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 environments

- Understanding of ICH guidelines, FDA/EMA regulatory frameworks

📌 Domain SME - Pharmaceutical & Clinical Development (Hyderabad)
🏢 Space Inventive
📍 Hyderabad