Regulatory Health Consultant, Senior

Key Role:

Apply expertise in problem solving and health or life science to develop solutions to operational and strategic challenges for federal public health agencies. Work with project delivery teams to provide leadership and analytical support for the execution of project approaches and development of deliverables and strategic recommendations to drive organizational improvements in business processes, program operations, strategic planning, policy effectiveness, and decision-making. Perform independent quantitative and qualitative data collection and analysis methods to derive insights on client issues, evaluate trends, and assess potential solutions. Develop and support or lead communications of practical solutions to clients in the form of data-driven presentations, briefings, and reports. Support business development objectives by contributing to proposals and marketing efforts.

Basic Qualifications:

-6+ years of experience in a professional work environment
-Knowledge of medical product development and regulatory pathways

-Knowledge of analytics
-BA or BS degree

Additional Qualifications:

-1+ years of experience in working with the FDA
-1+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting
-1+ years of experience with strategy or management consulting

-Ability to work in a team-based or project environment
-Ability to lead projects or tasks
-Possession of excellent oral and written communication skills

-MBA, MA, or MS degree in Life Science, Engineering, or a Health-related field preferred; PhD in a Life Science, Engineering, or Health-related field a plus
-Lean Six Sigma Certification
-Regulatory Affairs Certification (RAC)
-Project Management Professional (PMP) Certification

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