Sanofi, a global leader in biopharmaceutical innovation, is now hiring for two impactful R&D roles—R&D eTMF Document Specialist and R&D TMF Support Team Lead—at its Hyderabad hub.
These positions play a vital role in clinical documentation management, TMF compliance, inspection readiness, and global study support, offering excellent growth for life-science professionals.
If you’re seeking a career in clinical research documentation, TMF management, or R&D support functions, these Sanofi jobs provide a strong pathway to leadership and global exposure.
✅ 1. R&D eTMF Document Specialist – Hyderabad
Role Overview
The R&D eTMF Document Specialist will manage Trial Master File (TMF) documentation across clinical studies, ensuring accuracy, completeness, and inspection-readiness. The role involves close collaboration with global study teams, TMF managers, and CRO partners.
Key Responsibilities
- Manage and maintain TMF documents as per ICH-GCP and Sanofi SOPs
- Perform metadata entry, indexing, document QC, and file reviews
- Conduct Expected Document List (EDL) checks and track TMF completeness
- Coordinate corrections, resolve documentation queries, and manage user tasks
- Support audits, inspections, and TMF retrieval activities
- Collaborate with study teams, SMs, COSLs, COSCLs, vendors
- Support TMF process improvements, system testing, and training
- Track and report TMF metrics and deviations
Qualifications
- Bachelor’s degree in Life Sciences / Pharmacy
- Experience in eTMF systems (Veeva Vault preferred)
- Strong understanding of ICH-GCP & clinical research processes
- High attention to detail & organization
- Strong English communication skills
- Ability to work cross-functionally in a fast-paced environment
Benefits
- Opportunity to work in a global R&D environment
- Exposure to TMF inspection-readiness and regulatory documentation
- Career growth within clinical operations and TMF management
- Inclusive, diversity-driven workplace
✅ 2. R&D TMF Support Team Lead – Hyderabad
Role Overview
The TMF Support Team Lead will oversee the TMF support team, ensuring high-quality documentation outcomes, inspection readiness, and efficient operations across global studies.
Key Responsibilities
- Lead and mentor TMF support staff in Hyderabad hub
- Manage TMF QC, migrations, and inspection-readiness activities
- Collaborate with global TMF & R&D functional leads
- Drive process improvements, innovation, and team development
- Manage budgets, hiring, training, and performance tracking
- Support audits, legal requests, mergers, and system upgrades
- Foster a change-agile, compliant work culture
Qualifications
- Bachelor’s degree in Life Sciences/related field
- 3–5 years of industry experience with leadership exposure
- Knowledge of GCP, drug development, documentation guidelines
- Strong team management, negotiation, and conflict resolution skills
- Ability to work across global time zones
Benefits
- Leadership role in a global R&D TMF environment
- Strong career acceleration into operations management
- Opportunity to lead high-impact documentation functions
- Exposure to global TMF, regulatory, and audit teams
📝 How to Apply
Application Link For R&D eTMF Specialist
Application Link For TMF Support Team Lead
