R&D eTMF Document Specialist at Sanofi Careers | Pharma Jobs in Hyderabad
Looking for exciting Sanofi careers and Pharma Jobs in Hyderabad? Sanofi is hiring an R&D eTMF Document Specialist to manage electronic Trial Master File (eTMF) documentation, ensure regulatory compliance, and support clinical study teams. This is an excellent opportunity to advance your career in the pharmacy sector while contributing to innovative medical research in the category of Pharma jobs Hyderabad.
Job Details:
- Job Title: R&D eTMF Document Specialist
- Location: Hyderabad
About The Company:
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 who explore Sanofi careers.
Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Job Description:
The eTMF Specialist plays a crucial role in managing the Trial Master File (TMF) documentation system, ensuring compliance with regulatory requirements and internal processes throughout the lifecycle of clinical studies. This position is responsible for maintaining the integrity and quality of clinical trial documentation, supporting study teams, and facilitating regulatory inspections. Embarking on Sanofi careers means engaging in such vital roles.
As the central point of TMF oversight, the eTMF Specialist performs documentation activities across all levels within a study (study, country, and site), maintaining a comprehensive view of TMF completeness and quality. They collaborate closely with the TMF manager, Clinical Operations Study Leaders (COSLs), Global Study Leaders (GSLs), the Clinical Operations Study Country Leader (COSCL) Site Monitor (SM) and other study team members to ensure proper documentation practices are followed.
The eTMF Specialist executes tasks with integrity, ensuring all activities are suitable for regulatory review. They work alongside various stakeholders, including the TMF management team, clinical study teams, CROs, and investigational sites.
Key responsibilities at Sanofi Careers:
- Manage TMF documents in accordance with internal processes and applicable regulations
- Filing of documents regardless of language in eTMF
- Complete Metadata completion and quality control
- Creation, coordination and FU of User task management
- File review and Expected Document List (EDL) checks in coordination with TMF manager
- Check consistency between documents, initiate regular file checks, FU on actions, communicate findings with study teams for action
- Ensure completeness of study file at all times, share EDLs with TMF manager, COSL and COSCL, FU with study teams in case of issues
- Perform independent quality control of documents submitted to the TMF, review and verify proper indexing of documents in the eTMF system.
- Coordinate error corrections and manage query responses. Alert appropriate stakeholders and TMF manager of recurring issues or specific concerns
- Support TMF Contributors on processes and system usage. Support audit and inspection preparation activities.
- Contribute to document retrieval during regulatory inspections. Participate in process improvement initiatives.
- Support eTMF system evolution and testing. Track and report on TMF metrics and quality indicators.
- Liaise with TMF managers, clinical study teams, and vendors on TMF-related matters.
- Contribute to the development of TMF-related training materials and SOPs.
Qualification Required For Sanofi Careers:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Experience in eTMF management or clinical documentation is a plus
- Knowledge of ICH-GCP, regulatory requirements, and clinical development process
- Experience with electronic TMF systems (Veeva Vault experience preferred) is a plus, potentially enhancing prospects in Sanofi careers.
- Strong attention to detail and organizational skills
- Excellent written and verbal communication skills in English
- Ability to work independently and as part of a team
- Problem-solving and analytical skills
- Customer service orientation
- Adaptability to new technologies and processes
- Ability to prioritize tasks and meet deadlines in a fast-paced environment
