Associate Director, Regulatory Systems & RIM Lead

Iovance Biotherapeutics, Inc.; United States; À distance; USD 120 000 - 170 000; Plein temps

Résumé du poste

Iovance Biotherapeutics, Inc. is seeking a systems professional to manage validated R&D and commercial applications, ensuring FDA compliance and data integrity. The role supports clinical development, regulatory, safety, and commercial operations.

Responsibilities include leading the transition from Veeva Vault RIM to Generis CARA, coordinating scope, timeline, data migration, and vendor activities, and acting as the system administrator for a portfolio of validated applications.

Qualifications

• Experience managing validated systems in FDA-regulated environments.
• Experience with RIM platforms such as Veeva Vault or Generis CARA preferred.
• Ability to coordinate data migrations and vendor activities.

Responsabilités

• Partner with R&D and Commercial stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations.
• Lead the transition from Veeva Vault RIM to Generis CARA, including scope, timeline, data migration, and vendor coordination.
• Serve as system administrator for a portfolio of validated R&D and Commercial applications, ensuring compliance with FDA regulations.

Connaissances

RIM systems administration

Veeva Vault

Generis CARA

Regulatory compliance

FDA regulations

Outils

Veeva Vault

Generis CARA

Description du poste

Iovance Biotherapeutics, Inc. is seeking a systems professional to manage validated R&D and commercial applications, ensuring FDA compliance and data integrity. The role supports clinical development, regulatory, safety, and commercial operations.

Responsibilities include leading the transition from Veeva Vault RIM to Generis CARA, coordinating scope, timeline, data migration, and vendor activities, and acting as the system administrator for a portfolio of validated applications.