Global Serious Breach Reporting Lead

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

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.