Manager to Director Regulatory Labeling (remote potential for right candidate)

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.

* Preparation of labeling content based on source documents such as Clinical Study Reports (CSRs), regulatory requirements and other reference documents * Review worldwide labeling against the core company safety information and facilitate and track implementation of core labeling changes * Document control and distribution of product labels including drafting initial documents, annotations, and prepare final labeling * Project management role of logistical activities and delivering labeling documents within agreed timeframes including preparing meeting minutes for labeling teams, ensuring proper document control and management of labeling project files in LiveLink * Facilitate and lead the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions * Provide and maintain background documents outlining the purpose and justifications for labeling change * Facilitate senior management reviews of labeling documents for submission * Ensure content of labeling text is verified and maintain version control * Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times * Maintain knowledge of current rules and regulations governing global labeling activities * Assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content * Manage translations of labeling content into local languages (includes assessment of back translations and reconciliation of potential errors) * Verify approved labeling is accurate based on the last version submitted to Agency. Communicate to Director of Labeling any discrepancies and recommend a plan of action * Approve final labeling artwork in the Track Wise (change control) system for final printing and implementation * Research local regulations and guidance to assess labeling requirements

* Experienced in Regulatory Labeling (US and/or EU minimally, international a plus) * Written drug product labeling content * Proficient with Word, Excel and Adobe Acrobat. MS Project a plus * Success leading cross functional teams from multiple locations * Science or medical education a requirement