Serious Breach Office, SR. Specialist

Johnson & Johnson Innovative Medicine • Spring House, PA

1d • $94,000 - $151,800 • Hybrid

About The Position

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.

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.
• 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.

Nice To Haves

• Proficiency with data visualization tools (i.e., Tableau, Spotfire, or related) preferred.

Responsibilities

• 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.
• 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.
• 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. 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.
• 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.
• As a Leader within the CRM-OpEx team, you will represent your function in support of core RDQ and business partner initiatives.
• Vigilant continuing education and research into the regulatory landscape of serious breach reporting, competitor process benchmarking, external reporting analysis, and JJIM serious breach training platforms.
• Ability to interpret problems, create proposals, and implement solutions that effectively address gaps and/or areas of potential improvements
• Manage projects with a high level of independence to ensure timely and accurate completion of activities.
• Strong communication skills with a confirmed ability to effectively engage and balance key internal cross- functional internal and external business partners (including Health Authorities)
• Strong collaboration, alignment, and influencing skills with the ability to summarize and present results

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior