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
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.
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
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.
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.
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.
Advise on scientific exchanges, investigator initiated trials,
and medical information materials in collaboration with Medical
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
Supervise the activities of the Assistant General and support
their professional development; set appropriate priorities and
timelines and provide constructive feedback.
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
Graduation from an American Bar Association approved law school;
licensed to practice law in any State in good standing; excellent
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.
Excellent working knowledge of the reimbursed drug space and the
applicable laws and regulations governing drug and device
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
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”
Highest ethical standards and respect of confidentiality for
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.
12 years: Minimum 12 - 15 years overall relevant legal
experience in law firm and corporate legal department settings.
Equal Opportunity Employer/Protected Veterans/Individuals with
The contractor will not discharge or in any other manner
discriminate against employees or applicants because they have
inquired about, discussed, or disclosed their own pay or the pay of
another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as
a part of their essential job functions cannot disclose the pay of
other employees or applicants to individuals who do not otherwise
have access to compensation information, unless the disclosure is
(a) in response to a formal complaint or charge, (b) in furtherance
of an investigation, proceeding, hearing, or action, including an
investigation conducted by the employer, or (c) consistent with the
contractor’s legal duty to furnish information. 41 CFR