FDA Principal

Overview

Leavitt Partners, an HMA company, is currently seeking to hire a Principal in our Washington D.C. office with health policy expertise, including specific experience related to FDA regulatory, operational, and/or legislative affairs, to join its growing FDA policy and regulatory practice.

In this role as Principal, you will have the opportunity to shape and grow the FDA Policy and Regulatory practice, building on existing work with established colleagues. As the practice evolves, you will have the opportunity to continuously monitor and evaluate policy and market trends in order to make adjustments and improvements to the practice. As a mission-oriented team, you will be supported in developing policy initiatives and areas of new work that improve health and lives.

The ideal candidate for this role will have a bachelor's degree, with a strong preference for a relevant master's degree or Juris Doctorate. They should also have significant prior experience working for or with the FDA and possess a deep understanding of FDA policies and regulations. They will have expertise in FDA-regulated industries, including experience communicating with FDA staff and researching and studying relevant/current FDA foundational statutes, structure, operations, and related legislative activities.

Job Summary

A Principal is primarily responsible for leading business development by building the Leavitt Partners and HMA brand, sourcing potential clients, and cultivating relationships. Principals also oversee client management as executive sponsors on client projects. Principals are expected to exemplify company values, mentor personnel, and provide thought leadership.

Responsibilities

Work Performed

• Business development
  • Performs business development activities to expand funded work from existing clients or new clients.
  • Develops and maintains a pipeline of future work that demonstrates a likelihood of achieving business development requirements in future periods.
  • Both lead and participate in proposal development and and submission.
• Client management
  • Meets with client to understand requirements.
  • Gathers and organizes information about the issue to be solved or the procedure to be improved.
  • Analyzes data to identify and understand issues to be addressed.
  • Presents findings to clients.
  • Provides advice, implementation plans, and/or suggestions for improvement according to project objectives.
  • Evaluates the client's needs as warranted and adjusts as appropriate.
  • Ensures that all deliverables are high-quality.
• Project management
  • Serves as subject matter expert on projects.
  • Undertakes internal and external short-term or long-term projects to address identified issues and needs.
  • Develop and document tools, analysis, frameworks, tracking tools, road maps, dashboards, and other approaches to manage a variety of large and small projects.
• Leadership
  • Leads and manages teams, provides feedback and development, and advances internal initiatives.
  • Serves as a mentor for other staff members, as requested.
• Performance metrics
  • Ensures performance meets or exceeds HMA expectations in the following areas:
    • Business development.
    • Billable hour target attainment.
    • Manages to budget/project caps established at the outset or assists in negotiating additional fees.
    • Meets quality and operational standards.
    • Completes and submits timesheets, expense reports, revenue forecasts, and other internal reports when due.
    • Participates in and completes all HMA training and development requirements in a timely manner.
    • Participates in internal activities related to business strategies, forecasts, adoption of new technologies/platforms/approaches, and other process improvements.
• All other duties as assigned.

Qualifications

Education/Training

Bachelor's degree in Business Management, Public Health or a related discipline is required. Equivalent work experience in lieu of a bachelor's degree, although not desired, may be determined as acceptable. A master's degree in a related discipline is strongly preferred.

Experience

At least 15 years of progressively increasing prior leadership or management experience in work involving publicly funded healthcare including, but not limited to policy, administration, operations, compliance, research, consulting, and/or evaluation.

Knowledge, Skills and Abilities

• Strong project management skills.
• Solid time management skills.
• Excellent internal and excellent professional networking skills.
• Excellent attention to detail.
• Excellent critical thinking skills.
• Exceptional oral and written communication skills.
• Superior interpersonal skills, including leadership, contribution to culture, and acceptance of accountability.
• Ability to multi-task and adhere to strict deadlines.
• Capable of handling confidential information in a discrete manner.
• Ability to work extended hours when deadlines are approaching.
• Demonstrated thought leadership and deep expertise in more than one critical healthcare area.
• Maintains approach to stay current in trends in areas of subject matter expertise.

EEO

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)