About this opportunity
Jazz Pharmaceuticals lists this Senior Manager, Epidemiology opportunity in workfromhome, Missouri. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
Present research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals.
Ensure compliance with all applicable laws, regulations and regulatory guidelines
Required Knowledge, Skills, and Abilities
Advanced 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 academia
Experience with rare disease studies
Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
Experience successfully coordinating cross-functional processes
Experience analyzing secondary data sources (administrative claims and EMR databases)
Excellent oral and written communication skills in English
Solid understanding of epidemiology and biostatistics
Experience managing multiple projects and reprioritizing work when necessary
Capable of working remotely with minimal supervision
Proficiency with MS Word, Excel and PowerPoint
Ability to travel approximately 10% time
Required/Preferred Education and Licenses
Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
Experience conducting post-marketing safety studies of marketed medicines
Experience 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 authorities
Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology
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Worksite address
workfromhome, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.