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Associate Director Regulatory Operations (Clinical Documentation)

Company: Hamlyn Williams
Location: Palo Alto
Posted on: August 2, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Collaborates with colleagues to efficiently produce high-quality, strategically aligned clinical/regulatory documents supporting the regulatory requirements of a clinical development program
  • Process and publish eCTD documents for proper submission
  • Development, management, and oversight of SOPs
  • Lead the establishment and maintenance of a global Regulatory Information Management systems and database
  • Review the QC of submissions documentation
  • BA/BS or equivalent experience, advanced degree preferred
  • At least 6 years with demonstrated experience in clinical-document production and--experience in document production in the pharmaceutical industry,
  • Experience with filing eINDs

Keywords: Hamlyn Williams, Palo Alto , Associate Director Regulatory Operations (Clinical Documentation), Executive , Palo Alto, California

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