Manager, Serious Breach Office

Role: Manager of the Serious Breach Office within Johnson & Johnson's Clinical Risk Management-Operational Excellence team, primarily responsible for ensuring compliance with serious breach reporting requirements across global clinical trials. Responsibilities include facilitating breach assessments, driving process oversight, developing performance metrics, and leading process improvement initiatives. The role involves collaboration with cross-functional teams, stakeholder engagement, and data analysis to monitor reporting effectiveness and compliance. Qualifications: Bachelor's degree in a scientific or medical discipline; 1-3 years of relevant healthcare or pharmaceutical industry experience, including clinical trial or GCP familiarity; strong organizational, project management, and communication skills; proficiency in data visualization tools (e.g., Tableau, Spotfire) preferred. High-value specifics include experience with clinical trial risk management, serious breach reporting standards, and GCP guidelines, with international travel (~10-15%). Located in North America or EMEA, with preferred sites in New Jersey, Pennsylvania, or the UK.