control arms) and other processes requiring epidemiological data Provide top of the patient funnel data for forecasting/commercial purposes Identify appropriate US and EU secondary data sources for studying the target patient populations (e.g., administrative claims and electronic medical records (EMR) databases) Lead Requests for Proposal (RFP) and Statement of Work for soliciting proposals and budgets from CROs and Data Providers for outsourced epidemiology studies Support a multi-disciplinary non-interventional Phase IV study team to deliver study-related regulatory submissions (e.g., protocols, statistical analysis plans, progress reports, interim study results and final study reports) in accordance with applicable regulatory guidelines and the PMR/PMC timetable set by a Health Authority Develop statistical analysis plans in collaboration with the project biostatistician (including those for analyses of administrative claims and EMR databases) Manage external investigators, project managers and operational leads at Contract Research Organizations (CROs) and/or Data Providers for outsourced studies to deliver high-quality results on time Communicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMC Develop strong partnerships with internal stakeholders (e.g., Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs) to ensure that the appropriate epidemiological support is provided in their respective processes Communicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on time