Manager, Serious Breach Office

Role: Manager in the Serious Breach Office within Johnson & Johnson's Clinical Risk Management team, focusing on compliance and process oversight for serious breach reporting in clinical trials. Responsibilities include facilitating and monitoring breach assessments, driving process improvements, developing performance metrics, and ensuring timely reporting to health authorities. The role involves cross-functional collaboration with R&D, legal, quality, and external stakeholders, as well as data analysis and visualization to support decision-making. Qualifications: Bachelor's degree in a scientific or medical field; 1-3 years of experience in healthcare or biopharma industries, with knowledge of clinical trial processes, GCP, and regulatory reporting requirements. Skills include project management, stakeholder engagement, data analysis, and proficiency with visualization tools such as Tableau. High-value details: Focus on clinical trial compliance, serious breach reporting, and risk management; experience with ICH guidelines; global/regional regulatory knowledge; travel (~10-15%) primarily domestic and international; located in North America or EMEA regions, with preference for specific US sites.