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Project Manager

North Chicago, Illinois |
Job ID: 102847
Listed on 1/12/2021

KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally served by our 1500+ IT and business consultants. Our industry is growing rapidly, and now is a great time to launch your career with the KellyMitchell team.

Project Manager 

Duties:

  • Chron files, filing and updates
  • Support Annual reports (IND and NDAs; N=70)
  • Support for preparation, follow-up for PADERS, PSURs
  • Minor labeling updates, PSN approvals, represent Regulatory on the Commercial label update team
  • Participate/manage minor supplements and amendments
  • Support  HA correspondence
  • F/U with Orange Book entries
  • Other regulatory projects

Desired Skills/Experience:

  • Bachelor’s degree in scientific field
  • Two years of pharma experience and/or medical devices.
  • Have scientific experience
  • Need to communicate well
  • Work in a cross-functional matrix environment
  • Feel comfortable presenting
  • Tech Savvy Systems database repository experience, need to be able to learn quickly

 

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