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Supervise a team of Analyst Coders that reviews, edits, prioritizes, and analyzes adverse medical events related to medical devices that are submitted on MedWatch forms to the FDA
Analyze, prioritize and organize daily workloads for the team for the many different types of reports
Accountable for ensuring that the contract deliverables are met and/or exceeded on the daily basis
Edit reports to maintain the specified Federal privacy and anonymity guidelines
Analyze daily workloads to identify the product, manufacturer, device problems or malfunctions that contributed to the adverse event of the device
Perform editorial responsibilities to assist and guide the data entry staff in the entry of reports into the FDA database
Monitor performance outcomes and conduct periodic evaluations for direct reports
Coach, counsel and discipline direct reports as needed to achieve favorable performance outcomes
Perform strategic thinking to mitigate problems that could adversely impact the project
Participate in team and management meetings to discuss coding and personnel issues
Participate in special projects as required for the contract
Assist Analyst Coder Team with editing, coding, and entering reports to meet contract deliverables
Maintains staff by interviewing, selecting, orienting, and training employees and developing staff for professional growth
Interact with Administrative, Data Entry, and Quality Control staff to process the reports according to quantity and quality guidelines
Query databases for information needed in the processing of the reports
Develop, implement, and maintain training and standard operating procedures
Serve as the resource person for the resolution of problem reports
Requirements:
Bachelors of Science in Nursing and/or 4 years of progressively more responsible managerial experience
Clinical experience in the different medical specialties
Team player, flexible, and sensitive to time related deadlines
An astute attention to detail and the ability to effectively communicate with direct reports, colleagues, senior management and the FDA client
Ability to adapt and implement changing regulations and procedures
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