R&D Clinical eDS -
Location:
Hyderabad, India
Job Type:
Permanent
Posted On:
March 28, 2025
Expires On:
April 18, 2025
About the Job:
Sanofi is seeking an R&D Clinical eDS to join the Clinical Electronic Document Management (CEDM) subgroup of CSO-Clinical Documentation. This role ensures the format and submission-readiness validation of clinical documents within the Sanofi electronic Document Management System (eDMS) and supports the compilation and publishing of non-complex documents required for submission to health authorities.
Main Responsibilities:
Format and Submission-Readiness Validation:
Validate clinical documents to ensure they meet Sanofi requirements per SOPs and guidelines.
Format documents for submission and ensure compliance with regulatory standards.
Document Compilation & Publishing:
Publish/compile non-complex clinical documents with multiple components.
Set internal links within documents and ensure compliance with naming conventions and metadata.
Clinical Study Report (CSR) Support:
Review and confirm feasibility of publishing/compilation microplans provided by Sanofi Medical Writers.
Monitor the availability of appendices and follow up with contributors.
Validate format and submission-readiness of appendices.
Compile and order documents correctly for submission.
Electronic Document Approval:
Approve all clinical documents electronically within the eDMS.
About You:
Work Schedule:
Flexibility to work 3 PM – 11 PM (local time) to collaborate with North America-based teams.
Experience:
Preferred experience in the pharmaceutical or related industry.
Document management experience and familiarity with submission dossiers is an advantage.
Knowledge or experience with Artificial Intelligence (AI) is desirable.
Skills & Competencies:
Strong verbal, written, and organizational skills.
Highly self-motivated, proactive, and detail-oriented.
Ability to handle multiple tasks, work under pressure, and adapt to change.
Strong team collaboration with a multicultural and multifunctional mindset.
Digital and tech-savvy with expertise in MS Office 365, especially MS Word.
Experience with eDMS tools such as Vault RIM, publishing tools, and Acrobat (ISI Toolbox) is desirable but not mandatory.
Education:
Bachelor’s degree in life sciences or a related field preferred.
Strong command of English, both written and verbal.
Why Join Us?
Inclusive Culture: We provide equal opportunities and foster an environment where diversity is valued.
Career Development: Opportunities for growth, mentorship, and professional advancement.
Collaborative Environment: Join a team that promotes continuous learning and innovation.
About Sanofi:
Sanofi believes in creating equal opportunities for all, irrespective of race, gender, orientation, disability, or background. Our mission is to push boundaries, innovate, and make extraordinary progress.
Learn More: sanofi.com
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