This 10-week course will focus on learning how to interpret and organize clinical data and write standard clinical documents in an NDA submission. Also covered is an overview of the NDA’s role in the drug approval process and the guidelines and regulations that dictate the content of an NDA. Lead medical writer responsibilities will be covered as well as hands-on exercises for a key essential clinical NDA submission document. Additional insights into the tools of the trade are also integrated into the course material.