What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute

The Senior Counsel, Regulatory & Compliance role is responsible for a broad range of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry, including FDA advertising and promotion, False Claims Act, Anti-Kickback Statute, OIG Guidance, the PhRMA Code, the Sunshine Act, and related state regulations. This role is primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs and Corporate Compliance, and for managing the areas of legal responsibility that become relevant through the commercial lifecycle of the Company's various products.

Provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations

Serve as Legal representative on the Company's promotional review committee, including review of promotional and sales training materials

Support the build out of the Company’s Patient Relations function, including providing advice related to reimbursement support, patient support programs, field reimbursement managers, patient navigators and nurse educators

Review Needs Assessment Forms related to HCP consulting activities and associated materials

Serve as the Legal representative on the Company’s medical communications review, including review of MSL materials, medical information letters, health economic related materials, social media posts

Assist with the review, drafting and/or revising of compliance related policies and standard operating procedures, as well as corresponding training materials

Assist with privileged compliance audits and investigations, including the development of any corresponding corrective action plans

Participate in and provide guidance to the Company’s Compliance Committee

Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on levels of risk and corresponding risk mitigation activities

Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed of the same

Manage outside counsel on compliance and regulatory matters

Provide backup legal support for general corporate legal issues as required

Perform all other related duties as assigned

For this role you will need

Minimum Requirements

Juris Doctorate (JD) from an accredited law school

10+ years of experience as an attorney

8+ years of experience in healthcare and FDA law

4+ years of experience as in-house counsel at a pharmaceutical or biotech company

Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products

Effective communicator and collaborative team member

Strong written communication and drafting skills

Mac/PC and MS Office proficient

Ability to work in a fast-paced, dynamic environment

Position located in RTP, NC

Ability to travel up to 10%

Preferred Qualifications

Experience with Veeva PromoMats

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities