Hyderabad Full time R2874848 _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 solid 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 **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! We are an R&D; driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore recent opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.

📌 Global Supply Study Support (GSSS) (Hyderabad)
🏢 Sanofi Group
📍 Hyderabad