Associate Director, R&D and Commercial IT
Core
Lead the transition of regulatory information management from Veeva Vault RIM to Generis CARA and serve as system owner for R&D and Commercial applications in a biotech setting.
Role type
Senior IC IT system administrator and project lead
Builds
Validated R&D and Commercial IT systems for clinical development, regulatory, safety, and commercial operations
Domain
Biotechnology / Life Sciences / Regulated IT
Required skills
Veeva Vault administration, GxP compliance, system validation, vendor management, project management, stakeholder collaboration, change control, incident management
Preferred skills
Generis CARA experience, Veeva CRM/Network/PromoMats, cell/gene therapy domain knowledge, PMP certification
Technologies
Veeva Vault, Generis CARA, Argus, DocuBridge, Magnifi LMS, Veeva CRM, Veeva Network, Veeva PromoMats
Responsibilities
Lead Veeva Vault RIM to Generis CARA transition including data migration and validation; Partner with Clinical Data Management, Regulatory Affairs, and Drug Safety to deliver IT solutions; Manage user access, security roles, and releases for R&D and Commercial applications; Ensure systems comply with FDA 21 CFR Part 11 and GxP; Direct vendor resources and manage SLAs; Provide escalation support and drive root-cause analysis; Contribute to budgets and roadmaps for the application portfolio
Seniority
Senior, hands-on IC with leadership responsibilities