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Primary Review Director; Promotional Regulatory Affairs job - Cascades Tissue Group-TN, Inc. - Wilmington, Delaware
| Company Name | Cascades Tissue Group-TN, Inc. jobs |
| Position Type | Full-Time |
| Job Location | Wilmington, Delaware DE |
| Job Posted | September 26, 2008 |
| Experience | 5-10 years experience |
| Source | hotjobs.yahoo.com |
Primary Review Director; Promotional Regulatory Affairs 
Minimum Requirements Skills and Competencies · Advanced degree in pharmacy, pharmacology or ... affairs with at least 5 years in review and approval of product promotional material or 15+ years ... experience · Comprehensive understanding of relevant promotional regulations and guidances including labeling, product promotion and scientist exchange of information regulations · Comprehensive understanding of all AstraZeneca Business Policies pertaining to sales and marketing · Working understanding of drug development process · Significant experience (5 years) interacting with FDA/DDMAC and an understanding of drug development process · Demonstrated ability to review product promotional material, identify false and misleading information, and propose alternate solutions to mitigate risk · Demonstrated competency in leading and facilitating team meetings and managing and resolving conflict in cross-functional teams of attorneys, clinical physicians and commercial staff · Excellent verbal, written and communication skills and ability to write and articulate scientific arguments in a persuasive manner · Experience in managing and directing staff · Demonstrated experience in project management ...
