Manager, Serious Breach Office (MedTech)

Location: Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; or Issy-les-Moulineaux, France. The position may also be located in North America or other EMEA locations, with a preference for Raritan, Titusville, or New Brunswick, New Jersey, and Horsham, Pennsylvania. Travel of approximately 10–15% is required.

Base pay range: €79,800–€137,770 annually.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of prevention, treatment, and care.

What you will do

• Facilitate assessments and reporting of serious breaches related to sponsored clinical trials to the appropriate Health Authorities.
• Drive oversight strategies, monitoring capabilities, and timely consultation within the serious breach process.
• Develop and report quality, efficiency, and risk metrics for management review.
• Identify and implement process improvements aligned with business partner processes, enterprise standards, and industry regulations.
• Collaborate with stakeholders to create dashboards, templates, and scorecards for data-driven decision-making.
• Lead serious breach meetings and represent the function in cross-functional strategic initiatives.

Requirements

• Bachelor's degree in a scientific, medical, or related discipline.
• 1–3 years of relevant healthcare industry experience, including pharmaceutical, medical device, biologics, or Health Authority experience.
• Experience with clinical trial risk management, serious breach reporting requirements, and relevant ICH guidelines.
• Strong project management, meeting facilitation, communication, collaboration, and influencing skills.
• Ability to collect, analyze, interpret, and present data for data-driven decisions.
• Proficiency in Microsoft Office Applications; experience with Tableau, Spotfire, or related data visualization tools is preferred.

Culture & Benefits

• Inclusive work environment focused on respect, diversity, dignity, and employee recognition.
• Annual bonus based on pay grade, location, and performance.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans subject to applicable plan terms and location.