Regulatory Assistant - MOB Linder Research HV - Full Time - Days

Job description

To support the regulatory team in maintaining superior performance in assuring all regulatory tasks and documents are accurate, complete, and properly processed to external and internal contacts; Promotes quality and efficiency in the regulatory process of Lindner Research-Oncology achieving accuracy and completing tasks quickly to facilitate early start-up. Coordinates and performs efforts associated with the preparation of documents or submissions to corporate sponsors, IRB, FDA, or other regulatory agents in a timely and accurate manner. Assures all regulatory packets are complete and any required follow-up or adjustments are performed in a timely manner, allowing department to maintain its position of first initiated or early entry site; independently communicates with the sponsors to define tasks and assure efficiency in completion, representing Lindner Research-Oncology in a professional manner. Maintains current knowledge base of existing and emerging regulations, standards, or guidelines to assure actions are in compliance with standards upon which the department’s regulatory product will be judged. Participates in new employee regulatory awareness training. Makes recommend...