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- Collaborate closely with Global Regulatory Team Leader to align labeling strategy with regulatory objectives, providing expertise in labeling regulations and competitor analyses.
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- Identify opportunities to influence regulatory policy and climate regarding labeling content.
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- Comprehensive knowledge of Global Labeling Guidances, drug development, and commercialization of prescription medicines.
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- Previous experience engaging with Health Authorities bodies.
- Demonstrated ability to develop strong working relationships across diverse teams within a global environment.
- Proven experience in managing high to medium complex projects.
- Excellent project management, verbal, and written communication skills.
- Strong attention to detail and accuracy, coupled with strategic thinking ability.
- Proficiency in assimilating clinical and scientific information and translating it into labeling content.
- Creative thinking and strong problem-solving skills.
- Effective time management skills.
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AI Developer - Summit, United States - NavitsPartners
Description
Position: AI Developer
Location: Short Hills, NJ
Duration: 1 Year
Overview:
The Associate Director, Global Labeling Strategy for Early Asset holds the primary accountability for the creation and updates of critical labeling documents, including Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI), and EU Summary of Product Characteristics (SmPC) for products registered via centralized, Mutual Recognition, or Decentralized Procedure. This pivotal role drives the labeling strategy in alignment with regulatory, commercial, and development strategies, ensuring compliance and efficacy throughout the product lifecycle.
Key Responsibilities:
Qualifications:
Comments for Suppliers: N/A
