Serious Breach Office, SR. Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Johnson & Johnson is currently recruiting for a Serious Breach Office (SBO), Sr. Specialist! This position can be located in Spring House, PA, Raritan, NJ or Beerse, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-077617
EMEA– Requisition# R-

Position Summary:

The Serious Breach Office (SBO), Sr. Specialist is a member of the Clinical Risk Management-Operational Excellence (CRM-OpEx) function of R&D Quality (RDQ). This role provides JJIM awareness, facilitation and alignment of the processes that enable compliance to the country and regional level serious breach reporting requirements for JJIM sponsored clinical trials.

The incumbent will drive accountability in the implementation of the RDQ serious breach reporting process under the guidance of the SBO management and in collaboration with contributing business partners. Through the coordination and consultation of stakeholder business partners, the SBO, Sr. Specialist will facilitate the assessment of significant quality issues related to JJIM sponsored clinical trials for reportability to serious breach reporting countries and/or regions.

Main Responsibilities:

·        Serious Breach Office (SBO): As a facilitator of the serious breach process and record owner, you will drive the assessments and reporting of issues or events related to JJIM clinical trials that meet the serious breach reporting criteria to the appropriate corresponding Health Authorities. You will be a member of a team designated as the primary subject matter experts for the JJIM organization to ensure compliance, effectiveness, and continual improvement of the serious breach reporting and detection processes.

·        Serious Breach Process Facilitator: As a designated SBO Lead, you will define, drive and enhance oversight strategies and monitoring capabilities to ensure the effectiveness and compliance elements of the serious breach process within clinical trial risk and issue management framework. You will facilitate early consultation and timely assessment activities across stakeholder organizations and varying levels of JJIM leadership to ensure the appropriate dispositioning of potential serious breaches related to JJIM clinical trials.

·        Process Performance Monitoring: You will develop, assess and report performance metrics related to quality, efficiency, and risk for serious breach process execution and timely case reporting identifying process and/or compliance strengths and gaps for management review.

·        Continual Improvement Driver: As a steward of continual process improvement, you will monitor adherence to implemented process controls, effectiveness and risk management requirements in alignment with associated business partner processes, enterprise standards and industry regulations to develop proposals for optimization initiatives.  You will identify and deliver key improvements to the serious breach process in collaboration with CRM, and key business partners-RDQA, GD, Legal, JJIMQ, and GRA.

·        Data Analysis and Visualization: As a presenter and primary monitor of serious breach reporting process effectiveness, you will collaborate with stakeholders to create and moni