Cardinal Health

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Senior Coordinator - Regulatory Submissions Operations (Publishing)

at Cardinal Health

Posted: 11/14/2017
Job Status: Full Time
Job Reference #: 20021950-1

Job Description

What Regulatory Sciences and Submissions Operations contributes to Cardinal Health 

Cardinal Health Regulatory Sciences partners with Pharma and Biotech companies to solve complex regulatory challenges and expedite the development process by applying a premier level of expertise and experience to every client engagement.

Regulatory Submissions Operations provide advanced formatting, proofreading, editing and compilation of paper and electronic documents related to the pharmaceutical industry throughout each phase of drug development; electronic processing, publishing and compilation of documents and complete submissions according to regulatory specifications in support of regulatory applications with appropriate agencies.

What is expected of you for success in your role

  • Demonstrates specialized knowledge of preparation, formatting, copy, proof, and assembly of regulatory submissions and controlled documentation
  • Assists publishers with tasks, such as pre-publishing (formatting, bookmarking, hyperlinking) and QC
  • Uses various systems and tools (i.e. Toolbox (formerly referred to as ISI Toolbox), InSight Publisher, eCTDXpress, etc.) for compilation, formatting, assembly, etc.
  • Applies knowledge/skills to a range of activities
  • Completes work assignments with minimal supervision/guidance and high quality

Accountabilities in this role

  • Builds regulatory submissions using specified processes, procedures and systems
  • Creates navigation aids (i.e. bookmarks and hyperlinks) according to specified requirements
  • Adds metadata to regulatory submissions per requirements
  • Produces/publishes regulatory submissions in acceptable, compliant output according to specified guidelines and requirements
  • Incorporates Quality Control (QC) review comments

Preferred Qualifications

  • Intermediate knowledge of MS Word
  • Basic knowledge of MS Excel
  • Intermediate knowledge of Adobe Acrobat
  • Working knowledge of spelling, grammar and punctuation
  • High school diploma or equivalent
  • Minimum of three years in office environment is preferred
  • Minimum of one year in pharmaceutical industry is preferred

Posted 30+ Days Ago

Full time


Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!