About the Role

We are seeking experienced Domain Subject Matter Experts (SMEs) to support AI-powered initiatives across Clinical Operations, Safety, Regulatory, and Medical Affairs. The Domain SME will bridge the gap between clinical development business processes and AWS AI/ML technical delivery, providing critical domain context during the discovery, scoping, and validation of AI use cases.

Key Responsibilities
Participate in discovery workshops with business stakeholders to validate problem statements, current processes, and desired outcomes
Provide pharmaceutical clinical development domain expertise to guide AI use case scoping and feasibility assessment
Translate complex business requirements into structured inputs for AI/ML engineering teams
Support T-shirt sizing (S/M/L) of use cases with domain-informed effort estimates
Validate AI-generated prototypes and POC outputs against business process reality
Contribute to Working Backwards sessions, ensuring customer outcomes remain central to solution design
Support the creation of project charters, user personas,



and journey maps
Collaborate with AWS Data Scientists and App Architects in multi-disciplinary squads

Requirements
5+ years in pharmaceutical clinical development, clinical operations, pharmacovigilance, regulatory affairs, or medical affairs
Deep understanding of drug development lifecycle, GxP-regulated processes, and specific systems (Veeva, NGDP, SPINE, FREEWAY preferred)
Experience working as a business analyst, product owner, or domain SME on digital transformation or AI/ML programmes in life sciences
Solid workshop facilitation and stakeholder engagement skills
Ability to translate between business language and technical requirements

Nice to Have
Prior experience with large pharma enterprises.
Familiarity with AI/ML concepts, GenAI, and agentic workflows
Experience with Agile/Scrum delivery in regulated settings
Understanding of ICH guidelines, FDA/EMA regulatory frameworks

📌 Domain Sme Pharmaceutical & Clinical Development Hyderabad
🏢 Space Inventive
📍 Hyderabad