ESR Associate Specialist

Sanofi; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sanofi Hyderabad seeks an Externally Sponsored Research (ESR) Associate Specialist to coordinate ESR activities across regions. You will ensure requests are processed efficiently, track budgets, and support FMV benchmarking within a GMP/GxP framework.

You will work with the BO team to manage study documentation, regulatory milestones, and data integrity, contributing to governance and operational excellence within a global biomedical operations context.

Qualifications

• Degree in medical/pharma or life sciences.
• 1–3 years of experience in clinical trials/clinical operations.
• Familiarity with medical systems and GxP is desirable.

Responsibilities

• Serve as coordination point for ESR activities across multiple countries and regions.
• Ensure study lifecycle management, financial compliance and research governance.
• Review FMV benchmarks and ESR budgets for accuracy and alignment with standards.
• Coordinate ESR requests in ESR System to ensure complete and compliant documentation.
• Support lifecycle management of externally sponsored research studies in ESR & FMV platforms.

Skills

Strong communication skills

Project management

Strategic thinking

English proficiency

Education

Degree in Medical/Pharma/Life sciences

Tools

MS Office

Power BI

SharePoint

Smartsheet

Project management tools

Job description

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

• Collaborates with team members and stakeholders to support project alignment, prioritization, and compliance with approved processes.
• Supports team initiatives and objectives by identifying and recommending process improvements and participating in company initiatives to add value to the business.

Performance

• Supports routine analysis of project objectives and deliverables to help identify potential risks, efficiencies, and ensure resources, budgets, and timelines are realistic.
• Tracks relevant project key performance indicators (KPIs) and proactively flags issues or proposes solutions to achieve the project plan.
• Identifies and evaluates alternative solutions to resolve or mitigate risks and escalates issues to ESR Managers as appropriate.
• Contributes operational insights to support team strategy and decision-making.
• Supports operational excellence and compliance by ensuring adherence to established standards and processes.

Process

• Supports as a key point of contact for FMV process-related queries, escalating complex matters to the ESR Manager as needed.
• Reviews ESR budgets to verify that total costs align with industry-practiced benchmarks.
• Provides project management support for ESR study management activities.
• Performs ESR quality control (QC) activities to ensure data accuracy and compliance with established standards.
• Supports ESR study management and data maintenance within the ESR system.

Stakeholder

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About you

• Experience: 1 to 3 years of relevant experience in clinical trials, clinical operations and should be familiar of Medical Systems; Having Medical programs knowledge and GxP knowledge is desirable

Soft skills

• Strong communication skills (written & verbal), innovative and creative thinking Ability to think strategically with a strong ability to execute and exceed stakeholder expectations and project goals.
• Ability to manage multiple projects simultaneously in a fast-paced, dynamic environment.

Technical skills

• MS Office (including Teams, SharePoint, Excel, Word, Outlook), project management tools such as Smartsheet, Power BI.

Education

Degree in a Medical/Pharma/scientific or a related Life science degree, with substantial project management or clinical trials and drug development experience.

Languages

Excellent knowledge of English language (spoken and written).

Why choose us?

Work where global operations meet bold ambition — supporting critical functions that help bring life-changing treatments to patients faster. Accelerate your career through internal gigs, cross-functional moves, and international mobility designed to grow your impact. Own meaningful work from day one, with the freedom to shape smarter solutions and lead change across a global business. Bring bold ideas to life using the latest tech — from AI and automation to digital tools that transform how we work. Collaborate with curious minds across borders, functions, and cultures in a fast-paced, purpose-driven environment. Thrive in a workplace designed for you — with vibrant, flexible spaces and benefits that support your well-being, growth, and sense of belonging. Pursue Progress. Discover Extraordinary. Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

Equal opportunities

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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 and check out our Diversity Equity and Inclusion actions at sanofi.com! 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 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 new 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.

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.