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The Sr. Associate, Content Production – Label Updates is responsible for coordinating and managing activities related to Label Update development (LUD) across Amgen brands and devices. This role ensures timely communication, alignment, and execution of content and artwork changes impacted by FDA label updates.
Job Responsibility:
Oversee artwork and content updates for IFUs and Promotional Content Labelling (PCL), ensuring regulatory accuracy, design integrity, and timely execution
Lead coordination across Brand Sponsors, MAC, Regulatory, Brand Label coordinators and communicate the impact of label updates (LUDs) on promotional materials
Drive consistent information flow on label updates across internal teams, external partners, and vendors
Anticipate cross-functional needs, streamline label update workflows, and champion process enhancements
Requirements:
Bachelor’s degree and 4+ years of relevant experience in labelling, regulatory affairs, content production, or pharmaceutical marketing operations
Proven Experience in Regulated Pharmaceutical or Biotechnology Environments
Comprehensive Knowledge of FDA Labeling Regulations and Promotional Review Processes
Exceptional Organizational Skills and Meticulous Attention to Detail
Effective Communication and Cross-Functional Collaboration
Advanced Proficiency in Document and Artwork Management Systems