Sanofi, a global biopharmaceutical leader, is hiring for two critical clinical documentation roles at its Hyderabad R&D Hub:
R&D eTMF Document Specialist and R&D TMF Support Team Lead. These full-time opportunities are ideal for professionals with experience in clinical trial documentation, eTMF systems, ICH-GCP, and regulatory compliance.
If you are looking to build or advance your career in clinical research documentation, TMF management, or inspection readiness, this is a high-impact opportunity with a globally recognized organization.
📌 Available Positions
1️⃣ R&D eTMF Document Specialist
📍 Location: Hyderabad
🆔 Job Requisition ID: R2839743
🗓 Apply By: 4 February 2026
2️⃣ R&D TMF Support Team Lead
📍 Location: Hyderabad
🆔 Job Requisition ID: R2832243
🗓 Apply By: 4 February 2026
🔬 Key Responsibilities
R&D eTMF Document Specialist – Responsibilities
- Manage Trial Master File (TMF) documents across study, country, and site levels
- Ensure eTMF completeness, accuracy, and inspection readiness
- Perform metadata completion and quality control (QC) checks
- Conduct Expected Document List (EDL) reviews and file reconciliation
- Support Veeva Vault eTMF users and contributors
- Coordinate query resolution and document corrections
- Assist with audit and regulatory inspection preparation
- Track TMF metrics and quality indicators
- Contribute to TMF SOPs, training materials, and process improvements
R&D TMF Support Team Lead – Responsibilities
- Lead and manage the TMF Support Team within the Hyderabad Hub
- Oversee inspection readiness, QC, and TMF migration activities
- Collaborate with global stakeholders on metrics, performance, and prioritization
- Ensure compliance with health authority regulations and Sanofi SOPs
- Drive process excellence, innovation, and operational efficiency
- Mentor team members and support hiring, training, and performance management
- Act as a change agent for new TMF systems and technologies
- Support audits, inspections, legal requests, and organizational initiatives
🎓 Qualifications & Experience
For eTMF Document Specialist
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Experience in eTMF management or clinical documentation
- Strong knowledge of ICH-GCP and clinical trial processes
- Hands-on experience with Veeva Vault eTMF (preferred)
- Excellent attention to detail and organizational skills
- Strong written and verbal English communication
For TMF Support Team Lead
- Bachelor’s degree in Life Sciences or equivalent
- 3–5+ years of industry experience, including people management
- Strong understanding of drug development and TMF regulations
- Experience managing global, matrixed teams
- Proven leadership, change management, and stakeholder engagement skills
- Fluency in English (written and spoken)
💼 Salary & Benefits (Indicative)
- R&D eTMF Document Specialist: ₹6,00,000 – ₹10,00,000 per annum
- R&D TMF Support Team Lead: ₹15,00,000 – ₹25,00,000 per annum
Benefits include:
- Competitive compensation
- Exposure to global clinical programs
- Career growth in R&D and regulatory operations
- Inclusive and diverse work culture
- Learning and leadership development opportunities
🧾 How to Apply
Application Link For R&D eTMF Document Specialist
Application Link For R&D TMF Support Team Lead
