Tracy Giles

Regulatory Affairs Manager at Premier Consulting

Tracy Giles currently serves as the Regulatory Affairs Manager at Premier Consulting since February 2022, previously holding the position of Regulatory Affairs Associate at Regulatory Professionals from October 2021 to February 2022. Prior experience includes the role of Senior Regulatory Project Manager at OHSU Knight Cancer Institute from April 2018 to October 2021, where responsibilities encompassed overseeing regulatory components for Phase 1 Clinical Trials and managing the study start-up process. Tracy Giles also spent over 13 years at Oregon Health and Science University, initially as a Certified Clinical Research Coordinator focusing on clinical trials in the uveitis and cornea departments and as a Research Assistant II conducting nephrology animal research. Tracy Giles earned a Bachelor of Science in Biochemistry from Azusa Pacific University in 2004.

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Portland, United States

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Premier Consulting

Premier Consulting is a strategic product development and global regulatory consulting brand dedicated to supporting the specialized needs of emerging biotech and specialty pharma companies. These small to midsize companies are the very heart of drug development. Like them, we are dedicated to the patient journey and are driven by the challenges of bringing new life-saving technologies to market. Informed by our Built for Biotech™ core capabilities, we deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, and commercial solutions that are best in class. With a customer-centric culture, we couple efficiency with quality as we guide sponsors every step of the way to commercialization. We tailor development plans to meet the most rigorous global regulatory requirements and deliver results for sponsors - and the patients they serve. Premier Consulting is a business unit of Premier Research.


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51-200

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