Associate Director

The Johnson & Johnson MedTech Epidemiology and Real-World Data Science team is recruiting for an Associate Director, Epidemiology & Real-World Data Science . The primary and preferred locations for this position is Titusville, NJ. Consideration may also be given for this position to be located in New Brunswick, NJ, West Chester PA, Raynham, MA, Cincinnati, OH, or Horsham, PA. Remote work options in the US may be considered on a case-by-case basis and if approved by the Company. The position reports to a Senior Director of MedTech Epidemiology & Real-World Data Sciences within the cross-sector Global Epidemiology Organization and the Office of the Chief Medical Officer. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Johnson & Johnson MedTech Companies have been working to benefit patients by improving surgery for over a century. The MedTech Epidemiology and Real-World Data Science team is an industry leader in using real world evidence for medical devices and technologies. We are driven by J&J's Credo to benefit the patients we serve of all races, ethnicities, genders, and sexual orientation, to care for our employees, to benefit the communities and environment we work in and to work for the success our shareholders. Our goal is to apply RWE as a tool to efficiently address the needs of J&J's MedTech sector and to benefit patients. To do this, we focus in 5 areas: 1) evidence for market access and adoption globally, 2) evaluations of product safety, 3) evidence for regulatory approvals (pre- and post-approval), 4) advancing the use of AI/ML use for MedTech, and 5) evidence for business development due diligence and identification of unmet needs. This position is an exciting opportunity to lead safety-focused real-world data studies to support the generation of clinical evidence for post-market clinical follow-up activities to meet regulatory requirements, patient safety, and post-market surveillance. The position requires good judgement in interpreting observational data to support regulatory decisions regarding patient safety. Key Responsibilities: You will actively partner with the Medical Safety, Medical Affairs, Scientific and Clinical Affairs, and R&D. You will lead the design and conduct of epidemiologic studies using real world data to assess patient safety. A priority focus is on RWE studies to meet regulatory requirements, particularly European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance. You will write study protocols and study reports, use a variety of analytical techniques applied to various databases, and strategize regarding research programs. You will leverage epidemiology methods to address emerging safety signals and queries. You will assist in developing new safety surveillance methods in collaboration with J&J teammates. You will communicate with and lead projects with regulatory agencies, such as the US Food and Drug Administration (FDA) and Notified Bodies in the EU. 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.