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.
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.