Associate Director, R&D IT

Job Summary

Partnering with R&D and Commercial stakeholders, the full-time remote Associate Director, R&D IT will lead the transition of regulatory information management systems, serve as system administrator for validated R&D and Commercial applications, and ensure compliance with regulatory standards.

Key responsibilities

• Lead the transition from Veeva Vault RIM to Generis CARA, managing scope, timeline, data migration, and stakeholder coordination
• Collaborate with various departments to understand business needs and deliver IT solutions that align with those requirements
• Administer and maintain R&D and Commercial applications, ensuring they are validated and compliant with FDA regulations

Required qualifications

• Bachelor's degree in Information Systems, Computer Science, Life Sciences, or a related field, or equivalent experience
• 10+ years of IT experience in biotech, pharmaceutical, or life sciences, including 5+ years supporting R&D or clinical/regulatory systems
• Hands-on experience with Veeva Vault, Argus Safety, or similar regulated R&D applications
• Working knowledge of GxP, 21 CFR Part 11, and computer system validation
• Experience managing vendors and leading system implementations or migrations