Associate Director, Nonclinical Writing AI Innovation
Core
Lead strategy and adoption of AI-enabled capabilities to improve productivity and efficiencies in nonclinical regulatory writing workflows.
Role type
Associate Director, AI Innovation & Digital Transformation
Builds
Scalable digital solutions for nonclinical regulatory dossiers, reporting, and data integrity
Domain
Life Sciences / Regulatory Affairs / AI & Digital Transformation
Deliverable
production ML models | product features | dashboards & analysis
Required skills
AI strategy definition, cross-functional leadership, regulatory document authoring, AI tool implementation, ROI tracking, change management, vendor evaluation, GXP compliance
Preferred skills
Master's or PhD, enterprise AI tools experience, low-code prototyping
Technologies
LLM platforms, agentic AI, low-code prototyping tools
Responsibilities
Lead intake and prioritization of AI use cases; Partner with scientific, regulatory, and IT teams to deploy AI solutions; Author regulatory documents using AI tools; Define and execute AI strategy roadmap; Champion adoption of AI and automation; Evaluate emerging AI technologies; Establish best practices for responsible AI use; Build AI capability through training and coaching.