Experienced regulatory and medical writer, with a diverse background in the pharmaceutical industry, specializing in clinical study documents, CMC investigations using root cause analysis, quality control data review, drug product and drug substance stability programs, and compendia testing. Excellent communication, strong organization skills, attention to detail, and adept at managing multiple projects at a time.
• Proficient in Microsoft Office Applications (Word, Excel, PowerPoint, Publisher, Visio, OneNote, SharePoint, and Outlook) and Adobe Acrobat DC
• Document review systems including PleaseReview
• Laboratory data management systems including Global Laboratory Information Management (GLIMS)
• Quality system and training platforms including Trackwise/Sentry QMS and Sparta Systems
• Document management systems including Atlas EDMS
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