Externally Sponsored Research Specialist

Sanofi; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sanofi Business Operations in Hyderabad is hiring a Project Specialist - ESR (Externally Sponsored Research). You will manage ESR requests, liaise with global/local teams, assess sponsorship, and ensure compliance with internal procedures.

The role requires 3+ years in medical/clinical ops and 2+ years in international project leadership, strong English, and MS Office proficiency. This is a permanent, full-time position based in Hyderabad with travel as needed.

Qualifications

• Experience: 3+ years in medical or clinical operations and 2+ years of project management in an international environment.

Responsibilities

• Manage incoming ESR requests liaising with medical global/local teams and ensure ESRs are managed per internal procedures.
• Sponsor/Investigator assessment at study outline review stage.
• Evaluate external study proposals for ESR vs. Medical or R&D classification; coordinate reviewers.
• ESR records/document filing including audits and internal control.
• Quality Control of ESR data in Sanofi systems; liaise with stakeholders.
• Provide FMV review and approval for ESR studies.
• Support CDA creation and management for ESR studies.
• ESR study management in iEnvision.

Skills

Clinical operations

Project management

Communication

English language

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

Job title: Project Specialist - ESR (Externally Sponsored Research) Hiring Manager: Project Lead -ESR & Grants, Sanofi Business Operations Location: Hyderabad Job title: Project Specialist - ESR (Externally Sponsored Research) Hiring Manager: Project Lead -ESR & Grants, Sanofi Business Operations Location: Hyderabad Percentage of travel expected: Travel required as per business need Job type: Permanent and Full time

About the job

Our Team: Sanofi Business Operations (SBO) 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. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities

• Responsible to manage the incoming ESR requests liaising with the medical global and local teams and to ensure ESR are managed as per internal procedures
• Responsible for Sponsor/Investigator assessment at study outline review step (sponsor qualification checks).
• Act as first recipient of external study proposals submitted in the Sanofi system: evaluate and analyze the request, perform quality checks, identify whether the ESR is a Medical study or an R&D study, identify the Franchise (if any), identify the reviewers and liaise with them to ensure adequate review of the external study proposal by the appropriate review panel.
• Responsible for ESR records / document filing (audits, internal control).
• Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system.
• Liaise with appropriate stakeholders.
• Provides Fair Market Value (FMV) review and approval to ensure appropriate evaluation criteria are being utilized to provide appropriate benchmarked compensation when ISS /ESC studies are engaged to provide a service to the Sanofi companies
• Provides project management support for CDA creation and management ESR studies
• Provides ESR QC activities and ESR study management in iEnvision

People

• Seek alignment with team members and key stakeholders to ensure integration and appropriate prioritization of projects across the portfolio, and compliance with approved processes
• Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

Performance

• Conduct routine critical analyses of project objectives and deliverables to proactively identify potential risks and possible efficiencies, and ensuring resources, budgets and project timelines are optimized and realistic
• Track relevant project key performance indicators (KPIs) and proactively identify issues and proposals to achieve the project plan
• Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate
• Contributing to the overall strategy by bringing operational expertise
• Ensure operational excellence and compliance readiness

Process

• Lead governance and stakeholder alignment for SRC meetings, ensuring efficient review of CSS, ESC, ISS, and Global Health Studies. Manage documentation, compliance, and act as the primary liaison for study requestors and global partners.
• Primary point of contact for FMV and CDA process
• To review the ESRs budget and to verify that total cost is within the benchmarks practiced within the industry
• Project management support for CDA creation and management
• Supports the protocol QC activity
• ESR QC activities
• ESR study management in iEnvision

Stakeholder

Work closely with stakeholders from various GBUs, Sanofi Business Operations Activity teams & SBO leadership

About you

• Experience: 3+ years of experience in medical or clinical operations and 2+ years of professional experience managing projects in an international environment, demonstrating effective communication and leadership
• Soft skills: Diplomatic, Intercultural sensitivity, effective leadership on peer-to-peer level
• Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
• Education: Degree in a scientific discipline or related degree with substantial project management and/or project leadership experience
• Languages: Excellent knowledge of English language (spoken and written)

Pursue progress, discover extraordinary 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. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

% of travel expected: Travel required as per business need Job type: Permanent and Full time

About the job

Our Team: Sanofi Business Operations (SBO) 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. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities

• Responsible to Set up and Managing and Scientific Review Committee (SRC) to review approval meetings for all 4 committee reviews - Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), ISS, Global Health Studies as per the established operating model.
• Responsible to manage the incoming ESR requests liaising with the medical global and local teams and to ensure ESR are managed as per internal procedures
• Support ESR manager for ESR operational activities
• Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system.
• Liaise with appropriate stakeholders.
• Provides ESR QC activities and ESR study management in iEnvision for all GBU
• Support for ESR records / document filing (audits, internal control).
• Provides Fair Market Value (FMV) review and approval
• Provides support for CDA creation and management, if needed

People

• Seek alignment with team members and key stakeholders to ensure integration and appropriate prioritization of projects across the portfolio, and compliance with approved processes
• Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

Performance

• Conduct routine critical analyses of project objectives and deliverables to proactively identify potential risks and possible efficiencies, and ensuring resources, budgets and project timelines are optimized and realistic
• Track relevant project key performance indicators (KPIs) and proactively identify issues and proposals to achieve the project plan
• Proactively identifies and evaluates alternative solutions to resolve/mitigate and elevate risks and/or issues as appropriate
• Contributing to the overall strategy by bringing operational expertise
• Ensure operational excellence and compliance readiness

Process

• Lead governance and stakeholder alignment for SRC meetings, ensuring efficient review of CSS, ESC, ISS, and Global Health Studies. Manage documentation, compliance, and act as the primary liaison for study requestors and global partners.
• Primary point of contact for FMV and CDA process
• To review the ESRs budget and to verify that total cost is within the benchmarks practiced within the industry
• Project management support for CDA creation and management
• Supports the protocol QC activity
• ESR QC activities
• ESR study management in iEnvision

Stakeholder

Work closely with stakeholders from various GBUs, Sanofi Business Operations Activity teams & SBO leadership

About you

• Experience: 3+ years of experience in medical or clinical operations and 2+ years of professional experience managing projects in an international environment, demonstrating effective communication and leadership
• Soft skills: Diplomatic, Intercultural sensitivity, effective leadership on peer-to-peer level
• Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
• Education: Degree in a scientific discipline or related degree with substantial project management and/or project leadership experience
• Languages: Excellent knowledge of English language (spoken and written)

Pursue progress, discover extraordinary 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. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary 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. 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 movieWe 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.