Global Supply Study Support (GSSS)

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 Global Supply Study Support (GSSS) provides support to a worldwide team of CSC SL (Clinical Supply Chain Study Leader) located mainly in USA, France and China in charge to coordinate the flow of our investigational products ensuring quality, timely delivery, regulatory compliance, and accurate tracking through our internal systems.
The Associate GSSS and GSSS will report to the GSS Team Leader and interact with the Clinical Supply Chain stakeholders.
This job description covers two career levels within the GSSS function. The Associate GSSS is the entry-level position focused on operational execution and support. The GSSS builds upon full mastery of the Associate GSSS scope, adding subject matter expertise, coaching and documentation ownership.
Main responsibilities: Global Supply Study Support (GSSS)
Create and manage transfers to depot in IRT, customize them in Sanofi supply tool and maintain the Inventory Product Stock Management (IPSM) tracker.
Manage destruction of expired IMP and AxMP throughout the study lifecycle, performing appropriate actions in related Sanofi tools (ERP, RAID…)
Monitor IRT interface failures with Sanofi supply tools and promptly alert the CSC SL.
Support CSC SL by accurately capturing supply plans in Sanofi Clinical Supplies tools (ERP)
Perform global reconciliation of studies in Sanofi supply tools and follow up discrepancy investigations with appropriate stakeholders (CSC SL, IPMs, CRA, Investigational sites)
Provide filing and archiving support for IMP-related documents, including uploading documents into eTMF to ensure inspection readiness.
Support the CSC SL in monitoring IMP and AxMP stock levels throughout the study. Alert Promptly CSC SL in case of shortage risk.
Assist the CSC SL in tracking shipments throughout the study duration.
Prepare and maintain mandatory shipment documentation prior shipment preparation (value for custom, country-specific documentation, study pre-requisite documents)
Support the CSC SL in preparation for regulatory inspections.
Additional Responsibilities and Skills: GSSS:
Prerequisites: Demonstrate full mastery of tools, processes, and skills involved in associate GSSS responsibilities
Peer support: Provide functional coaching to users, particularly new team members, and perform quality checks and peer reviews to support right-first-time execution and compliance.
Subject Matter Expertise/ Key Users: Act as the functional and technical SME/KU for assigned processes. Provide expert guidance, risk assessments, and issue resolution to enable informed decision-making across study teams.
Documentation, Knowledge contribution: Contribute to the development and maintenance of technical notes, lessons learned, FAQs and other knowledge-sharing materials for their assigned processes to promote consistent process execution and reduce recurring errors. Promote adherence to standards, relay process updates, best practices, and system enhancements to the team.
Process Improvement contribution: Identify and escalate opportunities for process improvements, standardization, and automation to support continuous improvement initiatives.
Behavioral Excellence: Demonstrate strong or outstanding skills in the following area:
Collaboration and ownership having pro-active communication and strong stakeholder management and relationship building in multicultural environment. Ability to collaborate, communicate to resolve conflicts, to escalate issues clearly across cultures successfully
Solution oriented: proactively identify risks, issues and make proposals
Flexibility and Agility: demonstrate ability to adapt to situations, challenges and work under stress
About You
Experience: 6-8 years of operational experience in pharmaceutical production, Supply Chain, Quality and/or clinical trials.
Education: Bachelor’s degree required (advanced degree preferred, scientific discipline preferred)
Soft and Technical Skills: Basic knowledge of clinical development including understanding clinical trial design, clinical protocols, clinical endpoints, patient randomization processes, dosing regimens, cohort management, stratification factors.
Understanding of regulatory requirements (GxP) (Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)).
Understanding of investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation.
Strong organizational skills with ability to manage multiple concurrent tasks efficiently.
Demonstrated ability to work autonomously with methodology approach to meet guidelines and deadlines.
Experience working in a global, multi-cultural, multidisciplinary environment.
Effective communication both written and verbal
Adaptability to changing and challenging work environments, including technical environments changes.
Proficiency with MS Office applications (Word, Excel, SharePoint, PowerBI) and clinical trial digital applications (IRT, ERP, Veeva, etc.)
Language: Near-native fluency written and spoken in English

Work arrangement
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