Sanofi, a global leader in healthcare and pharmaceuticals, is seeking a highly motivated and detail-oriented R&D Clinical eDS (electronic Document Specialist) to join its team in Hyderabad, India. This is a permanent role offering an exciting opportunity to work in a dynamic environment focused on innovation, collaboration, and progress.
Our Team
The electronic Document Specialist (eDS) role is part of the Clinical Electronic Document Management (CEDM) subgroup within CSO-Clinical Documentation. The eDS plays a critical role in ensuring the format and submission-readiness of clinical documents prepared in Sanofi’s official electronic Document Management System (eDMS). The role involves compiling and publishing non-complex documents, implementing navigation for clinical electronic documents, and supporting submissions to Health Authorities.
The eDS collaborates closely with internal teams, including medical writers, record managers, and contributors from other functional areas such as Regulatory, Pharmacology, Statistics, and Clinical Leaders. This role also involves working with cutting-edge technologies, including Artificial Intelligence (AI), in an ever-evolving environment.
Key Responsibilities
As an R&D Clinical eDS, your primary responsibilities will include:
- Format and Submission-Readiness Validation:
- Ensure clinical documents meet Sanofi’s requirements as per SOPs and guidelines.
- Validate the format and readiness of documents for submission.
- Document Compilation and Publishing:
- Publish and compile clinical documents with multiple components.
- Support the publishing of Clinical Study Reports (CSRs) by reviewing timelines, monitoring appendix availability, and performing validation checks.
- Document Creation and Management:
- Create clinical documents in the Sanofi eDMS, ensuring compliance with naming conventions and metadata requirements.
- Set internal links within documents and ensure proper navigation.
- Collaboration and Follow-Up:
- Work closely with medical writers and contributors to ensure timely delivery of documents.
- Follow up with stakeholders to ensure the availability of required appendices.
- Electronic Approval:
- Electronically approve clinical documents within the eDMS.
About You
To excel in this role, you should possess the following qualifications and skills:
- Flexibility: Ability to work from 3 PM to 11 PM local time to collaborate with teams based in North America.
- Experience:
- Preferred experience in the pharmaceutical or related industry.
- Document management experience is an advantage.
- Knowledge of formatting electronic documents and submission dossiers is desirable.
- Familiarity with Artificial Intelligence (AI) is a plus.
- Skills:
- Excellent verbal, written, organizational, and interpersonal skills.
- Strong attention to detail and the ability to handle multiple tasks simultaneously.
- Proficiency in MS Office 365, particularly advanced MS Word formatting.
- Familiarity with tools like Vault RIM, publishing tools, and Acrobat (ISI Toolbox) is a bonus.
- Education: A Bachelor’s degree in Life Sciences or a related field is preferred.
- Language: Strong command of English, both verbal and written.
Why Join Sanofi?
At Sanofi, we believe in pursuing progress and discovering extraordinary solutions. We are committed to creating a diverse and inclusive workplace where everyone has equal opportunities to thrive. Our mission is to provide better medications, better outcomes, and better science, and we need passionate individuals like you to make this happen.
- Diversity, Equity, and Inclusion: Sanofi is dedicated to fostering an inclusive environment where everyone feels valued and respected, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
- Innovation and Collaboration: Work with cutting-edge technologies and collaborate with multicultural, multifunctional teams in a matrix organization.
- Career Growth: Be part of a global organization that encourages professional development and offers opportunities to explore new ideas and technologies.
