Serious Breach Office, Senior Specialist

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. 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 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. 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. As a presenter and primary monitor of serious breach reporting process effectiveness, you will collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making. As a representative of the Serious Breach Office during process, strategic, and/or data reviews, you will model the appropriate level of preparedness, executive presence, confidence and assertiveness to thoroughly to enable efficient, data-driven decisions and actions. As part of the RDQ and broader J&J community, you will partner with JJIMQ Digital and Data Analytics, R&D stakeholders and other potential sources of benefit from across IM and MedTech to develop templates, scorecards, and dashboards that simplify activities for functional teams and contributors. You will represent your function in support of core RDQ and business partner initiatives. Requirements A minimum of a Bachelors or equivalent University degree is required with a focus in scientific, medical or related discipline preferred. A minimum of 1-3 years of relevant experience working in the health care industry pharmaceutical, medical device, Biologics company and/or Health Authority experience. Experience in clinical trial execution at a sponsor, investigational site or CRO, clinical trial document management, and/or GCP compliance functions preferred. Strong organizational and project management skills. Strong meeting facilitation skills. Experience leading and influencing complex, cross-functional teams. Previous experience with fundamentals of clinical trial risk management, serious breach reporting requirements, and corresponding ICH guidelines. Proficiency with data visualization tools (i.e., Tableau, Spotfire, or related) preferred. Ability to collect, analyze, interpret and present collective data to enable data-driven decision making. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Proficient in Microsoft Office Applications. Core Competencies Demonstrates expertise in clinical trial execution, serious breach reporting, and compliance with ICH guidelines, while effectively utilizing data visualization tools to drive data-driven decision making. Strong organizational, project management, and meeting facilitation skills are essential for optimizing processes and collaborating with cross-functional teams. Highest-signal resume keywords Clinical Trial Execution Serious Breach Reporting Data Visualization Tools Project Management GCP Compliance ATS Optimization Keywords Hard Skills Clinical Trial Document Management Risk Management Data Analysis Performance Metrics Development Process Improvement Soft Skills Organizational Skills Meeting Facilitation Interpersonal Communication Attention to Detail Executive Presence Industry Keywords Health Care Industry Pharmaceutical Medical Device Biologics Health Authority Tools & Technologies Tableau Spotfire Microsoft Office Applications #J-18808-Ljbffr Jobtailor