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Submission and Information Specialist

Introduction

Submission and Information Specialist will support formatting of documents and maintenance of these in document management systems as well as data entry activities into regulatory systems and publishing.

Function

  • Format detailed data tables and figures and apply document formats using customized Word templates and ensure adherence to applicable regulatory (e.g., CTD) and the client’s CMC documentation standards
  • Maintain regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint) – Data Entry, Archiving, Tracking
  • Compile regulatory dossiers, format them for publishing and hand over of the dossier to publishing
  • Data entry into global regulatory systems (such as GPRS, Q&A database)
  • Perform QC activities on the deliverables
  • Collaborate with coordinators/product managers
  • Publish CMC change packages in English
  • Ensure overall submission quality
  • Assist in assuring adherence to current processes and standards and support development of new standards and processes
  • Assist technical teams to develop, validate and implement electronic processes and procedures

Requirements

  • A Bachelor Degree or equivalent in Life Sciences
  • Excellent interpersonal and communication skills in English, orally & in written form
  • The candidate should be highly committed to quality even when working under pressure, should have sense of urgency
  • Excellent attention to details
  • Good computing skills – extensive experience in MS Word, Excel, Adobe Acrobat
  • Able to handle multiple project assignments, good time management
  • Flexibility to support changing assignments
  • Ability to work under minimal supervision
  • Ability to work with changing, sometimes high workload

Information

For more information please contact Elena Berlingeri e.berlingeri@tcs.com


Application

For more information please contact Elena Berlingeri e.berlingeri@tcs.com