Amanda Maki, PhD

Amanda Maki, PhD

Medical Writer

Amanda Maki, PhD joined Biologics Consulting as a Consultant (Medical Writing) in September 2012.

Amanda joins Biologics Consulting after 4 years as a senior medical writer with Array BioPharma Inc. in Boulder, Colorado. She has experience preparing clinical and regulatory documents for a wide variety of indications from the pre-IND stage through Phase 3. Prior to working at Array BioPharma, Amanda was a medical writer and clinical study manager at the Block Center for Integrative Cancer Care. She was an associate editor for the peer-reviewed journal Integrative Cancer Therapies.

Amanda holds a BS in Botany from Auburn University and a PhD in Pharmacognosy from the University of Illinois at Chicago.

As a Consultant for Medical Writing at Biologics Consulting, Amanda utilizes her medical writing expertise to assist clients in the following areas:

  • Preparation of pre-IND and IND clinical sections and annual reports
  • Writing clinical study protocols, investigator’s brochures, informed consent forms, and clinical study reports
  • Preparation of documents for FDA and Advisory meetings
  • Formatting and structuring clinical documents in accordance with ICH guidelines
  • Preparation of NDA and BLA clinical sections

Education

PhD, Pharmacognosy, University of Illinois at Chicago, Chicago, IL (2005)

BS, Botany, Auburn University, Auburn, AL (1996)