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Responsibilities:

• Excellent employment opportunity for a Global Labelling Strategy Associate Director in the Gaithersburg, MD area. (Remote)
• The Global Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT).
• Leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned Company marketed or pipeline products.
• Contributes to the Development of the labelling group by sharing knowledge and mentoring peers.
  

Experience:

• Bachelor's Degree in Science or related discipline
• 3 to 5 years Pharmaceutical experience, including regulatory experience, preferably working with labelling
• Knowledge of labelling regulations and guidances
• Excellent verbal and written communication skills
• Keen attention to detail and accuracy
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to assimilate clinical and scientific information and present it in a concise manner
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
• Must demonstrate competencies in:
  • Building Relationships (works well across formal and informal networks)
  • Negotiation Skills (good listener; able to build a consensus)
  • Critical Information Seeking (works well across formal and informal networks)
  • Rational Persuasion (able to distil an issue to its key components and suggest solutions)
  • Interpersonal Awareness (aware of how actions affect other people)
• Preferred Background:
  • Experience in Labelling development and/or maintenance
  • Knowledge of major markets Labelling regulations
  • Advanced academic training is highly desirable (PharmD, PhD)