Posted to MedZilla on 2/16/2020

Phaidon International

US-OH, Associate Director-Regulatory Publishing 452431230121-MZ


Our client, a growing Pharmaceutical and Biotech Company is looking for an Associate Director of Regulatory Publishing to join a world renowned team with a growing pipeline.

  • Maintain all regulatory reports, documents and publications are submitted according to ICH, eCTD, and other electronic publishing standards.
  • Ensure quality of published documentation internally and from sponsors.
  • Act as a manager within internal and external software personnel and vendors to ensure proper electronic submission, document control, and validation on other software/systems
  • Maintain libraries of reference including regulatory guidance updates.
  • Act as a Training and Development liaison  to conduct procedural and software L&D Sessions.
  • Support Quality Assurance
  • At least 6 years of clinical research electronic publishing experience, including international experience.
  • Prior experience using publishing tools including Adobe Acrobat Professional, ISI Toolbox, and Extedo eCTD Manager.

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