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Main Heading, LCC offers over 20 years project managing clinical, regulatory, and medical documents in broad therapeutic Phase I-IV FDA/ICH pharmaceutical & medical device areas. Program Management Leader including staff management, document content & format advice, timeline preparation, responsibility allocation, templates, interpretation of data & understanding of statistical analysis, & quality control review. Outstanding writing, communication, interpersonal skills, the ability to work independently & as part of a team, meticulous attention to detail, ability to manage a variety of projects simultaneously, and expert in MS Word, Excel, and PowerPoint.