Senior Manager, Epidemiology

If you are a current Jazz employee please apply via the Internal Career siteJazz 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 for more information.Job DescriptionBrief 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/ResponsibilitiesConduct/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 geographiesContribute 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 dataProvide top of the patient funnel data for forecasting/commercial purposesIdentify 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 studiesSupport 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 AuthorityDevelop 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 timeCommunicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMCDevelop 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 processesCommunicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on timePresent research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals.Ensure compliance with all applicable laws, regulations and regulatory guidelinesRequired Knowledge, Skills, and AbilitiesAdvanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)At least 2 years of experience in the pharmaceutical industry, CRO or in academiaExperience with rare disease studiesProject management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research studyExperience successfully coordinating cross-functional processesExperience analyzing secondary data sources (administrative claims and EMR databases)Excellent oral and written communication skills in EnglishSolid understanding of epidemiology and biostatisticsExperience managing multiple projects and reprioritizing work when necessaryCapable of working remotely with minimal supervisionProficiency with MS Word, Excel and PowerPointAbility to travel approximately 10% timeRequired/Preferred Education and LicensesTherapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platformExperience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)Experience conducting post-marketing safety studies of marketed medicinesExperience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authoritiesData analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology #LI-DM1#LI-RemoteJazz 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 ONLYJazz 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:$141,600.00 - $212,400.00Individual 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:SummaryLocation: Palo Alto, California; Carlsbad, California; Philadelphia, PennsylvaniaType: Full time