Jobs / India / Sanofi US Services INC
ESR Associate Specialist
Sanofi US Services INC · 🌍 Hyderabad
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About the role
About the job As Externally Sponsored Research (ESR) within our Business Operations (BO) team, you'll serve as a key coordination point for ESR activities across multiple countries and regions, ensuring requests are processed, and tracked efficiently in line with established SOPs. Based in Hyderabad, you'll be part of Business Operations (BO) team. Our Team: Sanofi Business Operations 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. Hyderabad Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main responsibilities: The Sanofi Business operations ESR Associate Specialist plays a key operational role within the Externally Sponsored Research (ESR) function, supporting the Specialty Care, Vaccines, and General Medicines Global Business Units. The role is responsible for ensuring effective study lifecycle management, financial compliance, and research governance. By maintaining alignment with Sanofi’s quality standards, ethical requirements, and industry benchmarks, the position helps ensure that externally sponsored research is conducted efficiently, compliantly, and with scientific integrity. • Supports Fair Market Value (FMV) review and approval by assisting in the evaluation of compensation benchmarks for Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). • Reviews clinical research budgets proposed by external sponsors using the established FMV evaluation process and escalates discrepancies to ESR Managers. • Reviews ESR requests in ESR System to ensure all required documentation and critical information are complete, accurate, and compliant with established standards. • Coordinates with ESR Managers and stakeholders to support FMV benchmark updates for accuracy and consistency. • Supports ESR Managers in the lifecycle management of externally sponsored research studies in the ESR & FMV platform, including data accuracy and system maintenance. • Assists in managing operational activities for ESRs from initial proposal submission to study closeout, including SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation, cross-reference letters, transfer of value reporting, payment tracking, and overall ESR program reporting. Ad-hoc activities – Supports ad-hoc activities as assigned. People: (1) Collaborates with team members and stakeholders to support project alignment, prioritization, and compliance with approved processes. (2) Supports team initiatives and objectives by identifying and recommending process improvements and participating in company initiatives to add value to the business. Performance: (1) Supports routine analysis of project objectives and deliverables to help identify potential risks, efficiencies, and ensure resources, budgets, and timelines are realistic. (2) Tracks relevant project key performance indicators (KPIs) and proactively flags issues or proposes solutions to achieve the project plan. (3) Identifies and evaluates alternative solutions to resolve or mitigate risks and escalates issues to ESR Managers as appropriate. (4) Contributes operational insights to support team str