More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
Please note that the requirements specified in this posting are the basic qualifications required for the (Senior Counsel); however, job title will be dependent on the candidate s level of experience in those requirements.
Provide practical, timely, quality legal services to help the company meet its business objectives through deep understanding and compliance with laws, rules and regulations applicable to the company's businesses. This position may be assigned to a sub-specialty area within the Law Department.
- Provide legal services for the company's business on a broad array of complex issues within the assigned Practice Category or subdivision thereof
- Develop an assigned subject matter expertise regarding specific legal issues or areas within the assigned Practice Category
- Manage and perform projects that involve complex or difficult issues requiring a high degree of original and constructive legal effort and business acumen
- Provides immediate answers on complex issues from accumulated knowledge and experience
- Establish rapport and a positive working relationship with business unit management and personnel at all levels to encourage and continue the proactive use of in-house legal counsel
- Communicate with business colleagues at all levels in the organization regarding significant decisions, legislation and regulatory rulings that may affect the company's business or policy
- Collaborate with colleagues throughout Global Legal, including serving on Virtual Practice Groups as needed
- Identifies training needs within the organization and develops and presents training materials on relevant laws and legal/business issues
- Conduct or manage the conduct of research and the preparation of analyses concerning a broad range of federal and state legislation
- May supervise work of external legal counsel
- May lead other attorneys or paralegals on projects, as assigned by manager
- Perform special assignments or projects, without significant supervision, as assigned by senior attorneys
- Additional duties as assigned
ADDITIONAL ACCOUNTABILITIES SPECIFIC TO THE JOB:
- Provide legal advice to Takeda s U.S. Business Unit relating to business operations.
- Advise the Office of Ethics and Compliance, Marketing, Sales, Contracts & Pricing, Managed Markets, Government Affairs, Research & Development, Takeda Vaccines Business Unit, and other stakeholders regarding the laws and regulations governing the company s interactions with customers, health care providers, clinical research organizations and sites, government pricing methodologies, and state and federal programs (e.g. Medicare, Medicaid, VA).
- Draft U.S. compliance policies and procedures and template compliance language for commercial agreements entered into by Takeda s U.S. companies.
- Assist the Marketing Department to work with co-promote partners to develop product support infrastructure and programs for co-promote arrangements (e.g. three-way product purchase agreements, consulting arrangements, reimbursement support programs, product distribution arrangements) that comply with fraud and abuse laws, antitrust laws, government pricing requirements, etc.
- Review marketing programs, sponsorships, and medical education grants in the U.S.
- Support compliance audits and conduct internal investigations to ensure compliance with the company s Code of Conduct and other policies.
- Monitor developments in federal, state, and municipal laws, regulations and industry guidance related to fraud and abuse, lobbying and campaign contributions, federal acquisition regulations, restrictions on pharmaceutical company interactions with health care providers, marketing reporting laws, sample and disposal laws, and other issues.
- Retain and direct the activities of outside counsel, where appropriate.
GOVERNMENT CONTRACTS & PRICING
- Approve government pricing methodologies (AMP, ASP, BP, Non-FAMP, FCP) and negotiate with the Centers for Medicare & Medicaid Services when repayment or recoupment of rebates is warranted.
- Assist Contracts & Pricing Department to negotiate government procurement contracts (e.g. Federal Supply Schedule Agreement) and other federal and state rebate or discount program agreements (e.g. Tricare Rebate Agreement, SPAP Agreements).
- Assist the Vaccines Business Unit to negotiate federal government contracts and government subcontracts.
- Oversee compliance with government contract provisions, including submission of reports and cost reimbursement audits.
MANAGED MARKETS AND CONTRACTS & PRICING
- Assist in drafting and negotiating rebate and chargeback agreements with PBMs and health plans.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Juris Doctor
- A minimum of 7 years of experience in one of the following: law firm or corporate law department; government agency; contract administration; risk management; other relevant experience
- Pharmaceutical industry experience preferred.
SPECIFIC TO THE JOB:
- Significant law firm or corporate legal department experience advising biopharmaceutical companies on health care compliance law.
- Strong understanding of laws, regulations and industry guidance related to health care compliance and government programs, including the PDMA, anti-kickback statutes, federal acquisition regulations, Medicare, Medicaid, and VA program regulations, CMS regulations regarding government pricing metrics, false claims statutes, the PhRMA Code, OIG guidance and CMS regulations and analogous laws and regulations in foreign jurisdictions.
- Experience leading internal investigations.
- Experience in advising clients regarding government contract strategy and compliance.
- Experience negotiating and drafting commercial rebate agreements, and ability to make quick decisions in the context of fast-paced negotiations.
- Strong background in the operations of U.S. government health care programs.
- Proven ability to quickly understand and assimilate large amounts of detailed information and communicate in a concise manner to senior management.
- Experience leading large work groups/committees.
- Licensed to practice law Illinois license preferable (other states considered). Must receive Limited Admission as House Counsel in Illinois within one year of hire, if not already admitted to practice in Illinois.
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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