Director, U.S. Public Policy (FDA)

Role Summary

The Director, U.S. Policy will monitor, track, and analyze key U.S. Food and Drug Administration (FDA) public policy issues that could impact AbbVie and the patients we serve. The Director will lead the U.S. Policy & Analytics (USPA) team for all legislative and regulatory policy developments related to FDA, determine impact of new policies with internal stakeholders, and develop advocacy strategies with cross-functional teams. The role includes communicating policy changes to internal stakeholders, developing policy materials, and setting federal policy priorities in partnership with senior leadership.

Responsibilities

• Identify, track, and analyze FDA legislative and regulatory developments that impact AbbVie and its products.
• Work with internal stakeholders to determine how federal legislative and regulatory developments related to FDA reform impact AbbVie and the patients we serve.
• Develop clear and effective communications to ensure that internal AbbVie stakeholders are aware of and understand key issues and developments.
• Provide internal expertise on federal policy and develop policy materials such as talking points, policy papers, and legislative/amendment language, in collaboration with legal, to support FGA, RA, U.S. Strategic Alliances and Legal colleagues in driving adoption of AbbVie priorities and policy positions.
• Develop novel policy ideas/options in collaboration with internal AbbVie stakeholders and ensure that positions are aligned with key business objectives, in collaboration with the key partners.
• Create persuasive materials and compelling messages for the FGA and GPAAS team to utilize in their communications with policymakers and third-party stakeholders.
• Work closely with the GA Therapeutic Area Strategies team and above brand internal colleagues to understand brand strategies and incorporate key insights into policy analyses and development.
• Develop, direct, and manage external analysis, projects, and other initiatives supported by external consultants.
• Ensure alignment with International Policy functions to ensure global consistency of AbbVie‚Äôs public policy positions.
• Represent AbbVie in external policy discussions, as needed, to position AbbVie as an industry thought leader.
• Lead discussion with senior leaders at AbbVie to garner cross functional support for our initiatives including leaders in FGA, RA, GPAAS, Corporate Affairs, and Legal.

Qualifications

• Minimum ten years of experience in progressively more responsible roles.
• Must possess significant experience and deep technical expertise in FDA legislative and regulatory policy.
• Relevant experience in health care with a focus on pharmaceuticals policy required, as well as an understanding of the role of government agencies in health policy at the federal level, and an understanding of the interaction between international, federal and state issues.
• Ability to identify policy opportunities and challenges, to connect policy to commercial business impact, and to develop concise and persuasive public policy positions and other written materials within the context of the political environment.
• Exceptional communicator (verbal, written, presentations). Ability to effectively communicate public policy information and positions to internal and external stakeholders.
• Must be able to work collaboratively with multiple cross-functional peers, handle ambiguity well, and enjoy working in a collegial, yet fast-paced and high performing environment.
• Strong analytical, critical thinking, and organizational skills; strong attention to detail.
• Bachelor's degree in related field such as public policy, health care administration, or political science required. Advance degree preferred (MPH, MBA, JD, MPP, PhD).
• Some domestic travel (15 percent) required.