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Director, Regulatory Real-World Evidence and Epidemiology
Requisition ID: 7416180320
The Johnson & Johnson Epidemiology and Health Informatics – Medical Devices (MD EPI) group is recruiting for a Director, Regulatory Real-World Evidence and Epidemiology position to be located in New Brunswick, NJ.
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Medical Device (MD) Epidemiology organization conducts observational research to support product development, product launch, post-market safety and effectiveness, value assessments, and business development of MD products. The team fosters methodological excellence across Johnson and Johnson’s medical device sector. The team provides analytical capabilities using large patient-level claims and electronic health record databases, spontaneous complaints and adverse event report databases and data from medical devices during procedures to answer a variety of questions related to safety, product development, label extensions, health economics and outcomes research, and other activities. The studies conducted by the MD Epidemiology group focus on safety, product development, health economic, market access, and label change topics. Safety topics include safety surveillance, evaluation of safety signals, device use patterns, predictive analytics of adverse outcomes from procedures, changes in label warnings and indications for use, benefit-risk assessment, and disease burden/progression/risk factors. Health economic and market access related topics include cost of disease and procedures, reimbursement patterns, market size, clinical standard of care, and comparative effectiveness research.
The Director will partner with stakeholders to design and conduct epidemiologic studies for purposes of submission to regulatory agencies, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory authority bodies. These studies may focus on label extensions, proactive safety surveillance, and utilization pattern studies. The candidate will be required to write study protocols, use a variety of analytical techniques applied to various databases, and strategize regarding research programs. The Director will proactively lead engagement with external partners associated with the FDA and EMA, eg, MDEpiNet, NEST, MDIC, academic institutions, health systems, to help advance the current thinking and infrastructure of research methods for generating real world evidence to support regulatory decisions through various innovative initiatives and projects.
The role will involve leadership and/or participation in various project teams and task forces in addressing issues raised by product teams or regulatory agencies, where it will provide epidemiologic consulting to product teams, design and conduct epidemiologic or health outcomes studies, generate needed real world evidence, and/or disseminate scientific information through technical reports, presentations, and publications in peer-reviewed literature, as agreed by the team.
- Connect and partner with FDA and other regulatory agencies, external health information technology and data vendors, Integrated Delivery Networks, academic research centers, registries, industry groups, government bodies, etc. to access/develop novel healthcare data and research methodologies.
- Lead or participate in various work streams/ task forces to evaluate the real world data environment with a regulatory perspective and assessing and/or communicating its implications for the MD sector
- Manage/direct a portfolio of projects, drafting protocols, and leading the statistical analysis of healthcare database studies (insurance claims data, hospital billing data, electronic medical records, registries, etc.) to support safety surveillance, and regulatory requirements, in close collaboration with the analytics team within MD Epidemiology and the Regulatory groups.
- Participate in various activities of the larger Epidemiology Department (Janssen Pharmaceutical and Johnson and Johnson Consumer) and the Office of Chief Medical Officer
- A minimum of a Master’s Degree (or equivalent) in epidemiology, health services research, health outcomes research, biostatistics, or other related field is required; a PhD would be highly preferred
- A minimum of 10 years of epidemiology or related research work experience in healthcare is required; If the individual has a PhD, a minimum of 7 years’ experience in epidemiology or related research work experience in healthcare is required
- Experience working in Medical Device research is preferred
- In-depth knowledge of healthcare databases, registries, observational study design, and related analytical methodology is required
- A sophisticated understanding and ability to analyze and interpret quantitative data is required
- Experience with writing methods sections of study proposals/ protocols/ proposal requests or background epidemiologic material on specific disease or therapeutic areas is required
- Prior experience working with national regulatory authorities, such as the FDA and European Medicines Agency is preferred
- Experience authoring peer reviewed publications using real world datasets is preferred
- Experience in cross-functional partnering and working in matrix teams is preferred
- This position will require up to 15% of domestic and international travel
United States-New Jersey-New Brunswick
North America-United States
MD&D Global Services LLC (6209)