Indegene AI Solutions Strategist — Round 1 Cheat Sheet (Front)

Company Facts

• Indegene: NSE-listed life sciences commercialization company, ~27 years therapeutic/regulatory expertise, "AI Decade" growth narrative.
• FY26 (ended Mar 2026): revenue INR 35,105M (23.6% YoY); active clients 73→91; $1M+ clients 41→53; 17% YoY higher FY27 pipeline aided by "new solution traction" incl. Medical Writing.
• Platform chain: Cortex (Feb 2025, LLM-agnostic multi-agent GenAI platform) → NEXT Medical Writing Automation (Jul 2025, built on Cortex, Word-embedded, RIM-integrated) → seeded by Trilogy Writing & Consulting acquisition (Mar 27, 2024).
• Cloud: Microsoft (Azure OpenAI, Copilot, Fabric – Jul 2024 partnership) + AWS (CloudWatch hosting for NEXT).
• Sameer Lal, SVP Enterprise Medical Solutions (since 2015) – owns this function; quoted at NEXT's launch.
• Analyst validation: HFS Horizons "Exponential Leader"; Everest Group PEAK Matrix "Leader."
• This role is NOT on Indegene's own careers site under this title – likely Mapout/Zodiac's own title construction for a staffing engagement against an existing NEXT/Medical Writing program.

Top 15 Predicted Questions

1. Walk us through a time you kept an evidence narrative consistent across multiple regulatory documents.
   → Amgen: CTD Module 3–5, GenAI-to-SCA loop under GxP change control.
2. How do you evaluate whether an AI-generated output is source-grounded and defensible?
   → NewsRx: 4-judge blind eval vs. HHEM/BERTScore, ALCOA+ audit trail.
3. Describe your experience configuring or governing an AI content platform – template architecture, output rules, quality frameworks.
   → NewsRx: one config change, four audience outputs.
4. Where have you seen AI drafting tools fail, and how did you catch it?
   → NewsRx: a summary called pregnancy outcomes "safe" when one of three women in the study died. Caught by the QA persona layer, missed by automated scoring.
5. How do you establish human-in-the-loop review standards for AI-generated regulated content?
   → NewsRx: 4-layer QA, human sign-off gate, 21 CFR Part 11 e-signatures.
6. Describe a time you diagnosed a client's failure mode before proposing a solution.
   → Cardinal Health: root-caused data quality before recovering $300M in claims.
7. How do you translate technical/regulatory capability into a recommendation a non-technical stakeholder can act on?
   → Amgen: translated architecture into a Board-approved scope expansion.
8. What's your experience with ICH, FDA, or other regulatory writing standards?
   → 42 years RPh/RNPh under NRC/FDA; Amgen ICH/CTD FDA NDA work directly.
9. You don't have a traditional "medical writer" title – how do you address that given this role wants 10–15 years of medical writing experience?
   → IND for radiolabeled WBC human injection (pharmacy school) + Amgen output validation. Not zero, just not a title.
10. Tell me about your experience working directly with clinical or regulatory writers.
    → Amgen: worked directly with CMC clinical writers producing the CTD content itself.
11. How comfortable are you with a Global Working Model and frequent client-site travel?
    → Amgen: GA-based, coordinated with the client in CA and the Bain team in Australia, three time zones at once. J&J MedTech: GA-based, coordinated with teams in NJ and Ireland plus full-EU SME input and sign-offs. A lifetime of this, not a new ask.
12. What do you know about Indegene's AI platform strategy?
    → Cortex (Feb 2025) → NEXT (Jul 2025), seeded by the Trilogy acquisition. Adoption is the real gap, not the platform.
13. Why this role, specifically, at the intersection of medical writing and AI governance?
    → 42 years of regulatory practice plus hands-on AI governance. This role needs both at once.
14. How do you handle ambiguity when working directly with senior client stakeholders?
    → Evernorth: resolved conflicting executive interpretations across 147 CMS reports.
15. Tell us about a time your AI system caught a content quality issue that automated checks missed.
    → NewsRx: a summary called an outcome "safe" when one of three patients died. Automated scoring missed it; the blinded judge layer caught it.

"Tell Me About Yourself" – Flow (60–90 sec, 5 beats)

1. Foundation: 42 years licensed RPh/RNPh under NRC/FDA. The regulatory discipline is the root, not a side credential.
2. The arc: decades of regulated data and systems work built on that foundation – Cardinal Health, J&J MedTech – then AI specifically once the tools caught up to the discipline.
3. The proof point: Amgen – built the first GxP-validated GenAI system for an FDA NDA, ICH CTD content, human sign-off preserved throughout.
4. The current work: NewsRx, now – run and govern a production agentic writing system, 88% reviewer preference over originals.
5. The bridge: this role needs that exact combination – regulatory depth plus AI governance, not one without the other. That's what brought me here.