Senior Director, Government Affairs & Policy
The Senior Director, Government Affairs and Policy (GA&P) is a high-profile, high impact, senior leadership position, and a member of the Avanir Leadership Committee. The Senior Director is responsible for all federal legislative, reimbursement and advocacy strategy and execution for facets of Avanir’s business. These areas of responsibility affect all aspects of the business in the short and long term and include Avanir’s 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.
Essential Job Functions:
- Anticipate changes in the legislative, regulatory, policy, and political environments in the short, mid and long term, and advise senior leadership to inform business strategy and planning;
- Evaluate pending legislation, regulation, and policy for risk and opportunity and business impact on Avanir;
- Execute strategy and influence legislation, regulation, policy and politics in support of Avanir’s purpose and mission to mitigate risk and maximize opportunity;
- Ensure Avanir is compliant with all federal and state registration and lobbying disclosure laws associated with interactions with US government officials;
- 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;
- Develop policy positions related to key policy issues and legislation impacting the pharmaceutical industry and Avanir’s business, products, policies, and practices, such as drug safety, comparative effectiveness, and FDA/CMS collaboration and data sharing, in support of business objectives.
MAIN INTERFACE INTERNALLY:
- Head of Government Affairs
- Chief Commercial Officer
- Legal Department
- Head of IP
- VP Clinical Development & Scientific Strategy
MAIN INTERFACE EXTERNALLY:
- US Federal Government – e.g., US Congress, Department of Health and Human Services (including Centers for Medicare and Medicaid Services (CMS)), Agency for Health Care Research and Quality (AHRQ), and senior appointed officials at the Food and Drug Administration (FDA)
- Quasi-governmental policy setting organizations – e.g., MedPAC, US Pharmacopeia, Institute of Medicine, etc.
- Industry trade associations
- Key Federal policy organizations
- Policy and lobbying consultants
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Bachelor’s degree required, preferably in English, communications, journalism, public relations or related field.
- Advanced degree (e.g., JD, MBA, MPA, MPP) preferred.
- 18+ years of relevant experience in public policy and government affairs, preferably in the biopharmaceutical industry or pharmaceutical industry, including 10+ years of management experience. Or 12+ years of related experience with an advanced degree.
- 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 helping to shape positive public opinion.
- Strong business and financial skills. Proven ability to manage significant budget.
- Strong knowledge of the reimbursement environment for pharmaceutical products, specifically Medicare and Medicaid related challenges.
- Ability to manage multiple, complex issues
- High-energy, self-motivated, positive attitude
- Clear reputation for ethical conduct
- Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en
Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries
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Job posted: 2020-09-11