Judith J. Email and Phone Number

Supported operations of business systems (e.g. Calyx Insight RIM) established for Regulatory. Shared accountability for ensuring regulatory systems were fully supporting all phases of product registration and lifecycle management for Organon products. Collaborated with stakeholders and users of the regulatory capabilities to plan and execute operational business system activities.• As part of Organon spinoff from Merck, led manual migration activities between global Health Registration Management (RIM) systems among internal customers and external contractors. Supported coordinated efforts to ensure quality control of datasets.• Teamed with functional area contacts, process owners and IT product/account managers to align tools, systems, and procedures with business process and information needs. • Harmonized current and future Organon Health Registration Management training requirements/matrices, identifying needed educational materials• Coordinated continued implementation of Organon HRM Data Quality Initiative and related Dashboard to address data discrepancies in Organon RIM system

• Leadership-appointed advancements included in 2021 to peer coaching group and in 2020 as part of new Escalations Team. Results included significant reduction in issues that needed further leadership resolution over 2020-2021.• Collaborated with team members across departments/brands (Williams-Sonoma, Inc., Pottery Barn, pottery barn kids, PBteen, and West Elm), as well as third parties where applicable, to research and resolve issues.

• Master Certificate and Certified Professional in Business Intelligence (CPBI), 2015• Certified Information Professional (CIP) 2012, re-certifications in 2016 and 2018• Ongoing professional memberships and learning (AIIM, ARMA)• Core skill enhancement; time management, problem solving, decision-making, flexibility, volunteerism.

• Developed and implemented architecture for Solvay Pharmaceuticals Inc.'s first GxP regulatory content support group; Non-clinical, Clinical, Regulatory, CMC, QA and IT. • Analyzed related processes, workflows and SOPs/internal standards through document analysis and interviews. Translated business requirements into updated, streamlined versions for use.• Coordinated global group functional support for internal and external health agency inspection/audit (e.g. FDA, EMEA).• Overhauled job descriptions to align with industry standards.• Coordinated management of extensive onsite contractors/vendors and off-site storage vendor.• Business owner for Solvay Pharmaceuticals, Inc.'s regulatory information inventory system.• Translated global stakeholder requirements into tangible, harmonized procedural documents via partnerships with all Solvay Pharmaceuticals sites (France, Germany, Netherlands).• Spearheaded company's first Global Information Management Intelligence Team for regulation, guidance, and industry standard analysis (e.g. ARMA/AIIM, FDA (GMP, GLP, GCP, ISO, EMEA).• Created first corporate records management strategy via liaisons with key stakeholders and C-Level leadership across business segments; e.g. Finance, IT, Legal, Regulatory, Quality, Operations, Development, Human Resources and Marketing.• Collaborated across all Solvay North America, Inc. sectors (Chemicals, Plastics, Pharmaceuticals) to create company’s first multi-sectored records retention schedule.• Directed departmental activities, many concurrently, supporting multi-million dollar corporate initiatives; Acquisition Research and Information Integration, Divestiture Research and Information Transfer, and Litigation Discovery• As part of $6.2B acquisition of Solvay Pharmaceuticals by Abbott Laboratories and company closure, coordinated transfer of all U.S. records management informational assets to parent company.