Legal Counsel, North American Brand Attorney

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

The Legal Counsel, North American Brand Attorney will provide actionable and patient-centered legal advice in North America to allow Ultragenyx to appropriately meet brand objectives, with a focus on FDA labeling and promotional matters, healthcare fraud and abuse, pricing, antitrust, privacy, and product liability issues. This individual will have responsibility for managing legal risk associated with commercial products and late-stage clinical programs across disease areas and modalities, with exciting opportunities to support gene therapy, biologics, and ASO launches in the coming years.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Serve as legal advisor and core brand attorney to commercial, medical, and development teams for late-stage and marketed products. Key clients include sales and marketing, market access, pricing and distribution functions, patient services, medical affairs, HEOR, clinical trial recruitment functions, and molecular diagnostic programs.
• Lead and manage the overall legal risk assessments to ensure appropriate and comprehensive understanding of potential enterprise risk, escalation, and resolution. Key legal risk areas include Anti-Kickback Statute, FDA promotional regulations, product liability, antitrust, privacy, and pricing regulations.
• Advise on business strategies, tactical plan development, and implementation (e.g., brand plans, promotional materials, training documents, corporate communications), including by serving as lead attorney on cross-functional teams for launches and commercial products, such as label review committees, launch standing teams, North America franchise teams, and promotional and other material review committees.
• Counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, patient organizations, academic institutions, and payors.
• Collaborate with legal colleagues and cross-functionally to ensure robust, integrated and complete client counseling.
• Work collaboratively with compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends.
• Lead educational sessions for legal group and company.
• Manage external counsel and associated spend.

Requirements:

• 5+ years in legal counselling role in the pharmaceutical industry, with substantial experience advising on commercialized product strategies and reviewing promotional materials.
• 9+ years of legal experience.
• J.D. with active membership and good standing with U.S. state bar.
• Experience with Anti-Kickback Statute and FDA promotional regulations required; product launch experience and technical knowledge and/or business acumen preferred.
• Sound judgment; excellent written and oral communication skills; strong analytical and problem-solving skills; a high level of intellectual, professional, and interpersonal agility and flexibility; efficient an effective decision making; proven ability to assess and calibrate and effectively communicate about legal risks.
• Self-motivated, work well independently on projects, meet aggressive deadlines, handle multiple projects, willingness to take initiative.
• Team oriented with ability to work in a collaborative, global environment; excellent interpersonal and conflict resolution skills; ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations.
• High level of business ethics.
• Occasional travel required. #LI-CK1 #LI-Hybrid