Manager, Serious Breach Office

Scorpion Therapeutics; New Brunswick (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Manager of the Serious Breach Office within Clinical Risk Management-Operational Excellence. You will ensure adherence to serious breach reporting across global clinical trials and drive continuous improvement in risk management processes.

Responsibilities include coordinating breach assessments, developing metrics, and partnering with cross-functional teams. Travel ~10-15% and involvement with GCP guidelines are expected.

Qualifications

• Bachelor's degree in a scientific or medical discipline.
• 1–3 years of healthcare or pharma industry experience, including clinical trials or GCP.
• Experience with clinical trial risk management, serious breach reporting standards, and GCP guidelines.

Responsibilities

• Facilitate breach assessments and drive process oversight.
• Develop performance metrics and lead process improvement initiatives.
• Collaborate with cross-functional teams and analyze data to monitor reporting compliance.

Skills

Data visualization

Project management

Communication skills

Education

Bachelor's degree in scientific/medical discipline

Tools

Tableau

Spotfire

Job description

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

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.