General Counsel, Therapeutics

The General Counsel Therapeutics supports Regional and Global functions and colleagues by providing proactive legal advice and counsel on issues associated with relevant areas of law, general business and a wide variety of regulatory and other technical matters. Legal support will include the development, manufacturing, promotion, distribution and sale of pharmaceuticals and the compliant promotions of same; counsel on and manage risk related to the Company and the sale of its products; taking an active role in the day-to-day management of the NA Therapeutics Legal function and in corporate governance and mentoring of colleagues; playing a key role in supporting the development, acquisition and divestiture of products and lifecycle management; and providing effective legal support for sales, marketing and manufacturing/supply functions.

This position has one direct report and requires (a) active management and related leadership associated with internal clients vis-à-vis continuous education, risk management and expectation-setting, (b) external counsel vis-à-vis time and work product and (c) external vendors and third parties in the development and negotiation of contracts and provision of services. The General Counsel reports directly to the President of Therapeutics - North America and has a dotted reporting line to the Global General Counsel Therapeutics.

REQUIREMENTS:

Counseling Business

Analyze legal issues relating to a variety of business activities (including external interactions with customers, suppliers, competitors, government agencies as well as internal Company interactions) to effectively guide the business in conducting its operations in a competitive and compliant manner. Analysis and guidance includes creatively developing and recommending effective and efficient solutions to internal business clients.

Pricing and Government Pricing

Counsel Therapeutics and Finance on government price reporting in connection with sale and distribution of products reimbursed by Medicare, Medicaid and State Healthcare Programs. Counsel clients on laws and regulations related to drug pricing and practices in the areas of mandated pricing programs, provider reimbursement support, and patient co-pay programs. Knowledge of contracting with the Veterans Administration, FSS, and DOD.

Promotional Review

Provide FDA regulatory advice to the President and to the Vice President of Marketing and product marketing teams; advise on promotional materials and provide counsel and guidance on regulatory and promotional requirements and risk assessment regarding product claims.

Managed Markets/Neuro

Provide counsel to Therapeutics Managed Markets on contractual arrangements with payers and potential legal issues, including government pricing, anti-kickback, relationships with healthcare providers and FDA regulations; negotiate, draft, and review payer agreements and other discount agreements in consultation with stakeholders including Finance and Compliance.

Medical Affairs

Advise on scientific exchanges, investigator initiated trials, and medical information materials in collaboration with Medical Affairs.

Contract Reviews

Draft, review, and negotiate a wide range of general commercial and general business contracts, including master services agreements and statements of work, and strategic alliance agreements; ensure that contracts are in compliance with legal and regulatory requirements and organization policies; act as contract liaison between the organization and customers/vendors, including participation in contract negotiations; counsel commercial business units on potential legal, regulatory and compliance implications of contracts.

Supervisory Duties

Supervise the activities of the Assistant General and support their professional development; set appropriate priorities and timelines and provide constructive feedback.

IP/Brand Protection

Provide general advice on intellectual property issues, including trademark, copyright and patent issues in consultation with Global Trademark Counsel and Patent Affairs. Support North America Therapeutic brand protection efforts to protect the company’s products and IP, and the commercialization of the company’s products in NA from trademark infringement, counterfeiting and diversion.

Other duties as assigned

Data privacy officer

REQUIREMENTS:

Graduation from an American Bar Association approved law school; licensed to practice law in any State in good standing; excellent academic credentials.

Minimum 12 - 15 years overall relevant legal experience in law firm and corporate legal department settings; at least 7 of those years must be in the legal department of a pharmaceutical a company with reimbursed products.

Prior experience with corporate governance, intellectual property and business development formalities.

Pharmaceutical product promotional/marketing experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

Ability to think creatively in a heavily regulated environment and handle multiple complex matters.

Ability to think creatively in a heavily regulated environment and handle multiple complex matters.

Excellent working knowledge of the reimbursed drug space and the applicable laws and regulations governing drug and device promotion.

Demonstrated ability to identify and analyze complex issues in order to devise solutions and successful strategies.

Demonstrated ability to work effectively with and lead Legal Department staff.

Ability to interface and work effectively with Global/International colleagues in Legal and other functions.

Advanced working experience in the Managed Markets and strategic pricing spaces on contractual arrangements with payers and other third parties and other potential legal issues, including government pricing, anti-kickback statutes, relationships with healthcare providers and FDA regulations. Part B “buy and bill” experience preferred.

Highest ethical standards and respect of confidentiality for company matters.

Excellent analytical, oral and written communication skills.

Excellent interpersonal skills with ability to work cooperatively in an organization and with management.

Qualifications

Education

Required

Bachelors or better in Law.

Experience

Required

12 years: Minimum 12 - 15 years overall relevant legal experience in law firm and corporate legal department settings.