Manager, Serious Breach Office

Role: Manager of the Serious Breach Office within Johnson & Johnson's Clinical Risk Management-Operational Excellence team, focusing on compliance and oversight of serious breach reporting processes in clinical trials. Responsibilities: facilitate assessment and reporting of significant quality issues, develop and monitor process performance metrics, drive continual process improvements, analyze data with visualization tools, and lead cross-functional stakeholder collaboration. Qualifications: Bachelor's degree in a scientific or medical field; 1-3 years of relevant experience in healthcare industry, with familiarity in clinical trial execution, GCP, and regulatory requirements; strong organizational, facilitation, and cross-functional influencing skills; proficiency in data visualization tools (e.g., Tableau). HighValue: expertise in clinical trial risk management, serious breach reporting frameworks, ICH guidelines, and experience with global health authority interactions; travel approximately 10-15%, primarily domestic and international; based in North America or EMEA regions with preferred locations in New Jersey, Pennsylvania, or nearby. WorkSetup: role involves international stakeholder engagement and is based in multiple US or EMEA locations.