Premier Consulting
Michelle Coughlin is a highly experienced Senior Medical Writer and Editor currently at Premier Consulting, where responsibilities include ensuring quality and compliance for FDA and global regulatory submissions. Previous roles at Camargo and MedStar Health involved leading quality control processes and performing expedited reviews for clinical studies. Michelle's extensive background also includes serving as Vice Chair and Scientific Board Member at Schulman IRB, where leadership in regulatory reviews and the implementation of efficiency improvements was key. Academic qualifications include a Master of Science in Medical Genetics from the University of Cincinnati and a Bachelor of Science in Bacteriology and English Literature from the University of Wisconsin-Madison.
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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.