Manager, Serious Breach Office

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

Benefits offered by this job

Travel 10–15% (domestic & intl)

Job summary

Johnson & Johnson's Clinical Risk Management-Operational Excellence seeks a Manager of the Serious Breach Office to oversee serious breach reporting in clinical trials. The role emphasizes compliance, issue assessment, and process oversight with international stakeholder engagement.

The position requires a scientific or medical bachelor's degree and 1–3 years in healthcare, plus expertise in data visualization tools such as Tableau.

Qualifications

• Bachelor's degree in a scientific or medical field with 1–3 years of healthcare industry experience.
• Familiarity with clinical trial execution, GCP and regulatory requirements.
• Strong organizational and cross-functional influencing skills.

Responsibilities

• Facilitate assessment and reporting of significant quality issues in clinical trials.
• Develop and monitor process performance metrics and drive continual improvements.
• Lead cross-functional stakeholder collaboration and data-driven analysis.

Skills

Cross-functional collaboration

Facilitation

Data visualization

Tableau

Education

Bachelor's degree in a scientific or medical field

Tools

Tableau

Job description

Role

Manager of the Serious Breach Office within Johnson & Johnson's Clinical Risk Management-Operational Excellence team, focusing on compliance and oversight of serious breach reporting processes in clinical trials.

Responsibilities

Facilitate assessment and reporting of significant quality issues, develop and monitor process performance metrics, drive continual process improvements, analyze data with visualization tools, and lead cross-functional stakeholder collaboration.

Qualifications

Bachelor's degree in a scientific or medical field; 1-3 years of relevant experience in healthcare industry, with familiarity in clinical trial execution, GCP, and regulatory requirements; strong organizational, facilitation, and cross-functional influencing skills; proficiency in data visualization tools (e.g., Tableau).

High Value

Expertise in clinical trial risk management, serious breach reporting frameworks, ICH guidelines, and experience with global health authority interactions; travel approximately 10-15%, primarily domestic and international; based in North America or EMEA regions with preferred locations in New Jersey, Pennsylvania, or nearby.

Work Setup

Role involves international stakeholder engagement and is based in multiple US or EMEA locations.