Externally Sponsored Research Specialist
ROLE OVERVIEW
Sanofi Business Operations (SBO) in Hyderabad seeks an Externally Sponsored Research Specialist to manage investigator-initiated and externally sponsored studies across Specialty Care, Vaccines, and General Medicines. This role is pivotal in ensuring that external research proposals align with Sanofi’s strategic priorities, comply with internal policies, and undergo rigorous scientific and financial review. By coordinating Scientific Review Committees, Fair Market Value assessments, and Clinical Trial Agreements, the specialist directly supports Sanofi’s pipeline and post-marketing commitments. This is an excellent career opportunity for clinical operations professionals to gain global exposure, work with cross-functional teams, and contribute to Sanofi’s mission of transforming patient outcomes. The position offers deep insight into medical affairs, regulatory compliance, and research governance within a top-tier pharmaceutical company.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage incoming Externally Sponsored Research (ESR) requests and liaise with global/local medical teams to ensure alignment with internal procedures.
- •Conduct sponsor/investigator assessments at study outline review and perform quality checks on external study proposals.
- •Identify whether ESRs are Medical or R&D studies, determine franchise alignment, and coordinate with appropriate review panels.
- •Lead governance and stakeholder alignment for Scientific Review Committee (SRC) meetings covering CSS, ESC, ISS, and Global Health Studies.
- •Perform Fair Market Value (FMV) review and approval to ensure benchmarked compensation for services in ISS/ESC studies.
- •Provide project management support for Clinical Trial Agreement (CDA) creation and management, including budget review against industry benchmarks.
- •Support protocol quality control (QC) activities and conduct ESR QC, maintaining accurate data in iEnvision.
- •Ensure ESR records/document filing for audits and internal controls, and act as primary point of contact for FMV and CDA processes.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree in a scientific discipline such as B.Pharm, M.Pharm, PharmD, MBBS, MD, MSc, BSc Nursing, or equivalent life sciences qualification.
- Minimum 3+ years of experience in medical or clinical operations within a pharmaceutical, CRO, or healthcare organization.
- At least 2+ years of professional project management experience in an international, cross-cultural environment.
- Proven ability to manage cross-functional stakeholders and lead peer-to-peer discussions with diplomacy and intercultural sensitivity.
- Excellent spoken and written English communication skills for effective global collaboration and documentation.
- High proficiency with Microsoft Office suite (Outlook, Excel, Word, PowerPoint) and relevant project management tools.
- Demonstrated knowledge of clinical research regulations and compliance requirements (e.g., ICH-GCP, local laws, and internal SOPs).
PREFERRED QUALIFICATIONS
- •Experience with Sanofi systems and processes
- •Knowledge of global regulatory submissions (FDA, EMA)
- •Budget benchmarking and financial analysis
- •Vendor and CRO management
- •Prior experience in Vaccines, Specialty Care, or General Medicines therapeutic areas
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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