Associate Director, Corporate Counsel, Commercialization and Market Access (Remote)

Role Summary

The Associate Director, Corporate Counsel, Commercialization and Market Access is an integral member of the legal team responsible for providing legal support for one or more brands and related business functions. The role provides counsel on a broad range of legal issues, including FDA regulations, the False Claims Act, Anti-Kickback Statute, and competition law in connection with regulatory strategy, product labeling, promotional and non-promotional activities, medical and marketing strategies, sales compensation, interactions with patients and healthcare professionals, patient assistance programs, and other areas.

Responsibilities

• Provide legal support for one or more brands and/or franchises and related business functions. This includes serving as the primary legal representative on promotional materials review committee medical materials review committee, providing solutions-oriented legal advice and counsel on marketing and medical affairs strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, FDA labeling, healthcare fraud and abuse laws, anti-kickback statute and other laws impacting the commercialization of pharmaceutical products in the U.S.
• Working closely with colleagues in the CLO Organization, provides legal support related to the development of regulatory, commercialization, and business strategies for Jazz product candidates and marketed products.
• Proactively identify potential legal risks; formulate and communicate compliant and practical solutions that meet the company’s strategic objectives and priorities.
• Partner with the business to identify creative strategies to keep within budget goals and expectations.
• Conduct thorough and reasoned analysis of increasingly complex legal issues and develop creative and effective solutions using in-depth knowledge of the company, relevant laws and regulations, the external environment, and industry best practices.
• Guide colleagues on appropriate relationships with healthcare professionals, patients, managed care entities, healthcare organizations and government officials and entities.
• Apply legal expertise, drafting, and negotiation skills to counsel and support stakeholders to effectively manage risks on contractual matters, including review and negotiation of legal agreements, commercial contracts, vendor agreements, service agreements, and consulting agreements.
• Advise stakeholders on the interpretation of applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization.
• Create and deliver training and other presentations to business partners and other members of team on legal topics and other relevant subjects.
• Drive increased efficiency, coordination, and effectiveness of legal advice, processes and support to meet the needs of the business and other key stakeholders.
• Serve as part of matrixed teams involved in franchise activities and collaborate effectively, find common ground, and build alignment with relevant stakeholders.
• Lead special projects and cross-functional teams that impact the department and business partners.
• Partner with Legal department colleagues in executing and enhancing corporate and department objectives.
• Keep informed of new laws, regulations, and industry trends to identify any potential impacts to the organization.

Qualifications

• Minimum 5 years of combined experience in-house and/or with a law firm. Experience with a biotech or pharmaceutical company preferred.
• Experienced in advising clients on laws and regulations governing the pharmaceutical industry, including but not limited to FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, and product liability laws.
• Must be self-motivated, proactive, strategic, and exhibit excellent judgment.
• Ability to be successful within a fast-paced, evolving environment.
• Possess the ability and willingness to advance new ideas and recognize when decisions may have a broad impact on the global organization.
• Consistently take action and drive issues to closure and hold self and others accountable for achieving results.
• Adept at the ability to develop close, trusting relationships with a diverse set of individuals, characterized by a high-level of collaboration and mutual respect.
• Demonstrates a strong sense of self-awareness and skills to diffuse difficult situations and resolve conflicts.
• Legal analysis and advice are well thought out and accurate, potential legal and compliance issues are consistently identified.
• Ability to create and deliver effective oral presentations, train, and educate stakeholders and members of the department on legal topics and issues.
• Must consistently demonstrate leadership behaviors.

Education

• Juris Doctorate (J.D.) degree; licensed to practice law in the U.S.