Specialist, Regulatory Document QC

SUMMARY:

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.

QUALIFICATIONS:

  • 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.

EDUCATION and/or EXPERIENCE:

  • 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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