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.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
- Provide legal support to business clients in connection with clinical (not commercial) contracting activities.
- Draft, review and negotiate a wide variety of clinical contracts including confidentiality agreements, consulting agreements, services agreements, Clinical Trial agreements, in support of all clinical functions of Takeda Global Research & Development, Inc. and certain of its international affiliates, primarily in the Americas.
- Implement and oversee processes, systems and workflow relating to clinical contracts, including oversight of activities delegated to CROs or other outside vendors.
- Create and maintain appropriate template contracts for use by R&D Law.
- Identify and assess the corporate impact of relevant legal trends, laws and regulations within R&D
- Identify legal and Takeda policy issues and work with Legal Department colleagues, the Office of Ethics and Compliance, business clients and others to address such issues.
- Research legal issues that may arise related to the company’s clinical business and contracts.
- Assist business clients with contract and other clinical disputes that may arise, working with appropriate Legal Department colleagues and outside counsel as needed.
- Provide oversight and direction to R&D Law paralegals with contract drafting and negotiation.
- Juris Doctorate is required.
A minimum of 7 years of experience strongly preferred in one of the following: law firm or corporate law department; government agency; contract administration; risk management; other relevant experienceLaw firm or corporate in-house legal department experience in drafting and negotiating clinical contracts and advising on clinical contracting matters is required.
- Experience with laws, regulations and industry guidance related to health care compliance preferred (e.g., PDMA, anti-kickback statutes, false-claims statutes, the PhRMA Code, OIG guidance) is preferred
- Pharmacy industry experience preferred.
Licensed to practice law - Illinois license preferable (other states considered)
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 18 months ago