Job Description
Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions.
\n
*Hours will fluctuate
\n
\n
- \n
- 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).
\n
\n
\n
\n
\n
\n