Michael F. Ryan, Ph.D.
Mike is a medical/regulatory writer and consultant with 25 years of experience. As a director of international clinical development with the world’s largest pharmaceutical company, and Vice President with two clinical research organizations (CROs), he created clinical development programs, and led international Phase III, IIIB and IV trials, analyzed and interpreted results, and prepared regulatory submissions.
He has written clinical development plans, protocols, investigator brochures, CRFs, data management guidelines, clinical/regulatory SOPs, data analyses and presentations, CSRs, labeling, briefing documents and regulatory submissions (INDs, NDAs, ANDAs, including CTD format), journal articles, reviews, training programs for clinical researchers and sales staff, and a computer-based training program for clinical researchers.
As an international director of marketing, he wrote and edited strategic publication plans, journal articles, reviews, symposia, presentations and sales training materials.
Areas of Expertise
- Clinical Development
- Clinical Operations/QA
- Regulatory Writing
- Regulatory Compliance
- Regulatory Submissions
- Pharmaceutical SOPs
- Marketing Communications
- Training
Education
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Postdoctoral Fellowship, Indiana University
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Ph.D. in Biochemistry, University of Louisville Medical School
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B.A. in Chemistry, University of Delaware
Honors
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Sigma Xi National Honor Society
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Phi Lambda Upsilon Honor Society
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Phi Kappa Phi National Honor Society
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NIH Training Grant
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NIH Research Grant
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Writing Awards
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