Sanofi is a global biopharmaceutical company committed to improving healthcare by developing innovative medicines and vaccines. With a strong focus on research and development, Sanofi aims to address unmet medical needs and enhance patient outcomes worldwide. The company fosters an inclusive, diverse, and collaborative work environment where employees drive progress and innovation.
Job Description
About the Role
The Electronic Document Specialist (eDS) will be part of the Clinical Electronic Document Management (CEDM) team under CSO-Clinical Documentation. The primary responsibilities include ensuring formatting, submission-readiness validation, and compilation of clinical documents within Sanofi’s electronic Document Management System (eDMS). The role involves collaborating with cross-functional teams, including Medical Writers, Regulatory, and Clinical Leaders, to ensure compliance with submission standards.
Key Responsibilities
- Perform format and submission-readiness validation of clinical documents as per Sanofi’s SOPs.
- Publish/compile non-complex clinical documents and ensure proper navigation for Health Authority submissions.
- Create and manage clinical documents in Sanofi’s eDMS, ensuring compliance with naming conventions and metadata standards.
- Set internal document links and support Clinical Study Report (CSR) publishing projects.
- Review publishing/compilation microplans, monitor appendix availability, and follow up with contributors.
- Conduct format validation on appendices and compile documents in the correct order.
- Electronically approve documents within the eDMS.
- Adapt to new technologies, including Artificial Intelligence (AI), to enhance document management processes.
Qualifications & Skills
- Bachelor’s degree in Life Sciences or related field (preferred).
- Pharmaceutical industry experience or document management background is a plus.
- Experience in formatting electronic documents or submission dossier compilation is desirable.
- Tech-savvy with strong MS Office 365 skills, particularly advanced MS Word formatting.
- Familiarity with eDMS (Vault RIM), publishing tools, and Acrobat (ISI Toolbox) is beneficial.
- Excellent communication, organizational, and multitasking skills.
- Ability to work 3 PM – 11 PM (IST) to collaborate with North American teams.
- Strong attention to detail, adaptability, and problem-solving mindset.
Why Join Sanofi?
At Sanofi, we believe in progress through diversity and innovation. We offer:
- A collaborative and inclusive work culture.
- Opportunities to work with cutting-edge technologies, including AI.
- Global exposure and career growth in a leading biopharmaceutical company.
- Commitment to diversity, equity, and inclusion—ensuring equal opportunities for all.
