Robert Hutchinson
Associate Director, Process & Personnel Qualification Management Expert, R & d Quality @Johnson & Johnson Innovative Medicine
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WORK HISTORY
Associate Director, Process & Personnel Qualification Management Expert, R & d Quality @Johnson & Johnson Innovative Medicine
Horsham, PA, US
Lead the end-to-end design, development, and issuance of controlled procedural documents and associated training for the J&J Innovative Medicine R&D clinical development organization.• Wrote new cross-organizational guideline outlining key considerations and establishing minimum requirements for the use of real-world data (RWD) in clinical studies to generate real-world evidence (RWE) intended to support a regulatory decision. Co-authored internal abstract about the new guideline that was recognized at the 2023 J&J Innovative Medicine Global RWE Summit.• Led design and development of a new process and associated SOP for the identification, analysis, assessment, and reporting of anticipated events in clinical trials. Process design included the planning and facilitation of a full-day summit with subject matter experts from Clinical, Safety, Statistics, Medical Writing, and Regulatory. Launched new process via an innovative multimedia training course that included a professionally recorded video introduction by the business process owner, animations, audio narration, and a learning assessment. Resulted in compliance with FDA safety reporting requirements and, for studies with protocol-identified anticipated events, a reduced number of individual case safety reports submitted in the US.• Supported the new Data Science & Digital Health department (app. 250 colleagues) in the identification of procedural documents applicable to their research activities and gaps where document revisions or new procedural documents were needed. Mapped departmental roles to procedural document roles, educated departmental representatives on the operational implementation and maintenance of role-based curricula, and determined the new role-specific curricula that were needed.
EDUCATION
Temple University - School of Pharmacy
MS, Quality Assurance/Regulatory Affairs
University of North Texas
MBA, Production/Operations Management
McDaniel College (formerly Western Maryland College)
BA, Biology (Chemistry minor)
SKILLS
ABOUT ROBERT HUTCHINSON
Results-driven quality and compliance professional with extensive pharmaceutical industry experience. Demonstrated proficiency in understanding complex regulatory/legal requirements and establishing clear policies, processes, and forms/templates that enable organizational compliance. Skilled in training curriculum development and maintenance.Expertise includes: Policy/SOP Development, Inspection Readiness, Learning Management Systems, Cross-Functional Team Leadership, GxPs and Regulatory Requirements, Quality Control/Quality Assurance, Root Cause Analysis/CAPA Management, Document Management
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