The purpose of the Executive Counsel is to deliver legal counsel and services as lead counsel for a business or therapeutic unit(s) (such as the Oncology unit) or shared service/support function (such as Commercial Operations) of the Teva North America Specialty Medicines group under the overall direction of the General Counsel, North America Specialty Medicines. The Executive Counsel is responsible for meeting the legal needs of designated departments and functions, such as sales and marketing teams, managed markets, sales support and other commercial support functions, including agreement negotiation and drafting, labeling and promotional matters and other legal and regulatory issues affecting the sales and promotion of brand drugs, and to ensure that the company is in compliance with applicable laws, rules and regulations (including promotional materials copy review), such as privacy, healthcare fraud and abuse and other laws impacting the business unit or function. The Executive Counsel also serves as a member of the Teva North American legal group.
Delivers timely, competent legal services and counsel in support of various US Specialty Medicines commercial departments or functions.
Represents the company in legal matters related to third parties.
Assists as needed in negotiation of agreements with third parties.
Finalizes agreements with third parties to minimize legal risks and liabilities and to achieve the goals of the department entering into the agreement.
Serves as a member of Promotional and Advertising Review Committees as assigned by the General Counsel.
Ensures that the company is in compliance with all applicable laws, rules and regulations, including serving as a member of a business unit Compliance Committee, CARE Committee for a business unit and/or Grant Review Committee as assigned by General Counsel; monitors compliance and makes recommendations to the General Counsel regarding changes to policies or operations.
Participates in the strategic planning process and in the development of department business plans.
Gives final legal approval for agreements entered into by the company.
Follows Teva Safety, Health, and Environmental policies and procedures.
Other projects and duties as required/assigned.
JD Degree and undergraduate or graduate coursework or degree in science or business.
Minimum of 10 years of practice in a law firm and/or in-house legal department with experience in the branded pharmaceutical, biotechnology or medical device industry.
3+ years in a large law firm plus legal experience in the branded pharmaceutical industry or working on pharmaceutical issues. Experience providing legal counsel and support for marketed oncology products is desired.
Specialized or Technical Knowledge Licenses, Certifications needed:
Must be licensed to practice in PA or KS or eligible for in-house counsel admission
Substantive knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including without limitation, the False Claims Act, the Food, Drug and Cosmetic Act, the Anti-Kickback Statue and safe harbors, the Foreign Corrupt Practices Act, the FTC Act and antitrust laws.
Company/Industry Related Knowledge:
Experience in providing legal review of promotional materials in the context of a Medical/Regulatory/Legal review committee and providing legal counsel on contracting for services from healthcare professionals, including review of grant proposals.
Demonstrated understanding of US FDA laws and regulations governing promotion of pharmaceutical products.
Ability to review promotional materials and provide legal counsel as a member of the promotional review committee for assigned products.
Demonstrated excellence in (i) understanding complex scenarios in order to identify and evaluate for FCPA, fraud and abuse, privacy, FTC, FDA and other types of legal and regulatory compliance related issues and risks, (ii) propose solutions that take into consideration the relevant business objectives, and (iii) communicate those issues, risks and solutions clearly and concisely to lawyers and non-lawyers alike.
Experience in all aspects of drafting standard and non-standard contracts customary to the pharmaceutical industry.
Proven ability/interest in working across a broad range of subject matter areas.
Ability to work collaboratively, with a solution-oriented approach, in teams within legal, business and functional areas.
Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
Ability to lead, motivate and manage others.
Sound judgment, commitment to ethical conduct and high level of professionalism.
Team player with a commitment to developing strong collaborative relationships with clients and cross-functional teams.