Morrisville, North Carolina
•
Today
10+ years in IT with 6+ years in Business Analysis for regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with FDA 21 CFR Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA, GDPR; experienced in IQ/OQ/PQ documentation, SOPs, and audit-ready deliverables Strong domain knowled
Easy Apply
Full-time
Depends on Experience




