R&D Project Specialist - Archiving/Merger & Acquisition

Job title: R&D 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:

Archival Process Management

Manage the end-to-end process of transferring study records and specimens from external CROs to long-term storage, ensuring timeliness and compliance.

Oversee the accurate tracking of all materials in Sanofi’s systems, acting as a subject matter expert for data integrity.

Lead reconciliation efforts to resolve complex discrepancies and ensure a complete inventory of all study-related materials.

Records Retention & Compliance

Interpret and apply records retention policies to accurately schedule items for destruction.

Provide guidance to stakeholders on retention requirements and manage the verification process to prevent premature destruction of critical records.

Oversee the compliant destruction process, ensuring all documentation and approvals are in place.

Stakeholder & Vendor Relationship Management

Serve as the primary liaison between external CROs and internal Sanofi teams (US RIM, Outsourcing, TMED Ops) to resolve issues and streamline archival operations.

Build and maintain strong working relationships with vendors to ensure high-quality service and adherence to timelines.

Financial Oversight & Procurement

Oversee the financial tracking of archiving activities, including managing purchase orders and ensuring accurate and timely processing of invoices in Coupa/Ebuy.

Monitor spending against budget and resolve any financial discrepancies with vendors or internal finance teams.

Process Improvement

Identify opportunities to enhance the efficiency and compliance of archiving workflows and systems.

Contribute to the development and maintenance of Standard Operating Procedures (SOPs) for records management.

Support audit readiness by ensuring all archival activities are well-documented and traceable.

About you

Experience: Direct experience in pharmaceutical records management, clinical operations, or TMF (Trial Master File) management. Proven experience with electronic document management systems and an in-depth knowledge of FDA and EMA guidelines are essential.

Soft Skills: Excellent communication and interpersonal skills, strong analytical and problem-solving abilities, project coordination skills, and the ability to work independently and manage priorities effectively.

Technical Skills: Proficiency in Argpeges, Microsoft Office (Advanced Excel, Word), Adobe Acrobat, Coupa/Ebuy, Outlook/Teams.

Education: Degree in pharma, chemistry, biology, or related disciplines is desirable.

Languages: English (fluent).