Work Experience

Experience since 1995 designing, writing, producing, and reviewing clinical trial protocols, investigational new drug (IND) applications and annual reports, investigational drug brochures, clinical/statistical study reports, integrated summaries and other new drug application (NDA) components, and packages for sponsor meetings with Food and Drug Administration (FDA) personnel. Also served as regulatory project leader and FDA liaison. Projects have included development work with pharmaceuticals, biologics, and devices, as well as with combination products (biologic/device, pharmaceutical/device).

Writing experience also includes peer reviewed scientific journal articles for pharmaceutical companies, an industry based research institute, and academic laboratories; research protocols and grant proposals; toxicology monographs; and progress reports for both technical and general public audiences.

Twelve additional years of experience in designing and conducting basic scientific research in biochemistry and toxicology has contributed to my expertise in problem identification, solution formulation, and data analysis of both nonclinical and clinical data. Doctoral and post-doctoral research included work on molecular carcinogenity, genetic toxicology, and genetics of hepatic detoxification pathways.

Extensive public speaking experience to both professional and lay audiences including scientific presentations, workshop facilitation, and training sessions on topics related to medical writing and Common Technical Document process improvement.