:Associate Legal Counsel :Kyowa Kirin : https://www.kyowakirin.com/ :Degree Of Law : 3
As a supporting member of the North American Legal Department, the Associate Counsel will provide legal counsel to Kyowa Kirin Inc’s U.S. business (Company or Organization”) , with a focus on contracting and advising on operational matters related to the commercialization of marketed products supporting marketing, sales, medical affairs, managed markets, commercial operations, public affairs, HR and other business groups. The successful candidate will need to be able to collaborate with many departments across the business and have experience drafting, negotiating and managing a high volume of contracts while providing practical, solution oriented legal advice in an understandable manner to accomplish business objectives. The ability to identify business and legal issues as well as distinguish between real and theoretical risk when evaluating matters and communicating with business clients is essential. While this position is primarily focused on contracts, the candidate will also assist as directed on other matters supporting the US business as deemed appropriate and dictated by business needs.
The ideal candidate will have some experience working in or with clients in the pharmaceutical industry and a strong competency on advising on pharmaceutical business issues, and healthcare compliance laws. The successful candidate will be knowledgeable of U.S. pharmaceutical laws, regulations, and industry standards (the Anti-Kickback Statute, Food and Drug Administration laws and regulations regarding the promotion of pharmaceuticals (including the Prescription Drug Marketing Act), the False Claims Act, OIG Guidance, the PhRMA Code and federal and state transparency reporting requirements (Sunshine Act), and should be able to apply such laws, regulations and standards to inform business activities. The candidate will have strong legal research and analytical skills and contract drafting skills.
Draft, review and negotiate contracts with healthcare professionals and organizations including consulting, advisory boards and speaker program agreements
Support multiple business units and corporate functions by drafting, reviewing and negotiating a variety of contracts, including vendor agreements (master service agreements and related scopes of work), marketing service, advertising, public relations and agency agreements, grants and sponsorship agreements, publications agreements, market research agreements, software license and technology agreements, confidentiality agreements, hotel/event agreements and other corporate agreements.
Review proposed contractual arrangements from a compliance perspective and establish guardrails consistent with company compliance policies and procedures
Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align with and achieve business strategic goals.
Work closely with the paralegal to ensure all necessary templates are drafted, current and communicated to stakeholders.
Assist the paralegal in developing policies and procedures and related training for efficient contract review and approval in the contract management system.
Willingness to learn new areas, including reviewing advertising and promotional marketing materials as a member of the promotional review committee to help ensure compliance with applicable laws and regulations.
Agility and willingness to learn about various subject matters (both from a legal and business perspective,) are highly valued.
Working closely with other members of the legal department and compliance group raise awareness, while fostering accountability of ethics and compliance programs throughout the Company.
Prepare and present legal/compliance training to the commercial and medical home office and field teams including new employees as well as external service providers as needed.
Act as a business partner while providing solutions-oriented legal advice.
Proactively communicate and manage expectations with multiple constituencies.
Set a tone of the highest legal and ethical standards of conduct, and possess the poise to achieve highly effective working relationships throughout the Company and externally.
Minimum of 3 years pharmaceutical commercial or compliance experience in a law firm or in-house (preferred)
Experience with cross-functional teams and demonstrated ability to partner effectively with others to address complex compliance and operational issues
Must have a good understanding of the pharmaceutical industry and related regulatory environment
Knowledge of U.S. pharmaceutical laws, regulations, and industry standards the Anti-Kickback Statute, Food and Drug Administration laws and regulations regarding the promotion of pharmaceuticals the False Claims Act, OIG Guidance, and the PhRMA Code.
Ability to multi-task, prioritize and handle multiple contracts at the same time.
Requires a high level of balanced judgment and an ability to independently discern and establish priorities.
Positive outlook/attitude team player looking to join a dynamic and growing organization/legal group.
Strong project management skills.
Excellent organizational skills and responsive with demonstrated attention to detail and accuracy.
Strong proficiency in Microsoft Word, and PowerPoint.
Excellent oral and written communication skills.
Possible travel requirements of <10% of the roles time.
Undergraduate degree from a college or university of recognized standing.
Law degree with strong academic credentials. Licensed in good standing to practice law in at least one state within the United States, preferably New Jersey.
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