Summary: The RegulatoryAffairs Coordinator II possesses substantial clinical research and regulatoryknowledge and is capable of independent action in the development, applicationand maintenance of all regulatory documentation and activities within the CookChildren's System. This person may rely upon other Senior Regulatory Affairsstaff for guidance, but is capable of managing a project with highest qualitythroughout its lifecycle. The Regulatory Affairs Coordinator II will furtherdevelop their knowledge of regulatory guidelines through independent study andexternal training, as appropriate.
Bachelor's degree in appropriate field (e.g., healthcare,social or health science, etc.) and minimum 5 years relevant clinical research,pharmaceutical or regulatory experience with at least 3 years regulatoryaffairs experience required; or an equivalent combination ofeducation/certification and experience from which comparable knowledge andabilities can be demonstrated.
Computer proficiency in word processing and Excel required.
Knowledge of medical terminology required.
Knowledge of principles of research and federal regulationsrequired.
Detail-oriented with strong organizational skills.
Excellent writing and editing skills.
Good interpersonal and communication skills required.
IRB Administration or Clinical Research certification requiredif used in lieu of education.