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Global Labelling Strategy Associate Director

Gaithersburg, MD

Posted: 01/10/2023 Job Number: 22815784

Job Description

GLOBAL LABELLING STRATEGY ASSOCIATE DIRECTOR
GAITHERSBURG, MD
Project 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 Client marketed or pipeline products.
  • The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers.

Required Skills:
  • 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 guidance.
  • 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).

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00081
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Kevin Anderson

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