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Electronic Document Specialist

New Jersey All, New Jersey

Post Date: 07/12/2017 Job ID: JN -072017-19521 Industry: Clinical Operations - Clinical

The eDS is the Subject Matter Expert (SME) responsible for regulatory compliance related to navigation, format, and document structure. This role works in close collaboration with Sanofi teams responsible for the operational delivery of clinical documents.
At a project level, the eDS ensures the submission-ready format of clinical documents prepared in the Electronic Document Management System (eDMS). He/She compiles documents and creates navigation to constitute the clinical part of the Electronic Record submitted to health authorities.

The eDS is the point of contact for training and oversight of vendors working on Clinical Documents. He/She is the point of contact with vendors for resolution of operational delivery issues, escalation of format issues, and working with internal teams to prioritize when needed.

Skills:

eDS activities will be performed by individuals, as needed, to ensure format output of clinical documents produced by clinical documentation

  • Oversight of vendor activities in their area of expertise; validating deliverables to ensure compliance, and delivering feedback to the vendors

Maintain trackers to organize and track deliverables

Education:
  • Subject matter expert on different areas within Clinical Documentation with expertise in at least one area (CEDM, publishing)
  • Strong English language skills; excellent written and verbal communication skills
  • Strong organization skills and ability to work transversally and cross culturally
  • Ability to work under pressure (i.e., due to constrained timelines)
  • Operational experience of MS Office applications and eDMS

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