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).
Matching similar jobs
Level
Senior L5
Location
Brooklyn, NY
Occupation
Writers and Authors
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing