Legal Counsel, North American Brand Attorney at Ultragenyx in Somerville, MA

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

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

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$247,200—$305,300 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.