Manager, Serious Breach Office

Role: 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 include strong organizational, project management, stakeholder engagement, and communication abilities, with proficiency in data visualization tools (e.g., Tableau, Spotfire). Preferred qualifications include 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%), and collaboration across functions and regions. The position offers flexible locations in North America or EMEA regions, with a preference for sites in New Jersey or Pennsylvania.