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Global Labelling Strategy Associate Director

North Potomac, MD 20878

Posted: 02/01/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 539928 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 80-103.14/hr **salary will be commensurate with experience 

Job Description:

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). This individual 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 marketed or pipeline products. The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers.

Minimum Requirements:
  • University 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)
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