Associate, Regulatory Affairs

Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry.

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts. If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

* Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of product development, including the following: * INDs or international equivalents and amendments * NDAs, BLAs, ANDAs or international equivalents and amendments * Orphan drug applications * Information related to clinical trials including protocols, investigator brochures, and investigator information * Annual Reports * Assist in coordination of meetings with Regulatory Authorities and associated briefing document preparation * Attend relevant functional area and project team meetings, including nonclinical and clinical/regulatory subteams * Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies as necessary * Other duties as assigned

* Bachelor's Degree in Biology, Chemistry or other Life Science * Minimum of one year experience in Regulatory Affairs. * Requires excellent verbal and written communication skills and good attention to detail.