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Think and Grow Rich
Min 15 yrs required
Sep 05, 2022
Dec 19, 2022
May 21, 2022
Vice President, Public Policy, General Counsel Global Product and Marketing
Duties: The candidate will manage dedicated public affairs professionals in each of Align’s main regions and provide guidance and recommendations to other Align departments on policies and requirements affecting commercial operations and will ensure compliance with accepted practices. Develop and implement a cohesive and impactful public affairs strategy for Align by anticipating and identifying critical public policy, political, regulatory, and legislative issues and developments that influence the environment in which the Company operates and that may impact its business. Develop market-specific intelligence to identify risks arising from the external policy environment and those that may be posed by Company plans and initiatives in the context of the broader policy environment. Advise Company leadership and propose strategies to either avert or mitigate risks. Assess emerging political, regulatory and policy trends to inform Align’s long-range business plan and planning process. Develop and implement highly effective strategies, policies, and operating plans to support the Company’s business goals. Collaborate with legal, regulatory, clinical, corporate communications, marketing, and commercial colleagues to appropriately position Company strategies and operational goals to external policy constituencies and influencers. Leverage synergies between existing externally facing programs (Align University Program, Align CSR/philanthropy) to increase the impact of ongoing work. Assess and develop novel strategies around public and private payor reimbursement and managed market access. Manage and oversee a dedicated internal Public Affairs team, the Company’s Global Policy Council, and the Company’s external lobbying and policy consultants. Oversee legislative and policy engagement with governments and administrations; relevant ministries, departments, and regulatory bodies; trade and professional bodies in all markets in which Align operates. Assess, shape/develop and enact legislation and regulations that support the Company’s policies while working to level the competitive playing field. Coordinate and manage the Company’s advocacy initiatives and relationships with cross-national trade and professional associations, dental schools, patient and consumer advocacy groups, and various policy and public affairs coalitions such as the World Health Organization; European Oral Health Foundation, Bureau Européen des Unions de Consommateurs (BEUC), etc. Advocate for inclusion of clear aligner education in undergraduate, graduate and continuing education academic curricula. Proactively ensure compliance with all applicable registration, reporting and other legal requirements for Align’s Public Affairs program. Work with product counsels to establish and refine external advocacy positions formed around key products or topics. Serve as head legal counsel to our global product and marketing organization: act as legal leader on the Global Marketing and Product Leadership Team and be a strategic partner for our EVP and Chief Marketing Officer. Provide advice and legal counsel and oversee the legal team supporting Align’s global product and marketing function with a particular emphasis on the Food, Drug, and Cosmetic Act, FDA regulations, and FTC laws and regulations. Manage dedicated legal professionals providing advice to all global product and marketing teams including claims committee, medical affairs, product/product roadmap development, clinical operations, Quality Assurance/ Regulatory Affairs, managed markets and reimbursement policies and programs, trademarks, and trademark enforcement. Advice on product leadership of key launch risk and ensure business teams take account of relevant risks to ensure products meet acceptable standards of compliance and risk. Analyze and interpret new regulations and FDA and FTC guidance documents as well as monitor and determine the impact of Office of Prescription Drug Promotion or Advertising (OPDP) and Advertising and Promotion Labeling Branch (APLB) correspondence and enforcement actions. Continually monitor the regulatory environment, interpret new regulations, guidance documents, and enforcement activities/trends and evaluate the impact on the business. Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate. Monitor competitor advertising to keep abreast of market promotional and advertising strategies and assess potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate. Leverage strong knowledge of FDA and FTC requirements, especially as related to claims, claims substantiation, advertising, and promotions. Assist in managing, pursuing, and responding to regulatory agency investigations and administrative actions, with particular emphasis on FDA, FTC, NAD, state agencies, state attorneys general and other issues. Be responsible for communicating brand protection and anti-piracy policy and vision, both internally and externally. Oversee the development and maintainance of a comprehensive brand protection and anti-piracy program, including setting the strategy and priorities, and defining and documenting strategic goals and objectives. Work closely with product, marketing, and engineering teams, lead the global trademark, brand protection and piracy legal teams to develop Align policies, tools, resources, and processes to protect Align brands and prevent piracy. Drive efficient and effective anti-piracy solutions that work at scale, including implementing online monitoring tools, developing communication and educational resources, and streamlining the takedown process. Develop outreach, education and awareness strategy of brand protection and anti-piracy issues externally and internally. Develop KPIs that measure the effectiveness of the brand protection and anti-piracy activities, track and analyze programs to optimize overall results, and share best practices across regions. Drive thought leadership of brand protection anti-piracy solutions through analytical deep dives and lead the discussion to ensure effective prioritization of trademark, brand, and piracy initiatives. Identify challenges and find creative solutions to prevent and manage risks. Provide support to the Chief Legal Officer, Regional General Counsels and other members of the legal team on issues related to global poduct and marketing initiatives as requested by the CLO. Periodically report to the Executive Management Committee and/or Board of Directors on issues Effectively develop and manage budgets for the function. Proactively manage development, goals, objectives and performance of internal staff.
Qualification and ExperienceQualifications: The candidate should have JD from an accredited school is required. A minimum of 15 years of combined international legal and public policy/government affairs experience including experience in the healthcare sector (consumer health, medical device, and/or pharmaceutical). Demonstrated skill in developing political and legal strategies that advance business and corporate strategies and ability to execute those strategies. Proven ability to successfully lead a public affairs/policy program and provide legal advice and guidance to marketing and product organizations in a global multinational. Experience with corporate legal and public affairs department staff management, including legal operations, external law firm and consultant management, budget management, team training programs, and talent management and recruitment. Demonstrated leadership experience over high-performing government affairs and legal teams operating in diverse geographies and confidence in delegation of management of key strategies and functions. A proven leader, with excellent business judgment. Excellent interpersonal skills as demonstrated through strong cross-functional organizational relationships and trusted partnerships with external stakeholders. Superb written and oral communication skills with high attention to detail and experience and comfort before senior political, trade association, and corporate leaders and Boards of Directors. Ability to lead and drive high-performance teams. Ability to identify and establish productive contacts and alliances in key state legislatures, the U.S. Congress, executive branch agencies, trade, and professional associations, and advocacy organizations. Familiarity with laws and regulations impacting medical device approval and use, healthcare provider and consumer advertising, and policy concerning areas such as cyber security, intellectual property protection, trade, and tax policy, and patient privacy. Ability to anticipate and identify emerging political and health care trends. Ability to bring structure to ambiguity, cultivate collaborative client relationships, and demonstrate resilience under pressure in a geographically diverse, agile, and high-growth organization. A strong commitment to customer service with a high sense of urgency and accountability. Ability to gain trust as well as build productive relationships and influence key leaders and multiple stakeholders across the organization at all levels.
Hiring CoordinatorAlign Technology, Inc.2560 Orchard ParkwaySan Jose, CA 95131Phone: 408-470-1000Fax: 408-470-1010
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