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Regulatory Clinical Expert

3 weeks ago

Rockville, Minnesota, United States Axle Full time
Key Responsibilities
  • Develop and adhere to relevant SOPs and pharmacy manuals.
  • Review investigator brochures and conduct literature searches to serve as subject matter expert regarding investigational products in ongoing research protocols.
  • Oversee training and mentoring of staff.
  • Manage quality control, completion, and submission of study-related documentation.

You will also be responsible for preparing, submitting, and maintaining Institutional Review Board (IRB), FDA, and/or other regulatory documents and research correspondence as needed.