Director / Senior Director, Government Affairs and Policy Avanir Pharmaceuticals
The Director / Senior Director, Government Affairs and Policy (GA&P) is a high-profile, high impact, senior leadership position, and a member of the US Commercial Leadership Team. The Senior Director is responsible for all federal legislative, policy, political, and advocacy strategy and execution for facets of Avanirs business. These areas of responsibility affect all aspects of the business in the short and long term, and include Avanirs external influence and reputation. The Senior Director, Government Affairs and Policy is a recognized and active leader in the biopharmaceutical industry, serving as the Avanir representative with federal government officials, industry trade associations, and influential policy organizations. In addition, this position is the Site Head of the Washington, DC office.
ESSENTIAL JOB FUNCTIONS
The Senior Director, Government Affairs and Policy is a strategic contributor and leader for Avanir responsible for:
Anticipating and predicting changes in the external legislative, regulatory, policy, and political environments in the short, mid and long term; Identifying company opportunity and potential areas of risk in the government legislative, regulatory, policy and political realms;
Creating specific opportunities for Avanirs business and operations in the legislative, regulatory, policy, and political environments; Analyzing the potential impacts of government action, both proactively and reactively, to the business (operational and strategic);
Recommending company positioning, priorities, internal and external strategy, and tactics to the CEO of Avanir and the US Commercial Leadership Team, as it relates to legislation, regulation, policy and politics;
Executing US company strategy and influencing legislation, regulation, policy and politics in support of Avanirs purpose and mission to mitigate risk and maximize opportunity;
Developing and building a proactive, credible Avanir political profile with electoral campaigns at the federal level;
Ensuring that the company is compliant with all federal and state registration and lobbying disclosure laws associated with interactions with US government officials;
Developing and implementing US senior executive engagement strategies;
Contributing to the development of Global Government Affairs and Policy priorities and projects in support of global business objectives; and, Insuring execution and implementation of global policy initiatives in the US.
KEY TASKS & RESPONSIBILITIES
Has responsibility for both internal and external strategic and operational activities (both risk management and opportunity creation) related to government effects on access to and regulation of products (pipeline and marketed) and business operations and practices.
Approve and guide the company strategy relative to government affairs;
Shape an environment that promotes innovation and idea generation; Align the functional teams with Avanirs strategic priorities and ensure coordination and resourcing (including budgets);
Identify opportunities and flag issues that impact the collective U.S. organization;
Lead cross-functional teams on strategic priorities for the organization to ensure cross-functional collaboration, organizational preparedness (strategy and tactics), and execution.
Serve as the primary liaison to the CEO of Avanir, Inc. related to that individuals participation on the PhRMA Board of Directors, BIO Board of Directors and Executive Committee. This includes appropriate preparation and staffing to ensure alignment with Avanir objectives and strategies.
Ensure Government Affairs active collaboration and impact, pre- and post- market, for new product launches in order to ensure as favorable an environment as possible. This includes identifying specific opportunities to support the brands, the business, our customers, and the patients we seek to serve and active leadership on new product launch committees.
Anticipate changes in the government legislative, policy, regulatory and political landscape and advise senior leadership to inform business strategy and planning.
Monitor and analyze external actions and trends in the government sector, and their impact on the private sector, and recommend strategic direction and course of action to senior leadership to support short and long term business planning
Evaluate pending legislation, regulation, and policy for risk and opportunity and business impact on Avanir
Determine the operational and financial impact of legislative proposals and prepare and recommend to the CEO and Commercial Leadership Team appropriate responses, ranging from policy positioning to internal budgeting and structure, internally and externally.
Develop policy positions related to key policy issues and legislation impacting the biopharmaceutical industry and Avanirs business, products, policy, and practices, such as drug safety, comparative effectiveness, and FDA/CMS collaboration and data sharing, in support of business objectives.
This includes legislation/regulation/policy as it relates to science and medicine/product approval/FDA, business practices (e.g. intellectual property, tax), and access/federal payer policy (e.g. coverage and reimbursement)
Government Affairs Department Management Responsibilities
Manage and oversee Washington, DC work, projects, consultants focused on supporting the government affairs plan and tactical implementation of this plan.
Prepare and submit federal and state political (lobbying) and campaign finance compliance disclosures and filings on behalf of Avanir. This includes global coordination and responsibility for reporting interactions with U.S. Government officials in the U.S.
Official representative and public face for Avanir before federal government and stakeholders in the Washington, DC area.
Develop and execute Avanirs strategic and tactical responses to pending legislation/regulation/policy with federal elected officials, regulatory agencies and key policymakers. This includes internal alignment and external engagement with trade associations, relevant third parties, and directly with policymakers.
Responsible for leading Avanirs development and execution of advocacy, education, and public healthcare policy across all of Avanirs business.
Represents the company's position on legislative, policy and regulatory affairs to elected officials and their staffs, and to government officials and staffs in regulatory and other agencies, and crafting and translating Avanirs image and profile in the public healthcare policy arena.
Build solid relationships with federal authorities, regulatory agency heads and key policymakers and enhance Avanirs reputation and image among authorities.
Primary liaison with external stakeholders, patient groups, partners, organizations, and influencers as described above in Main External Interfaces. This includes interactions with the heads of the Washington offices of our competitors, as well as the other large biopharmaceutical companies with a presence in Washington, DC.
7 or more years experience in public policy and government affairs, preferably in the biopharmaceutical industry.
A thorough understanding of legislative processes, proven track record of successful advocacy and winning legislative efforts.
Experience managing relationships with lobbyists and consultants and experience to help shape positive public opinion.
Preference given to individuals with current, established relationships with elected officials, agency heads and policymakers in Washington, DC health care policy and legislative arena and in key state markets (e.g. MA, CA, NY).
Strong business and financial skills. Proven ability to manage significant budget
Strong knowledge of the reimbursement environment for biopharmaceutical products, specifically Medicare and Medicaid related challenges
Widespread understanding and working knowledge of the process, as well as substantive knowledge, of establishing health care policy, particularly related to the coverage and reimbursement decision-making of FDA-approved drugs and biologics
Keen business acumen
Ability to manage multiple, complex issues
High-energy, self-motivated, positive attitude
Clear reputation for ethical conduct
Exemplary performance record
Very Strong: leadership and management skills; written and verbal communication skills, including the ability to make complex concepts conversational; engage in focused dialogue, and demonstrate good listening skills; Ability to present to small and large groups and deal with unexpected questions and challenges while presenting
Ability to drive business results by working with all relevant groups and networks effectively across the Company and cross-functionally with multiple stakeholders
Understands the need for change and drives participation in change efforts.
Flexibility in leading through change, driving through unexpected challenges to deliver on business imperatives. and, strategic thinking
An undergraduate degree is required
Advanced degree (e.g., JD, MBA, MPA, MPP) highly desirable
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