Delivering on HopeTM

Specialist, Regulatory Document QC


The Regulatory Document Quality Control (QC) Specialist reviews regulatory documents to ensure accuracy, internal consistency, adherence to company standards, and compliance with regulatory guidance.  This position requires a high degree of focus and consistent attention to detail.

ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):

  • Review and revise, if appropriate, regulatory documents including, but not limited to, clinical study protocols, clinical study reports (CSRs), investigator brochures, and integrated clinical summaries.
  • Verify documents for accuracy against source data. Ensure internal consistency and correct grammar, punctuation, and style.
  • Maintain current QC guidance and appendices compilation guidance documents for internal and external vendor use.
  • Coordinate with other departments to compile accurate CSR appendices in compliance with regulatory guidance and ensure consistency across CSRs and programs.


  • Strong verbal and written communication skills is required.
  • Previous QC review experience and familiarity with regulatory documents is required.
  • High degree of focus and consistent attention to detail is required.
  • Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed.


  • Minimum of Bachelor’s degree in a science-related discipline with a minimum of 3 year of relevant QC experience is required.
  • Proficiency in MS Word. Experience with StartingPoint Templates is helpful.

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