Experience

Medical Minds, Inc.

• Marketing Services
• 1 - 100 Employee

• Scientific Director

  • 2015 - Present



Julian P. Kaye, PhD

• Principal - Regulatory & Clinical Affairs Documentation and Medical Writing

  • Jan 2010 - Dec 2018

  Critical reviews of medical product development data and the drafting of associated documentation. Production of FDA and other regulatory agency submissions. Other medical writing such as peer-review articles for publication and write-up of conference proceedings for online publication.My accumulated career expertise ranges from original research, R&D, manufacturing, quality, nonclinical, clinical, regulatory, labeling and promotional materials through medical education.My byword, from clinical chemist onward, has always been "GIRFT" = Get It Right First Time.In my role as Scientific Director of Medical Minds Healthcare Communications, Inc, I am able to leverage my broad understanding of medical science, in general, and the clinical-regulatory environment, in particular, for Medical Minds and its wide range of clients.



Documentarium

• Latvia
• Technology, Information and Internet

• Principal

  • Oct 1994 - Jan 2009

  Documentarium provided wide-ranging global regulatory and clinical affairs strategy and medical scientific documentation for healthcare companies. Product areas included drugs, biologics/biotech products, invasive medical devices, imaging devices and contrast agents, in vitro diagnostics and cosmetics (including cosmetic dermatology products).The motto for Documentarium, as shown in its brochure and on the website, was "Knowledge with Integrity; Substance with Style." Documentarium provided wide-ranging global regulatory and clinical affairs strategy and medical scientific documentation for healthcare companies. Product areas included drugs, biologics/biotech products, invasive medical devices, imaging devices and contrast agents, in vitro diagnostics and cosmetics (including cosmetic dermatology products).The motto for Documentarium, as shown in its brochure and on the website, was "Knowledge with Integrity; Substance with Style."



Baxter Healthcare Hyland Division (now Baxter Bioscience)

• Senior Manager, Regulatory Affairs

  • Jan 1991 - May 1994

  Managed a staff of 22 and the departmental budget for the global licensing of new and existing therapeutic biologic products derived from human plasma fractionation or recombinant technology. Project Teams, under my leadership, received Division Awards for an IND (Fibrin Sealant/Fibroseal(R)) and an IND and the corresponding major PLA/ELA (BLA) amendment for Immune Globulin/Gammagard SD(R). Managed a staff of 22 and the departmental budget for the global licensing of new and existing therapeutic biologic products derived from human plasma fractionation or recombinant technology. Project Teams, under my leadership, received Division Awards for an IND (Fibrin Sealant/Fibroseal(R)) and an IND and the corresponding major PLA/ELA (BLA) amendment for Immune Globulin/Gammagard SD(R).



Parexel International Corporation

• Manager, West Coast

  • 1985 - 1991

  Parexel is a major Contract Research Organization.I performed a very broad range of regulatory and clinical affairs services for clients throughout the US, Europe and Japan. In 1985/6, I established the original West Coast office in San Diego and developed new business and serviced clients. Products and projects included drugs, invasive medical devices, imaging devices, in vitro diagnostics, food additives, GRAS products and cosmetics. Parexel is a major Contract Research Organization.I performed a very broad range of regulatory and clinical affairs services for clients throughout the US, Europe and Japan. In 1985/6, I established the original West Coast office in San Diego and developed new business and serviced clients. Products and projects included drugs, invasive medical devices, imaging devices, in vitro diagnostics, food additives, GRAS products and cosmetics.