Overview
This role supports the commercial organization by providing practical, timely, strategic, and high-quality legal advice across a range of complex US and global matters. Focus areas include counseling on risk related to Federal Trade Commission (FTC) guidance, fraud and abuse, anti-kickback, US Food and Drug Administration (FDA) and Office of Inspector General (OIG) guidance, product liability issues, privacy, reputational risk, and various state and federal laws (including the False Claims Act, Sunshine Act, CAN-SPM, TCPA, and related requirements).
Responsibilities
- Provide solutions-oriented legal advice in the promotional review of marketing, sales, medical, and training assets in conjunction with regulatory and medical partners.
- Provide strategic legal advice and proactive solutions to commercial business teams.
- Advise internal stakeholders on compliance with applicable federal and state healthcare laws, regulations, and industry standards (including FDCA, AKS, and PhRMA Code).
- Provide advice on internal and external communications by non-marketing and sales functions.
- Provide practical and timely legal guidance on sales and marketing, market access, patient advocacy and patient services, medical information, fee-for-service arrangements, drug pricing, data privacy initiatives, social media, use of endorsers and/or celebrities, drug labeling, strategic plans and tactics, competitive issues, and interactions with nonprofits.
- Support Government Affairs and coordinate with external counsel on GA matters when needed.
- Represent Legal on various cross-functional committees and teams.
- Collaborate with legal, regulatory, and compliance colleagues on guidance and input for complex agreements.
- Support regulatory, medical affairs, and product development teams, including legal interpretation of laws, regulations, and guidance documents related to development and commercialization of pharmaceutical and biopharmaceutical products.
- Provide education and training of business and cross-functional stakeholders on commercial best practices and policies.
- Identify opportunities to enhance the effectiveness of Legal department operations and actively participate in department initiatives.
- Assist with internal policies, training, and corporate governance initiatives.
- Participate in business development activities (including merger and acquisitions, licensing, and other partnering opportunities), covering deal and risk assessment and due diligence.
- Perform other duties as assigned.
Requirements
- Juris Doctor (JD) from an ABA accredited school.
- Licensed and in good standing in at least one U.S. State.
- Licensed to practice law in at least one state and in good standing.
- Minimum 5–7 years of experience working in a law firm and/or pharmaceutical or biotechnology legal department, with at least 2+ years’ in-house experience in the biotech and/or pharmaceutical industry.
- Understanding of legal issues affecting the pharmaceutical industry, including regulatory processes and guidance for prescription and OTC drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption, and antitrust laws.
- Working knowledge of the global regulatory environment.
- In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory, and commercial elements.
- Strong analytical problem-solving and decision-making skills, sound judgment, and the ability to provide practical, constructive legal advice in a time-sensitive, dynamic environment.
- Strong negotiation and communication skills (oral and written), including the ability to explain legal issues clearly and build trust across functions and sites.
- Ability to work independently and take initiative to drive priorities, complete tasks, and appropriately manage risks.
- Strong work ethic and ability to manage a large workload while meeting client needs directly and with Legal, Regulatory, and Compliance teams.
- Strong oral, written, and presentation skills; ability to clearly articulate complex information.
- Strong analytical and problem-solving skills with attention to detail.
- Ability to establish and maintain effective working relationships throughout the organization.
- Experience supporting products ex-US is highly desirable.
Preferred Qualifications
- Experience supporting products ex-US.
- Experience working in a matrix environment.
Compensation & Benefits
- Estimated annual base salary range for new hires: $206,500 to $250,000.
- Individual base pay depends on factors including education, experience, skills, abilities, internal equity, and alignment with market data.
- Salary may be adjusted based on geographic location.
- Certain roles may be eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
- Comprehensive benefits package (eligibility governed by applicable plan documents and policies).
Location
- United States (U.S. base pay ranges and benefits information provided).