Product Counsel

Overview

The Product Counsel, North America will be responsible for reviewing promotional, nonpromotional, payer, and scientific materials, evaluating strategic and tactical commercial/brand, market access, patient support and medical affairs plans, supporting commercial and non-commercial clinical and medical education initiatives, and advising clients on a broad array of advertising, marketing, promotional review, healthcare professional (HCP) and patient engagement, payer communication, and other business activities. This role will also advise on patient and data privacy requirements related to the management and storage of patient information; draft and negotiate commercial and research agreements; and oversee contract execution and lifecycle management.

Essential Duties and Responsibilities

• Work on cross-functional business teams and proactively develop robust partnerships with commercial and non-commercial stakeholders.
• Provide timely legal and regulatory advice to business partners regarding the marketing of pharmaceutical drugs, scientific exchange, and brand lifecycle management.
• Review promotional materials and tactics including HCP and consumer-directed advertising as well as nonpromotional disease education and scientific materials in accordance with current FDA and FTC regulations, guidance, and enforcement activity, and counsel on risk mitigation strategies as needed.
• Advise on health economics and outcomes research (HEOR) and payer communications in accordance with applicable FDA guidance.
• Draft, review, negotiate, and advise on a broad range of commercial agreements, including vendor, services, consulting, licensing, technology, and confidentiality/non-disclosure.
• Support the legal needs of clinical development and research activities, including clinical trial agreements (CTAs), investigator-sponsored research (ISR/ISS) agreements, collaborative research agreements, informed consent considerations, and related data use arrangements.
• Support business initiatives involving the collection, use, disclosure, and transfer of personal, patient, healthcare professional, clinical research, and other sensitive data.
• Advise on third-party risk management, data processing arrangements, cybersecurity incidents, and contractual privacy and security obligations.
• Track and advise senior leadership on current federal and state legal and regulatory risks and enforcement trends relevant to the life sciences industry.
• Monitor commercial and medical field interactions as needed.
• Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion.
• Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
• Perform additional duties as may be assigned.

Education and Experience

• Juris Doctorate (J.D.) or LLM degree from an accredited law school.
• Admitted to the Bar of at least one state and eligible for admission to the New Jersey Bar as in-house counsel.
• A minimum of 5 years of relevant experience. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company strongly preferred.
• Experience with federal and state regulations governing the life sciences industry.
• Experience as Legal reviewer on promotional and non-promotional review committees (MLR, PRC, MRC, etc.)
• IAPP CIPP certification preferred.
• Healthcare Compliance certification preferred.
• Excellent critical thinking skills; ability to work through complex issues.
• Strategic, analytical thinker and creative

Knowledge and Skills

• Ability to be proactive, exercise judgment and manage multiple responsibilities simultaneously.
• Strong organizational skills with the ability to handle and prioritize a high volume of work.
• Proficiency in Microsoft Office and the appropriate use of authorized AI tools.
• Strong written and verbal communication skills.