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R&D Clinical Eds

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 Clinical eDS

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

The R&D Clinical eDS role at Sanofi is a part of the Clinical Electronic Document Management (CEDM) team under CSO-Clinical Documentation. The primary responsibilities include ensuring submission-readiness of clinical documents, formatting validation, and compilation of non-complex documents in Sanofi’s official electronic Document Management System (eDMS). This role requires close collaboration with cross-functional global teams and the ability to adapt to technological innovations, including AI.


Main Responsibilities

Document Management

  • Validate format and submission-readiness of clinical documents per Sanofi SOPs and guidance.

  • Ensure proper naming conventions, metadata, and document navigation within eDMS.

  • Set internal links and electronically approve all clinical documents within eDMS.

  • Compile and publish non-complex documents and assist with Clinical Study Reports (CSR) preparation.

Project Support

  • Review timelines (Microplans) from Medical Writers and confirm feasibility.

  • Track and follow up on the availability and formatting of appendices.

  • Assemble and validate documents in required order for submissions.

Collaboration

  • Work with teams across Regulatory, Pharmacology, Statistics, Clinical, and Project Leadership functions.

  • Provide support in an evolving tech-driven environment; contribute to process improvements.


About You

Work Conditions

  • Flexibility to work 3 PM – 11 PM IST to align with North America-based teams.

Education

  • Bachelor’s degree in life sciences or related field (preferred).

Experience

  • Experience in the pharmaceutical or related industry preferred.

  • Background in document formatting, submission dossiers, and document management systems (advantageous).

  • Familiarity or experience with Artificial Intelligence is desirable.

Skills

  • Strong command of English (verbal and written).

  • High attention to detail, multitasking ability, and self-motivation.

  • Excellent interpersonal, organizational, and communication skills.

  • Tech-savvy and adaptable to new tools and systems.

  • Proficient in MS Office 365, especially MS Word (advanced formatting capabilities).

Preferred Tools

  • Experience with eDMS (e.g., Vault RIM), Acrobat (ISI Toolbox), and publishing tools (preferred but not mandatory).


Sanofi’s Culture & Commitment

Sanofi embraces diversity, equity, and inclusion, striving to create better outcomes through collaborative innovation. The company provides equal opportunities to all individuals regardless of race, religion, gender, nationality, or background.