Regulatory Science Innovation Lead

Key Role:

Apply expertise in problem-solving and a health or life-science background to develop solutions to operational and strategic challenges for federal public health agencies. Lead project delivery teams in the design and execution of project plans and analytical approaches to solve challenging, mission-critical client problems. Develop 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 deliver communications of practical solutions to clients in the form of data-driven presentations, briefings, and reports. Support business development objectives through building effective client relationships, providing thought leadership on innovative solutions and service offerings, and contributing to proposal efforts. Manage and develop junior staff on both project and administrative teams.

Basic Qualifications:

  • 8+ years of experience in a professional work environment
  • 2+ years of experience with strategy or management consulting
  • 2+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting
  • 2+ years of experience with project management
  • 1+ years of experience in working with the FDA
  • Knowledge of medical product development and regulatory pathways
  • BA or BS degree

Additional Qualifications:

  • Possession of excellent analytical skills
  • Possession of excellent written and oral communication skills
  • MA or MS degree in life science, engineering, or health-related field or MBA preferred; PhD degree in a life science, engineering, or health-related field a plus
  • Regulatory Affairs Certification (RAC)
  • Project Management Professional (PMP) Certification

We’re an EOE that empowers our people—no matter their race, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or other protected characteristic—to fearlessly drive change.


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