Jonathan Douek, PharmD, MS

Regulatory Affairs - Clinical Strategy • Compiled and submitted two IND applications which received Study May Proceed letters • Provide response to questions framework and strategy for FDA requests for information • Create cross-functional timelines for IND authoring and pre-IND meetings • Lead monthly Global Regulatory Team meetings for three Amgen programs • Submission experience include PAS’s, DSUR, PBRER, CSR’s, cross-reference letters, protocol amendments, request for FDA comments, etc. • Advise Evidence Generation Team on regulatory landscape and innovative IND submission strategy

Regulatory Affairs - Advertising and Promotion • Primary regulatory reviewer for legacy products, a recently approved product, and biosimilars • Attend MAC meetings to formulate blackline for material production • Updated and implemented Important Safety Information and Dosing Information following PI updates • Conducted consistent with FDA label analysis for product claims • Coordinated the dissemination of two DHCP letters • Led the development of Amgen Brief Summary of USPI standardization across all products

CDER- Office of Generic Drugs • Accelerated process of guidance issuance for 170 pending draft guidances • Reviewed public comments and provided analysis for draft guidance on generic production of abuse deterrent opioid formulations • Attended advisory committee meetings, Phase III sponsor meetings, Pre-IND safety meetings, and clinical hold calls • Presented research to CDER employees on bioequivalence of narrow therapeutic index drugs

-Contacted doctors and patients -Ensured that each patient receives optimal care -Filled over one thousand prescriptions daily -Compounded capsules, creams, lotions, shampoos, etc.

• Conducted research on drugs that were approved between 2013-2015 with a facilitated review process • Navigated FDA and EMA resources to compile data • Created excel worksheet that consists of data on 74 drugs and over 300 post approval commitments and requirements • Held weekly conferences with the Executive Director of CIRS to discuss research objectives and strategy

-Managed an assembly of 29 members. -Organized events for the student body. -Designated budgets for over 150 clubs.