R&D eTMF Document Specialist Job At Sanofi
Sanofi is hiring an R&D eTMF Document Specialist in Hyderabad to manage electronic Trial Master File (eTMF) systems, ensuring clinical trial documentation is accurate, compliant, and inspection-ready. This Pharmacy Job role is perfect for life sciences graduates seeking to advance their career in clinical operations and regulatory documentation. Graduates seeking B Pharma jobs or Pharma Jobs can apply now.
Job Details
- Job Title: R&D eTMF Document Specialist
- Location: Hyderabad, India
About the Company
Sanofi is a global biopharmaceutical leader driving innovation across oncology, rare diseases, vaccines, and neurology. The company invests in science, AI-powered research, and talent development to deliver better medications, outcomes, and patient impact. Sanofi promotes diversity, equity, and inclusion across all levels of the organization.
Educational Requirements
- Bachelor’s degree in Pharmacy
- Knowledge of ICH-GCP and clinical development processes preferred
Key Responsibilities
- Manage TMF documents and metadata in the eTMF system in compliance with regulations
- Perform quality control, EDL checks, and ensure completeness of study files
- File documents in multiple languages and ensure proper indexing
- Coordinate task management, error corrections, and query responses
- Support study teams, TMF managers, and vendors in process adherence
- Facilitate audit and inspection preparation, including document retrieval
- Contribute to SOPs, training materials, and process improvement initiatives
- Track TMF metrics, quality indicators, and system evolution/testing
Skills Required
- Experience with eTMF management or clinical documentation (Veeva Vault preferred)
- Knowledge of ICH-GCP, regulatory requirements, and clinical trials
- Strong attention to detail and organizational skills
- Excellent written and verbal communication in English
- Problem-solving, analytical skills, and adaptability to new technologies
- Ability to prioritize tasks and meet deadlines in a fast-paced environment
- Team player with ability to work independently
Why This Job Role?
This Pharmacy Job role offers exposure to global clinical trial operations and regulatory compliance. It is ideal for professionals seeking to specialize in eTMF management while contributing to high-impact clinical studies across oncology, vaccines, and rare diseases. Graduates seeking B Pharma jobs or Pharma Jobs can apply now.
