Senior Associate, Content Production - Label Updates

About the role:

• 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
• The incumbent will collaborate closely with Regulatory, Content Production, Marketing, and Labelling teams to ensure all promotional and labelling materials are accurate and compliant with the latest regulatory guidance

Key Responsibilities:

Artwork & Content Management

Oversee artwork and content updates for IFUs and Promotional Content Labelling (PCL), ensuring regulatory accuracy, design integrity, and timely execution. Partner with internal design and production teams to maintain compliance and quality standards.

Regulatory Alignment & Label Governance

Lead coordination across Brand Sponsors, MAC, Regulatory, Brand Label coordinators and communicate the impact of label updates (LUDs) on promotional materials, labelling, and. Ensure visibility into FDA timing, brand implications, and readiness plans for Content Production.

Information Stewardship & Communication

Drive consistent information flow on label updates across internal teams, external partners, and vendors, delivering daily insights and weekly summaries to all stakeholders. Maintain rigorous documentation and version control to ensure traceability, transparency, and alignment across internal and external collaborators.

Operational Excellence & Continuous Improvement

Anticipate cross-functional needs, streamline label update workflows, and champion process enhancements that improve efficiency, communication, and regulatory readiness across global and regional teams.

Qualifications & Skills:

Basic Qualifications:

• Bachelors degree and 4+ years of relevant experience in labelling, regulatory affairs, content production, or pharmaceutical marketing operations.

Preferred Qualifications:

• Proven Experience in Regulated Pharmaceutical or Biotechnology Environments.
• Applies deep understanding of compliance-driven operations and documentation standards to ensure quality and audit readiness.
• Comprehensive Knowledge of FDA Labeling Regulations and Promotional Review Processes.
• Demonstrates fluency in regulatory expectations governing labeling accuracy, claims substantiation, and promotional content review.
• Exceptional Organizational Skills and Meticulous Attention to Detail.
• Manages complex deliverables and competing priorities with precision, ensuring accuracy and consistency across all outputs.
• Effective Communication and Cross-Functional Collaboration.
• Engages seamlessly with regulatory, medical, legal, and marketing partners to drive alignment and operational efficiency.
• Advanced Proficiency in Document and Artwork Management Systems.
• Utilizes platforms such as Veeva Vault, PromoMats, or equivalent systems to maintain version control, ensure compliance, and streamline review workflows.

Competencies

• Regulatory and Compliance Acumen
• Demonstrates deep understanding of regulatory frameworks and ensures alignment with global standards and governance requirements.
• Stakeholder Engagement and Cross-Functional Collaboration
• Builds strong partnerships across internal teams, external partners, and vendors to drive alignment and shared accountability.
• Strategic and Clear Communication
• Delivers information with precision, transparency, and consistency to enable informed decision-making at all levels.
• Process Optimization and Workflow Excellence
• Designs, implements, and refines efficient systems that enhance quality, speed, and compliance throughout operational processes.
• Ownership and Execution Accountability
• Follows through commitments with integrity, driving outcomes and maintaining accountability for results.