Senior Specialist, Clinical Risk Management

Senior Specialist in Clinical Risk Management at Johnson & Johnson. Manages risk identification, assessment, and mitigation across clinical trials; develops and maintains Clinical Quality Plans, supports CAPA development and effectiveness checks, and ensures inspection readiness.Collaborates with risk owners to evaluate mitigation actions, communicates risk updates through Quality Working Groups, and provides guidance on quality investigations. Brings data analytics and visualization skills (e.g., Tableau, Spotfire) to drive quality decisions, supports investigator, sponsor-monitor, and third-party inspections, and ensures alignment with international regulations (ICH, FDA/EMA) and corporate quality standards. Requires a Bachelor’s degree and at least 6 years in healthcare/pharma, strong communication and cross-functional collaboration abilities, and willingness to travel up to 10%. This role is located across multiple U.S. offices (Horsham, Spring House, Titusville, Raritan) with hybrid intra-organizational coordination as needed.