Manager, Serious Breach Office

Manager of the Serious Breach Office within Johnson & Johnson's Clinical Risk Management team, focusing on compliance, process oversight, and continuous improvement of serious breach reporting for JJIM-sponsored clinical trials. Responsibilities include facilitating breach assessments, ensuring timely and accurate reporting to health authorities, developing performance metrics, and leading process optimization initiatives. The role also involves data analysis, dashboard creation, stakeholder collaboration, and representing the SBO in strategic meetings. Requirements Bachelor's degree in a scientific or medical field 1-3 years of relevant experience in healthcare, pharma, medical devices, or biologics Knowledge of clinical trial risk management, GCP, and serious breach reporting guidelines (ICH) Skills Strong organizational, project management, stakeholder engagement, and communication abilities Proficiency in data visualization tools (e.g., Tableau, Spotfire) Preferred Qualifications Experience with clinical trial execution, document management, and compliance functions High-value specifics Focus on clinical trial compliance in a regulated biopharma environment International and domestic travel (~10-15%) Collaboration across functions and regions Locations Flexible locations in North America or EMEA regions, with a preference for sites in New Jersey or Pennsylvania. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine