Senior Manager, Epidemiology
About the role
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.
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