Expertise:
eCTD-Compliant Documents for Regulatory Submissions, areas include Cancer and Oncology, Immune-Mediated and Inflammatory Disease, Cardiovascular, Ophthalmology, Central Nervous System, and Anti-Infectives
Major Product/SVS:
Medical and regulatory writing services for the biopharmaceutical industry
Education Degrees:
Coursework in Biostatistics, Pharmaceutical Education & Research Institute, Inc. (2005); Coursework in Oncologic Development, Pharmaceutical Education & Research Institute, Inc. (2005); Certificate in Clinical Sciences, Pharmaceutical Education & Research Institute, Inc. (2004); Certificate in Training and Human Resource Development, University of California, Berkeley Extension, School of Business & Managementwith Distinction, (1995); Ph.D. in English, University of California, Berkeley (1975); Bachelor of Arts in English, The City College of the City University of New York, with Honors, Magna Cum Laude (1968)
Affiliations Awards:
American Medical Writers Association; Regulatory Affairs Professionals Society; Society for Technical Communication
Industry:
Medical Writing & Consulting
Charity:
Chairwoman, ICH E3 Task Force, Medical Writing Special Interest Area Community, DIA
Number Of Years In Profession:
16
Number Of Years In Current Position:
6
What Does He/She Attribute Success To:
She attributes her success to her meticulous work and concern for clients.
Why did you become involved in your profession or industry?:
She became involved in her profession because her previous experience in sociocultural research and public health led to a interest in global health regulations.
Position Responsibilities and Duties:
Writing documents related to drug development for the biopharmaceutical industry; Particuarly eCTD-compliant documents for drug submissions; Overseeing the operations of Illyria Consulting Group, Inc.; Supervising copy-editors, and other medical and regulatory writers
Education Certifications:
Core Credential Certificate in Editing and Writing, American Medical Writers Association (2002); Core Credential Certificate in Pharmaceuticals, American Medical Writers Association (1998)
Awards/Honors:
The Phi Beta Kappa Society
Where Will You Be In 5 Years:
In five years, Dr. Katz hopes Illyria Consulting Group is still thriving and recognized as a leader in the field of medical and regulatory writing communications.