Job title: R&D Associate Project Specialist - Archiving/Merger & Acquisition
Location: Hyderabad
About the job
Our Team:
Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions.
Main responsibilities:
The overall purpose and main responsibilities are listed below:
Records & Specimen Management
Track study records and specimens generated at external CROs to ensure their successful transfer to long-term storage.
Accurately log and track all materials within Sanofi's electronic document management systems (e.g., Argpege).
Perform reconciliations to identify and account for records/specimens that have not yet been moved to long-term storage.
Records Retention & Destruction
Follow established records retention policies to identify items eligible for destruction.
Verify the retention status of records and specimens before coordinating the destruction process.
Execute the secure destruction process for approved materials in a compliant manner.
Stakeholder & CRO Coordination
Coordinate with external CROs throughout North America to facilitate the transfer of materials.
Liaise with internal teams including US RIM (Records and Information Management), Outsourcing Managers, and the TMED Operations team to ensure smooth archival workflows.
Financial & Procurement Support
Launch purchase orders in Coupa/Ebuy to cover the costs of shipping and external storage.
Review and approve invoices from CROs and storage vendors to ensure accuracy and timely payment.
About you
Experience: Experience in a pharmaceutical environment, preferably with some experience in clinical documentation, records management, or a related operational role. Familiarity with electronic document management systems and global submission guidelines (FDA, EMA) is required.
Soft Skills: Excellent verbal and written communication skills in English, strong organizational skills, high attention to detail, ability to coordinate with multiple stakeholders.
Technical Skills: Argpeges, Microsoft Office (Excel, Word), Adobe Acrobat, Coupa/Ebuy, Outlook/Teams.
Education: Degree in pharma, chemistry, biology, or related disciplines is desirable.
Languages: English (fluent).
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