, medical review of clinical trial data and generation of clinical study reports. Additionally, the Sr. Medical Director/Medical... Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global...
direct exposure to a wide spectrum of biometrics activities in support of Clinical Development, Regulatory Agency submissions... and Medical Affairs activities. The incumbent will be responsible for planning and executing a range of biostatistical activities...
for regulatory submissions Experience providing statistical support for Medical Affairs and Market Access activities Experience... and assist in the development and review of other documents required for regulatory submissions and other regulatory processes...
responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational... communication. The position will report to the Associate Director, Risk Management Lead and will be located in the Waltham...