Associate Director, Global Labeling

Employer Industry: Pharmaceutical Development

• Salary up to $, plus incentive opportunities
• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
• Generous 401(k) match and flexible time off policies
• Opportunities for professional development, including tuition reimbursement and student loan assistance
• Engaging work environment with a focus on cross‑functional collaboration
• Chance to contribute to high-impact projects in drug labeling and compliance

• Act as Global Labeling Strategy Lead, overseeing the development and maintenance of Company Core Data Sheets (CCDS) and local labeling
• Collaborate with cross‑functional teams to align labeling content and strategy for assigned compounds
• Evaluate risks associated with CCDS updates and communicate implementation strategies
• Manage the development and maintenance of package labeling (artwork) through team collaboration
• Author and review labeling sections for various periodic reports, ensuring compliance and accuracy

• MS/BS in life sciences or a related scientific field
• 6‑8 years of relevant experience in a pharmaceutical regulatory/labeling environment and/or drug development
• Knowledge of scientific principles and regulatory systems pertinent to drug development
• Experience in writing CCDS and local labeling documents for new products
• Strong attention to detail and effective communication skills

• Solid understanding of labeling regulatory requirements and implications of global labeling
• Proven ability to prioritize and manage multiple complex projects simultaneously
• Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems (EDMS)
• Ability to think strategically and recommend innovative solutions
  
  Experience in leading teams and collaborating with diverse stakeholders

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