J&J Family of Companies Director, Epidemiology and Real-World Data Sciences, Medical Devices in United States
Director, Epidemiology and Real-World Data Sciences, Medical Devices
The Medical Device Epidemiology and Real-World Data Science (Epi-RWDS) organization in Johnson & Johnson (J&J) group is located in the New Brunswick, NJ office. We are recruiting for an exciting opportunity as Director, Safety Epidemiology and Real-World Data Sciences position located in one of the following J&J offices: New Brunswick, NJ, Titusville NJ, West Chester PA, Raynham, MA, Warsaw, IN, Cincinnati, OH, or remote. You will visit our team headquarters in the New Brunswick, NJ office at least once a year.
Caring for the world, one person at a time inspires and unites the people of J&J. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the J&J Family of Companies work with partners in health care to touch the lives of over a billion people every single day, throughout the world. We thrive on and grow with a diverse company culture, celebrate the uniqueness of our employees, are committed to inclusion, follow the ethics-based Credo of J&J, and are proud to be an equal opportunity employer.
Our Epi-RWDS organization in J&J conducts observational research to support product development, product launch, post-market safety and effectiveness, value assessments, and business development of medical devices. The team leads RWD innovation and methodological excellence across J&J’s medical device sector. The team provides skills in using real-world evidence to answer questions related to safety, product development, label extensions, value demonstration for payers, and other activities.
The Director will perform the following for the Medical Device sector:
You will independently design and execute post-marketing safety studies to meet regulatory requirements, particularly the European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance,
You will leverage epidemiology methods to address emerging safety signals and queries from regulatory authorities
You will develop new safety surveillance methods in collaboration with J&J teammates and in consultation with EU regulatory competent authorities and the FDA
You will partner with other groups at J&J to lead and execute epidemiologic studies using real world data to assess safety. A priority focus is on RWE surveillance studies to meet EU-MDR requirements using claims, electronic medical records, registries, and spontaneously reported complaints data.
You will lead initiatives and epidemiology trainings, as needed
You will communicate with and lead projects with regulatory agencies, such as the US Food and Drug Administration (FDA), Notifying Bodies in the EU and the Chinese FDA.
You will write study protocols, use a variety of analytical techniques applied to various databases, and strategize regarding research programs.
You will collaborate with academic institutions, health systems, registries and other research partners on research methods, infrastructure development, scientific advocacy and advance benefit-risk assessment for medical devices.
You will participate in various activities of medical device businesses (DePuy Synthes, Ethicon, and Cardiovascular and Specialty Solutions), the larger cross-sector Epidemiology Department (Janssen Pharmaceutical and J&J Consumer) and the Office of Chief Medical Officer.
The position requires maturity and astute judgement in interpreting observational data to support regulatory decisions regarding device safety. You will report to the Senior Director for Safety, Epi-RWDS, who reports to the Vice President of Epi-RWDS, who reports to the Senior Vice President of Epidemiology for all J&J sectors in the Office of the Chief Medical Officer.
A PhD or MD in the same areas with at least 8 years of Epidemiology or related research work experience is required. Alternatively, a Master’s degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, or other related field with at least 10 years of Epidemiology or related research work experience is required.
Epidemiology or related research work experience in Industry is preferred
Experience in designing and conducting safety studies is preferred
Experience in a statistical programming language (e.g. SAS, R, SQL) is preferred
In-depth knowledge of healthcare databases, registries, observational study design is required
Experience with medical devices is preferred
Experience with adverse event report/complaints signal detection and analysis is preferred
A sophisticated understanding and ability to analyze and interpret quantitative data is required
Experience writing methods sections of study proposals and protocols is required
Experience authoring peer reviewed publications using RWD is required
Experience in cross-functional collaboration and working in matrix teams is required
Experience working with regulatory authorities and/or European notified bodies is preferred
This position may require up to 25% domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.
United States-New Jersey-New Brunswick-One Johnson & Johnson Plaza
North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Titusville, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States
Medical Devices & Diagnostics Global Services, LLC (6209)
J&J Family of Companies
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