Manager - FDA Policy (Leavitt Partners)

Health Management Associates•Washington DC - LP, DC

1d•Onsite

About The Position

The Manager - FDA Policy role at Leavitt Partners is responsible for managing client projects, ensuring they are completed on time, under budget, and within scope. This involves leading project teams, conducting client interactions, and keeping client leads informed of project progress. The role requires an intermediate understanding of the U.S. healthcare system, with expertise in two or three specific topic areas. The ideal candidate will have a bachelor's degree (master's or JD preferred) and approximately five years of experience in health policy, particularly concerning FDA medical product regulation and other life sciences issues. Experience communicating with policymakers and stakeholders, and researching/synthesizing health policy, regulations, and legislation is essential. Specific knowledge of FDA policy, regulations, user fee reauthorization, and medical product development is preferred.

Requirements

Bachelor's degree in political science, public policy, or a related field.
At least 5 years of experience in public health/policy, federal legislation, and other related areas.
Understanding of and about five years of prior experience on health policy issues, including issues related to medical product regulation at FDA and other life sciences issues.
Experience in communicating with policymakers and stakeholders.
Experience researching and synthesizing relevant/current health care related policies, regulations, and legislation.
Demonstrated high collaborative IQ and leadership abilities.
Ability to manage complex projects and project teams.
Ability to deliver high quality, polished work.
Manage up, create value and efficiency for leads.
Professional presentation skills.
Strong written and verbal communication skills.
Excellent research and analysis skills.

Nice To Haves

Master's degree or Juris Doctorate.
Specific subject matter knowledge in FDA policy and regulations, FDA user fee reauthorization process, and medical product development.

Responsibilities

Lead project teams and manage multiple projects.
Be responsible for project outcomes.
Ensure project proposal terms are met including timelines, budgets, and deliverables.
Create and oversee organized project plans and apply principals of project management.
Manage team dynamics, project setbacks, and project plan adjustments.
Implement client feedback and finalize deliverables.
Conduct client interactions and be responsive to client needs.
Keep client lead apprised of progress and client needs.
Apply health care expertise in work product.
All other duties as assigned.