Michael Hoffman

Senior Director, Medical Writing and Regulatory Operations

Michael D. Hoffman, M.S., is the Senior Director of Medical Writing & Regulatory Operations for UBC, Biotechnology Solutions. He has over 20 years of experience in pharmaceutical medical/regulatory writing that spans multiple therapeutic area programs from early drug development through post-marketing surveillance. Michael's recent experience included management positions at Parke-Davis Pharmaceutical Research and Pfizer, Inc., where he supervised medical/regulatory writers responsible for clinical study reports, clinical safety and efficacy summary documents, and post-marketing safety summaries. He has worked extensively with Phase 1-2 study reports, regulatory briefing packages, marketing applications (using regional and ICH guidelines, and prepared in the CTD format), and periodic safety update reports, as well as other regulatory documents supporting the safety and efficacy of pre-marketed and marketed compounds. He previously sponsored initiatives to update and improve medical writing processes for clinical study reports and periodic safety summaries, using ICH guidelines and industry benchmarks.

Michael holds a Master's degree in Behavioral Genetics from the University of Missouri and is currently a doctoral candidate in the School of Public Health & Tropical Medicine at Tulane University.

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