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R&D Senior Eds Specialist

0-2 years
Not Disclosed
10 April 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: R&D Senior eDS Specialist

Location: Hyderabad
Job Type: Full-time, Permanent
Company: Sanofi
Department: Clinical Electronic Document Management (CEDM), CSO-Clinical Documentation


About the Job

As an R&D Senior eDS Specialist, you will play a pivotal role within Sanofi’s Clinical Electronic Document Management team. You will ensure the format and submission-readiness of clinical documents using Sanofi’s electronic Document Management System (eDMS), compile non-complex documents, and support submission processes to health authorities. The position also involves collaboration with cross-functional teams and adapting to emerging technologies, including AI.


Main Responsibilities

Document Validation & Publishing

  • Validate format and submission-readiness of clinical documents as per SOPs and guidelines.

  • Publish and compile clinical documents (especially non-complex ones) and perform internal document linking.

  • Create and maintain documents in eDMS, ensuring correct naming conventions and metadata.

  • Perform electronic approvals for clinical documents within eDMS.

Project Support

  • Review and confirm publishing timelines (Microplans) in collaboration with Medical Writers.

  • Track availability of appendices and follow up with contributors.

  • Validate formatting and submission-readiness of appendices and final compilations.

Technology & Innovation

  • Function as an expert user of required software/tools; suggest improvements and propose tech solutions.

  • Perform user testing for new digital tools and applications as required.

  • Embrace AI and digital tools to support documentation processes.

Leadership & Collaboration

  • Lead and collaborate on projects with global English-speaking teams.

  • Train team members and stakeholders as a Subject Matter Expert (SME).

  • Identify and implement opportunities for process improvement.

  • Manage priorities and requests to meet business timelines.


About You

Experience

  • Preferred: Pharmaceutical or related industry experience

  • Advantageous: Document management, clinical submission dossiers, or AI experience

  • Desirable: Experience formatting electronic documents

Education

  • Bachelor's degree in Life Sciences or related field (preferred)

Skills

  • Excellent communication (written and verbal), interpersonal, and organizational skills

  • High attention to detail and strong time management

  • Adaptable, proactive, responsible, and collaborative mindset

  • Capable of working in a fast-paced, multicultural matrix environment

Technical Proficiency

  • Strong command of MS Office 365 (especially advanced MS Word)

  • Knowledge of eDMS systems (e.g., Vault RIM), Acrobat (ISI Toolbox), and publishing tools (preferred)

  • Strong digital affinity and openness to learning new tools

Languages

  • Excellent English (spoken and written)


Company Values

Sanofi values diversity and equal opportunity. We believe that progress comes from people working together, exploring new ideas, and pushing boundaries to achieve the extraordinary.