Principal Scientist | RWE & Surveillance

Job description

Lead post-market surveillance, epidemiological and real-world evidence (RWE) research on the individual and population health impact of smoke-free nicotine products for a Fortune 500 company with some of the most iconic brands! Have a PhD with eight years of relevant experience in behavioral science, public health, population health, RWE, epidemiology, and/or analysis of large databases? If so, we want to speak with you!

We are actively recruiting for a Principal Scientist | RWE & Surveillance to join our Behavior & Health Sciences group. The position is based in Richmond, VA with a hybrid work schedule, although remote work arrangements can be considered. Relocation assistance is available for candidates who relocate to Richmond. The successful candidate will help shape and deliver ongoing monitoring of the tobacco and nicotine marketplace and post-market surveillance of marketed smoke-free products, assessing their individual and population health impact to meet FDA post-market obligations, generate rigorous epidemiological and RWE insights, and translate findings into scientific content for regulatory submissions and external engagement.

What you will be doing

Shape and execute the overall post-market surveillance strategy for authorized products (e.g., PMTA and MRTP marketing orders), integrating multiple evidence streams

• Design, execute, and oversee Post-Market Surveillance Studies (PMSS) required under marketing orders, including protocols, statistical analysis plans and study reports
• Prepare and manage periodic post-market reports to FDA, integrating PMSS results and other surveillance data, ensuring accuracy and timely delivery Anticipate evolving FDA post-market expectations and continuously improve post-market surveillance processes, SOPs and data governance
• Monitor, critically evaluate and synthesize epidemiological and RWE literature to inform study design and evidence strategy
• Translate research findings into FDA responses, regulatory-submission content, conference presentations, and peer-reviewed publications.

Collaborate with regulatory affairs, product stewardship, behavioral research, biostatistics, and internal and external researchers while managing multiple priorities and deadlines.

We want you to have: PhD in epidemiology or a related field such as behavioral science, public health or data science

• 8+ years of relevant experience in behavioral science, public health, population health, RWE, epidemiology, and/or analysis of large databases
• Demonstrated experience and ability to design and conduct epidemiological and RWE studies Experience in post-market surveillance, pharmacovigilance, or /surveillance studies
• Strong analytical and statistical skills (SAS, R, SPSS or Stata) and accuracy with large volumes of data
• Ability to solve complex problems using advanced quantitative methods
• Strong verbal and written communication skills to effectively share findings with others
• Ability to work independently and collaborate as a member of cross-functional teams