R & D Professional- Global Supply Study Support

Sanofi

2 - 7 years

9 - 13 Lacs

hyderabad

Posted:7 hours ago| Platform:

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Skills Required

erp supply chain power bi clinical trials pharmaceutical production software testing drug safety manual testing clinical data management sharepoint irt pharmacovigilance veeva sql gcp clinical research clinical development invoicing argus meddra

Work Mode

Work from Office

Job Type

Full Time

Job Description

The GSSS will report to the GSSS Team Leader (India) and interact with the Clinical Supply Chain stakeholders.

Main responsibilities include:

Common: Clinical Trial & Supply Knowledge

Understandingof clinical trial design, protocols, regulatory requirements (GxP)
Understandingof clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors
Understandingof investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation, returns/destruction.

Level 1 responsibilities:

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.

Level 2 responsibilities:

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.
Manage service provider purchase orders and invoices, ensuring regular financial tracking and compliance.

About you

Bachelors degree required (advanced degree preferred, scientific discipline preferred) with at least 2 years of o perational experience in pharmaceutical production, Supply Chain, Quality and/or clinical trials.
Basic knowledge of clinical development, Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
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.
Near-native fluency written and spoken in English
Proficiency with MS Office applications (Word, Excel, SharePoint, PowerBI) and clinical trial digital applications (IRT, ERP, Veeva, etc.)
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