Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions.*Hours will fluctuate 10 years Regulatory Writing experience for pharmaceutical industry. Lead author experience required Experience with NDA modules and higher level module writing as well as CSRs, IBs, protocols, etc. Phase II/III experience Neuroscience or CNS related drug indication experience Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH).
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Level
Senior L5
Location
Dearing, KS
Occupation
Regulatory Affairs Specialists
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing