Katherine Goodspeed

Background

About Katherine Goodspeed

Diverse background as a teacher, medical librarian & registered nurse; dedicated to health, wellness & life-long learning; passionate about improving the quality, safety & lives of patients through professional work & volunteerism Skills: • Accountable, highly organized, motivated self-starter driving results independently or as part of a team • Agile, flexible, receptive to feedback, strong performer who prioritizes workload managing competing priorities & meeting deadlines in a fast-paced environment for business-critical confidential projects • Excellent presentation, verbal & written skills proactively communicating significant concerns\issues\risks • Highly experienced collaborative coach, leader, liaison, mentor, project manager & trainer for cross-functional teams • Knowledge of drug\device development, CAPA, complaint investigation, FDA Code of Federal Regulations, global safety databases, good clinical practices, pharmacovigilance, policies, regulatory requirements, root cause analysis & standard operating procedures in a regulated environment • Healthcare & information professional understanding complex disease states, complications & treatment outcomes • Medical device & pharmaceutical industry experience in business development, customer service, drug\device adverse event case management, operations, quality assurance, research & development • Meticulous attention to detail with strong analytical, clinical decision making, documentation, literature review, patient care\education & problem-solving skills • Process improvement mindset identifying & proposing innovative efficiency & productivity enhancements • Proficient in applications including Adobe Acrobat, EDCs, EPIC, IRIS, iTrack, Microsoft Office Suite, Oncore, RedCap, Salesforce, SharePoint, Tableau & web-based databases learning new systems & technical solutions quickly