Corbus Pharmaceuticals

Director

• Serve as the business owner and subject matter expert (SME) for document management
• Lead document management strategy and continuous improvement initiatives
• Act as the primary point of escalation and strategic advisor for document management
• Provide leadership and oversight for TMF/eTMF health, compliance metrics, risk identification, issue remediation, and inspection preparedness
• Support audits, regulatory inspections, sponsor oversight activities, and vendor qualification efforts
• Partner with Quality Assurance to develop, maintain, and improve SOPs, work instructions, guidance documents, and training materials
• Oversee document management activities performed by external partners
• Lead the administration and optimization of Veeva Vault and other EDMS platforms
• Develop and deliver training on EDMS platforms and document management processes

Associate Director, Document Management, Inspection Readiness