Job Number: 20014704

Location: Overland Park, KS

Date Posted: 9-26-2017

Job Title: Lead Coordinator, Regulatory Submissions Ops

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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); self review and peer 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

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 and 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
  • Minimum of one year in pharmaceutical industry is beneficial

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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