Implementation Specialist

• Manage full lifecycle implementation projects — from requirements definition and scoping to validation, go-live, and post-deployment support — ensuring on-time, high-quality delivery.
• Apply deep understanding of regulated Life Sciences business processes, including regulatory submissions, labeling management, product registration, quality event handling, and device master record maintenance.
• Design and oversee integrations between LexisNexis solutions and customer enterprise systems such as RIMS, QMS, LIMS, PLM, ERP, and Supply Chain platforms, using APIs or middleware to ensure accurate and compliant data exchange.
• Lead validation strategy and execution, including requirements definition, risk assessments, and authoring/review of validation deliverables (URS, IQ/OQ/PQ).
• Ensure full traceability and adherence to regulatory standards (21 CFR Part 11, ISO 13485).
• Collaborate with client process owners to document and optimize end-to-end workflows that integrate regulatory, labeling, and quality data flows, ensuring efficiency, consistency, and compliance.
• Oversee the planning and delivery of customer training programs, including system onboarding, validation workshops, and best practice sessions for regulatory and quality teams.
• Act as the primary customer contact during implementation, managing expectations, risks, and communications across both client and LexisNexis teams.
• Contribute to the development of reusable implementation frameworks, validation templates, and integration patterns to accelerate future deployments and maintain consistency across clients.

Life Sciences Implementation Manager

Life Sciences Implementation Manager