Our Client is a large Boston area biotech with multiple products in the market. They are a stable company with a global presence and a rich company culture of excellence and advancement. Currently they have a strong product pipeline and continually strive to be on the forefront of innovation.

This position is a 12 month contract with the possibility of an extension and compensation of $50/hr+ (DOE). In this position you will have a chance to work with a strong team of SAS Programmers and Biostatisticians as you compile the e-submission components that will be turned over to the regulatory group. Also you will be over creating data definition specs. 

To be considered for this position you must meet the following:

· FDA submission experience

· 4yrs+ pharmaceutical experience

· Background with creating data definition specs

· Experience working with SAS Programmers, Biostatisticians , and Regulatory professionals.

· Familiar with electronic submission components

For confidential consideration, please respond electronically noting the job title and refcode in the subject line.