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Global Labeling Strategy Associate Director

North Potomac, MD 20878

Posted: 05/31/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 567985 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 55-66/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 client 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)

**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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