R&D Senior eDS Specialist -
Hyderabad, India
Permanent
March 28, 2025
April 16, 2025
Sanofi is seeking an R&D Senior eDS Specialist to join the Clinical Electronic Document Management (CEDM) subgroup of CSO-Clinical Documentation. This role ensures format and submission-readiness validation of clinical documents prepared within the Sanofi electronic Document Management System (eDMS) and provides expert-level support in publishing and compiling non-complex documents for submission to health authorities.
The Senior eDS Specialist works closely with Sanofi teams, including medical writers, record managers, and contributors from multiple functional areas such as Regulatory, Pharmacology, Statistics, Clinical Leaders, and Project Leaders.
Format and Submission-Readiness Validation:
Validate clinical documents for compliance with Sanofi SOPs and guidelines.
Ensure submission-readiness of documents for health authorities.
Document Compilation & Publishing:
Compile and publish non-complex clinical documents.
Create clinical documents in the Sanofi eDMS and maintain conformity (naming conventions, metadata, etc.).
Set internal links and ensure document integrity.
Clinical Study Report (CSR) Support:
Review and validate feasibility of publishing/compilation microplans provided by Medical Writers.
Monitor availability of appendices and follow up with contributors.
Validate format and submission-readiness of appendices.
Compile all required documents in the correct order.
Electronic Document Approval:
Approve all clinical documents electronically within the eDMS.
Computer Technology Expertise:
Function as an expert user of software and systems.
Propose technical solutions based on previous experience and expertise.
Leadership:
Lead projects by collaborating orally and in writing with English-speaking colleagues globally.
Organization and Prioritization:
Manage multiple tasks and prioritize workload to meet deadlines and business needs.
Process Improvement:
Identify opportunities to streamline processes and improve ways of working.
User Testing:
Conduct user testing of new tools and applications when required.
Training and Mentoring:
Serve as a Subject Matter Expert (SME) to train eDS colleagues and support users/customers.
Experience:
Pharmaceutical industry experience or related industry experience preferred.
Document management experience is an advantage.
Familiarity with formatting electronic documents and submission dossiers desirable.
Knowledge or experience with Artificial Intelligence (AI) is a plus.
Skills & Competencies:
Strong verbal, written, and organizational skills.
Self-motivated, detail-oriented, and capable of managing multiple tasks simultaneously.
Assertive, diplomatic, and willing to ask for help when needed.
Strong problem-solving skills, adaptability to change, and ability to work under pressure.
Excellent collaboration skills with a multicultural and multifunctional mindset.
Digital and tech-savvy with solid knowledge of MS Office 365, including advanced competency in MS Word.
Technical Skills:
Experience with eDMS tools such as Vault RIM, publishing tools, and Acrobat (ISI Toolbox) is desirable.
Education:
Bachelor’s degree in life sciences or a related field preferred.
Strong command of English, both written and verbal.
Inclusive Culture: We provide equal opportunities and foster a culture where diversity is valued.
Career Development: Opportunities for growth, mentorship, and professional advancement.
Collaborative Environment: Work with teams across the globe and contribute to groundbreaking projects.
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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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Manila |Croatia :
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Japan | Saitama |Tokyo :
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