Kimberly Frieze, PharmD

Director, Medical Writing

Kimberly Frieze, PharmD, is Director, Medical Writing for Cardinal Health Regulatory Sciences.

Role responsibilities

Dr. Frieze manages a team of 18 medical writers, who provide scientific writing support for clinical and regulatory documents used during the conduct of clinical trials (ie, clinical protocols, investigator brochures and clinical study reports) or to be used as part of regulatory applications such as Investigational New Drug (IND) applications, New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs). 

Professional experience

Dr. Frieze has more than 23 years of experience in the pharmaceutical industry, focusing in the areas of clinical research, regulatory affairs and medical writing for drug and biologic products. Prior to joining Cardinal Health in 2004, Dr. Frieze was part of a medical writing team at for five years. Before Quintiles, she spent seven years with Hoechst Marion Roussel Inc. (formerly Marion Merrell Dow and Marion Laboratories) in various positions within clinical research, regulatory affairs and medical writing. Prior to entering the pharmaceutical industry, Dr. Frieze worked for five years as a clinical pharmacist, with the last two years focusing on clinical oncology.
Dr. Frieze has been involved at various stages of the development process for several FDA-approved compounds, including Anzemet (antiemetic), Lantus (long-acting insulin), Sabril (anti-epilepsy), Allegra (non-sedating antihistamine), Sanctura (overactive bladder/urinary incontinence), Peramavir (antiviral), Vidaza (antineoplastic for myelodysplastic syndrome/AML) and Thalidomide (antineoplastic for multiple myeloma).  

Therapeutic experience

Dr. Frieze has led programs and contributed to the medical writing of NDA documents for products in various therapeutic areas, including cardiovascular, central nervous system, dermatology, endocrinology, gastrointestinal, hematology, infectious disease, neurology, oncology, respiratory, renal, transplantation and urology.

Education

Dr. Frieze is a registered pharmacist in Kansas and a member of the American Medical Writer’s Association (AMWA). She received a doctorate in pharmacy and a bachelor’s degree in pharmacy from the University of Kansas School of Pharmacy.

Areas of Expertise


Medical writing of regulatory applications

FDA meeting requests and information packages

Preparation of clinical protocols

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