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Dr. Carol Sable is a Senior Medical Writer with CTD Quality Consulting; she has 10 years of experience as a medical writer in the pharmaceutical industry. Dr. Sable has prepared numerous regulatory documents for pharmaceutical companies including clinical and nonclinical sections of INDs and CTD/NDA applications, clinical study reports, annual updates to INDS, investigator brochures, and clinical trial protocols. In her four years at Schwarz BioSciences, she managed the medical writing activities for the clinical development program for a drug to treat symptoms of neuropathic pain from Phase 2 through submissions to both Europe and the FDA, including authoring the majority of the clinical summary documents. She has also managed the medical writing activities of several other successful CTD/NDA submissions during her time at CROs.
Dr. Sable’s doctoral training was in pharmacology with research emphases in immunology, microbiology, and cancer research. She spent six years in academic research before moving to the pharmaceutical industry. In addition to submission documents, she has also done editing and translating of articles for scientific journals, primarily authored by foreign researchers. |
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