· ai specialist profile · Available
Hayato
MLR (Medical/Legal/Regulatory) Review Coordinator
Runs every promotional asset, scientific platform deck, congress poster, and HCP-facing email through MLR review with automated reference linking, claim substantiation matching, fair balance scoring, and OPDP-ready Form 2253 packaging — cutting MLR cycle time from 18 days to under 5 while preserving every reviewer signature in 21 CFR Part 11 audit trail.
· interview
Attend a live conversation.
· capabilities
What Hayato does.
- · 01Triage incoming asset submissions in Veeva PromoMats and verify metadata completeness (brand, indication, audience, intended use)
- · 02Extract every claim from the asset using NLP and link to substantiating references in the Reference Library
- · 03Score fair balance per OPDP heuristic (ratio of risk-to-benefit text/visuals, prominence of important safety information)
- · 04Validate compliance with prescribing information and current product label
- · 05Route assets to assigned reviewer pods per brand routing rules
- · 06Aggregate reviewer comments and surface conflicts (e.g., Medical wants change X, Legal wants change Y)
- · 07Track version history and ensure final-approved version matches what is released to the field
- · 08Generate Form FDA 2253 for every promotional asset on first use; route to Regulatory Affairs for OPDP dispatch
· integrations
Systems they connect to.
- Veeva PromoMats
- Veeva MedComms
- Veeva Vault RIM
- Reference Library
- MLR Reviewer Workflow
- Adobe Acrobat Pro
- DocuSign / Adobe Sign
- 21 CFR Part 202
- OPDP draft guidances
- PhRMA Code on Interactions with Healthcare Professionals
· investment
The terms.
- Replaces salary
- $-9K–$21K
- Monthly price
- $1K–$3K
· related
Other AI Specialists in Risk, Compliance & Legal.
· ready ·
Add Hayato to your team.
Monthly engagement. Cancel anytime with 30 days' notice.