The Weinberg Group Adds Additional Medical Device, Clinical Development, & ANDA Experts to Team as Company Continues to Grow
WASHINGTON, DC – OCTOBER 3, 2018 – The leading FDA consultancy, The Weinberg Group Inc., is growing. In addition to people, The Weinberg Group has also expanded its capabilities. Building upon its role as the most science minded of all firms in its space, the company welcomed the following senior-level staff members to its team, thus expanding its ANDA, medical device, and clinical development capabilities.
Bryce Whited, Ph.D.
Vice President, Medical Devices
Dr. Whited is an expert in all phases of the development, approval, and marketing of medical devices and combination products. He has extensive hands-on experience with U.S. regulatory submissions (IDE, PMA, 510(k), de novo, and HUD/HDE), change control, risk management, nonclinical testing, and clinical trial design. Prior to joining The Weinberg Group, he was a lead scientific reviewer at the FDA, and held senior regulatory positions at Biotronik and Contego Medical.
Chad Oh, M.D.
Vice President, Clinical Development
Dr. Oh consults on the clinical and regulatory development of vaccines, biologics and small molecules. He has handled global development programs across various therapeutic areas, including autoimmune diseases, respiratory diseases, infectious diseases, cancer, CNS, and rare/orphan diseases. Dr. Oh has effectively managed multiple submissions to U.S., European, and Asian regulatory authorities. His vast knowledge acquired through his medical, academic, and industry posts provides Dr. Oh with the unique expertise to guide the company’s clients in all phases of clinical development as well as the implementation of successful regulatory strategies.
Rona LeBlanc-Rivera, Ph.D.
Dr. LeBlanc-Rivera has over 18 years of Pharmaceutical experience with specific concentration in generics, handling product launches, market re-introductions, life cycle maintenance and drug shortage mitigation strategies. She has successfully managed the compilation, review, and maintenance of ANDA, DMF, and NDA submissions. Her previous experience as an FDA CMC reviewer (biologics and small molecule generic drugs) has provided her with the knowledge to minimize the number of FDA deficiencies received by a company. Dr. LeBlanc-Rivera’s role within The Weinberg Group includes providing regulatory support to its clients.
The company is still working to fill a number of positions and invites interested candidates to submit their CV and cover letter. Additional information and a list of current openings is available on the company’s website.
About The Weinberg Group Inc: The Weinberg Group is the world’s leading FDA consultancy, working with pharmaceutical, biotechnology, and medical device companies on FDA, regulatory, quality and compliance, and company-related matters for over 35 years. Founded in 1983, The Weinberg Group has helped countless companies achieve successful interactions with the FDA.