Labeling Operations Manager, Manager

Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. The LOM will provide operational support:

• Consolidate labeling versions.
• Consolidate comments from Labeling reviewers and Regulatory Authorities.
• Prepare comparison tables for labeling team discussions.
  
  Bachelor's degree in a science or life sciences preferred or equivalent practical experience.
Experience:
• Demonstrates a solid understanding and extensive experience in a regulated environment; Strong pharmaceutical labeling experience, required.
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
Project Management capability and organizational skills:
• Ability to assess and manage project timelines.
• Ability to multi-task, prioritize and manage multiple projects.
• Ability to identify and resolve problems in a proactive manner.
• Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
Technical Skills
• Ability to apply labeling regulatory guidance on formatting requirements.
• High attention to detail.
• Ability to consolidate comments from multiple sources.