Associate Director US Legal Affairs and Corporate Counsel

Lundbeck•Boston, MA

About The Position

The Associate Director, Legal Affairs serves as a strategic, solution-oriented business partner to assigned leaders across the organization. The role builds strong stakeholder relationships and enables business objectives through practical legal guidance and sound risk management. It advises on complex legal, regulatory, and operational issues across commercial, technology, and healthcare matters, helping shape strategies that support business objectives, innovation, emerging technologies, commercial initiatives, patient-focused programs, and strategic collaborations while protecting the company’s interests and ensuring compliance with applicable laws and regulations. The position provides strategic legal counsel to U.S. business functions, including Marketing, Medical Affairs, and Regulatory Affairs, on marketed pharmaceutical products, pipeline assets, and commercialization activities. It supports clinical development, pre-launch activities, launch planning, compliant launch execution, scientific exchange, stakeholder engagement, advertising and promotional review, external communications, and related regulatory and legal matters. The role also advises on patient and caregiver engagement and other healthcare initiatives, supports compliance frameworks, policies, and training, and collaborates broadly with internal teams and outside counsel. It may provide support to the General Counsel on strategic initiatives, complex matters, and investigations as assigned. The role requires a Juris Doctor from an ABA-accredited law school and admission to the Massachusetts Bar, or eligibility and willingness to obtain admission. Candidates must have at least seven years as an attorney or counsel, including at least two years with a law firm, and relevant legal counseling experience in a regulated industry. Travel up to 10% domestically is expected; international travel may also be required.

Requirements

Juris Doctor (JD) degree from an ABA-accredited law school.
Admission to the Massachusetts Bar, or eligibility and willingness to obtain admission.
Seven or more years as an attorney or counsel, including at least two years with a law firm.
Experience providing general corporate and/or commercial legal counsel, in-house or in private practice, within the pharmaceutical, biotechnology, medical device, or another highly regulated industry.
Knowledge of FDA drug and biologic law, the False Claims Act, the Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, the Foreign Corrupt Practices Act, competition law, and U.S. pharmaceutical regulations.
Excellent oral, written, and interpersonal communication skills, including the ability to present legal guidance to all levels of the company, from operational management to C-suite executives.
Ability to manage multiple projects, meet deadlines, and communicate effectively with colleagues and employees at all levels.
High degree of personal, professional, and corporate ethics, integrity, and responsibility.
Willingness and ability to travel up to 10% domestically; international travel may also be required.

Nice To Haves

Litigation experience.
Knowledge of international law relevant to the industry.
Experience supporting commercial functions in the pharmaceutical, biotechnology, or medical device industry.
Experience supporting advertising and promotional review.
Knowledge of or experience in rare disease.

Responsibilities

Serve as a trusted legal advisor and strategic business partner to assigned leaders, helping shape business decisions through practical, solution-oriented counsel.
Partner with cross-functional stakeholders to address complex legal and regulatory issues while enabling business objectives.
Identify legal risks, evaluate alternatives, and develop balanced, business-focused solutions.
Integrate legal considerations into business planning, operational execution, enterprise initiatives, and innovation efforts.
Advise U.S. business functions, including Marketing, Medical Affairs, and Regulatory Affairs, on marketed products, pipeline assets, and commercialization activities.
Provide counsel on relevant healthcare laws, regulations, and industry standards in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales activities and compensation, pharmacovigilance, medical information, scientific exchange, and interactions with healthcare professionals.
Advise on clinical development, pre-launch activities, and launch planning, and partner with Medical Affairs, Commercial, Market Access, and Regulatory teams on compliant launch execution and stakeholder engagement.
Guide advertising, promotional, marketing, educational, and other external communications, including communicating the implications of significant legal and regulatory developments.
Maintain awareness of intellectual property status for strategic brands and liaise with the Intellectual Property team.
Counsel stakeholders on legal issues involving patient and caregiver engagement, commercial activities, and other healthcare-related initiatives.
Guide the development of compliant, patient-centered solutions and support compliance frameworks, policies, and training tailored to rare disease commercialization and patient and caregiver engagement.
Cultivate relationships across Legal, Compliance, Commercial, Medical Affairs, Regulatory Affairs, Market Access, Research & Development, Information Technology, Finance, and other functions.
Translate complex legal concepts into practical guidance and communicate legal issues and risks to internal and external stakeholders, including operational management and C-suite executives.
Collaborate with Global Legal, Regulatory, and Compliance teams to align U.S. strategies with enterprise goals and support compliance for global activities involving U.S. stakeholders or events.
Serve as legal representative on business and operational committees and as a subject-matter resource to colleagues.
Improve legal processes, contract templates, governance frameworks, and best practices.
Partner with and direct outside legal counsel, as appropriate, on complex legal matters, regulatory developments, commercial activities, and other business priorities.
Provide legal counsel and support to the General Counsel on strategic initiatives, complex legal matters, and internal or external investigations, as assigned.