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MUST have strong technical writing expertise. Previous experience responding and writing responses to FDA on warning letters. MUST have CAPA experience

Client is needing a candidate who is a critical thinker and can create CAPA content that will meet the intent of the response. Looking for 10-15+ years of experience and has direct experience communicating with the FDA, dealing with warning letters and 483s. Technical Writing experience is a MUST have and is the most important aspect of the role.