About this role
Lead strategy and adoption of AI-enabled capabilities across nonclinical workflows to improve productivity, data quality, and authoring of regulatory documents. Partner cross-functionally to identify use cases, operationalize AI tools (including LLMs and agentic AI), and establish responsible, compliant AI practices.
Skills for this role
AI strategyAI tool automationRegulatory writingNonclinical writingAuthoring regulatory dossiersLLM platformsAgentic AI conceptsLow-code prototypingHuman-in-the-loop deploymentAI governance frameworksData integrityGxP complianceeCTD submissionsSEND (Standard for Exchange of Nonclinical Data)Vendor managementCloud platformsData architectureProgram managementCross-functional collaborationChange managementTraining and coachingQuality controlInformation security (InfoSec)