Jessica Hunter

Lead cross-functional questionnaire, RFI/RFP, due diligence, and vendor assessment initiatives supporting commercial opportunities with $100M+ potential revenue. Drive content governance and workflow improvements, and serve on the Responsive Steering Committee.

Led FDA-regulated recall audits across product and food sectors, validating traceability, record integrity, and quality requirements. Documented findings and coordinated corrective actions.

Managed global vendor qualification, governance, and controlled documentation for multinational clinical trial and regulatory operations. Built SharePoint repositories and developed KPI frameworks for vendor performance.

Managed pharmacovigilance workflows including Oracle Argus processing, MedDRA coding, and global regulatory submissions. Partnered with quality leaders on documentation standards and audit metrics.

Coordinated oncology and translational trial documentation, IRB submissions, and sponsor records under GCP/ICH requirements. Created KPI dashboards and tracking systems for regulatory readiness.

Maintained FDA/IRB submissions, sponsor communications, and quality documentation for oncology and women's health studies. Implemented reporting and tracking controls.

Conducted compliance investigations, due diligence, CAPA documentation, and risk assessments aligned with FDA and DEA requirements. Created executive dashboards and vendor tracking tools.

Juris Master / Master of Legal Studies in Pharmaceutical & Medical Device Law and Compliance.

Bachelor of Science in Human & Social Service Administration.