Senior Medical Writer Job at Hydrogen Group, New York, NY

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  • Hydrogen Group
  • New York, NY

Job Description

Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions.

  • 10 years Regulatory Writing experience for pharmaceutical industry.
  • Experience with NDA modules and higher level module writing as well as CSRs, IBs, protocols, etc.
  • Safety module writing experience/Safety Evaluation Reports experience
  • Neuroscience or CNS related drug indication experience
  • Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired.

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