WASHINGTON, DC – OCTOBER 3, 2018 – The Weinberg Group (now ProPharma Group), is growing. In addition to people, the company 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.
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 company, he was a lead scientific reviewer at the FDA, and held senior regulatory positions at Biotronik and Contego Medical.
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.
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 company 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.
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