R&D Investigational Product Support

About the job

At Sanofi R&D, we develop future medicines that improve patients' lives worldwide. Our Clinical Supply Chain Operation (CSCO) department is responsible for packaging and distributing Investigational Medical Products (IMPs) to patients globally for clinical testing. The Investigational Product Support (IPS) role provides support - on activities that can be centralized - to a worldwide team of IPM (Investigational Product Manager) located in 30 countries in charge to manage locally the flow of our investigational products ensuring quality, timely delivery, regulatory compliance, and accurate tracking through our internal systems.

Main responsibilities include: The main mission is to provide administrative support to CSCO department on investigational product (IP) distribution scope

• Manage quotations, purchase orders, and change orders for local activities with carrier vendors and service providers
• Perform cost reconciliation and final payments with depots and other local service providers
• Perform temperature excursion assessment during transportation and storage for shipments to depots and sites
• Manage depot data changes in IRT tracking tools and provide carrier vendor with transfer request data for reception
• Perform tracking & reconciliation of studies assigned in CSCO tools and coordinate destruction authorizations for unused kits with local depot
• Support import license management and complete necessary forms for the request; support local IPMs to gather all documents needed for customs release.
• Provide filing and archiving support for IMP-related documents, including uploading documents into eTMF for inspection readiness

About you

• Strong organizational skills for managing multiple concurrent tasks

• Ability to work autonomously with methodology to respect guidelines.

• Ability to work effectively, proactively, and collaboratively in a worldwide, multi-cultural, multidisciplinary environment.

• Effective communication both written and verbal

• Adapt to changing work environment, including changes in technical environments.

• Languages:  Near-native fluency written and oral in English; additional languages (Near-native fluency written and verbal) are a valuable asset to manage local distribution documentation (i.e Spanish, French Chinese, Portuguese…)

• Proficiency with MS Office applications (Word, Excel, SharePoint)