Executive Director, Lead Franchise Counsel (Sleep/Neuroscience) at JAZZ PHARMACEUTICALS PLC in Philadelphia, PA

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:

The Executive Director, Lead Franchise Counsel (Sleep/Neuroscience) is a senior member of our legal team who is responsible for providing this cross-functional franchise with legal counsel and handling a variety of commercial matters and business transactions. This position will act as lead franchise counsel and lead a legal team in support of all Neurology products and product candidates, and will provide substantive advice to cross-functional departments including the Global Franchise and Molecule Teams, Global Commercial Development and Planning, North America Commercialization Team, Medical Affairs, and Regulatory Affairs. The Lead Franchise Counsel will oversee and provide counsel concerning a broad range of legal issues, including, among other things, application and interpretation of 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, and interactions with patients and healthcare professionals.

Essential Functions

• Provides strategic, operational and tactical legal and business insight on the regulatory approval and commercialization of sleep/neuroscience products including the launch of Jazz product candidates in North America • Provide legal advice and counsel related to the development of regulatory and business strategies related to the development and commercialization of Jazz product candidates and marketed products. Review and advise on strategies, programs, initiatives, contracts, policies and training related to sales, marketing, medical and other non-promotional education and scientific exchange • Review and advise on promotional materials, field training materials, product and disease-related communications and health economics materials; Serve as a subject matter expert in the areas of US healthcare law and all applicable pharmaceutical marketing, anti-kickback, privacy, fraud and abuse, anti-bribery, Sunshine Act and product liability statutes and regulations • Identify training needs within the organization; develop and present training sessions on relevant laws and legal/business issues • Stay abreast of and communicate to the organization all significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law • Closely coordinate risk assessment, investigation, training and update activities with Jazz Compliance personnel.

Required Knowledge, Skills, and Abilities

• Strong interpersonal and oral and written communication skills • Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriate • Solid understanding of business goals and legal and regulatory landscape • High degree of personal, professional and corporate ethics, integrity and responsibility • Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals • Consistently shows initiative, and willing and able to take high levels of responsibility for complex initiatives • Shows flexibility and is open to change in a growing, multi-cultural environment • Team player, able to work well with others and communicate with cross-functional colleagues and senior leadership • Capable of strategic thinking and proposing innovative solutions to compliance-related challenges • Ability to build, manage and/or develop a high-performing team • Comfortable in a results-driven, highly accountable environment where you can make a clear impact; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company’s business and culture • A collaborator who communicates in an open, clear, complete, timely and consistent manner.

Required/Preferred Education and Licenses

• JD degree or equivalent;
• Ten or more years combined experience in-house and/or with a national law firm.
• Strong understanding of and experience with laws and regulations, legal and contractual principles and intellectual property matters applicable to commercial activities of pharmaceutical companies within the United States.
• Demonstrated familiarity with the broader legal issues facing pharmaceutical companies internationally.
• Experience in working with the pharmaceutical or biotech industry is required.
• Excellent communication skills, both oral and written; ability to lead teams; ability to handle heavy workload for multiple clients; team player with strong interpersonal skills.
• Experience leading a team preferred.

Description of Physical Demands

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.