Counsel - Regulatory and Compliance (Brand Attorney)

The job details are as follows:

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

Corporate counsel 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 Pharmaceutical Compliance Guidance, the PhRMA Code, the Sunshine Act, and related state regulations. Primarily responsible for providing expert legal support to Sales, Marketing, Medical Affairs, Regulatory and Corporate Compliance, and other corporate departments to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products.

• Serve as Legal representative on promotional review committee and medical communications review, including review of promotional materials, sales training, field medical materials, and medical information letters
• Provide guidance to Sales, Marketing, Medical Affairs and Corporate Compliance departments related to the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
• Assist with the review, drafting and/or revising of Company compliance related policies and standard operating procedures
• Assist with privileged compliance audits and investigations
• 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
• 8+ years of experience in healthcare and FDA law
• 6+ years of experience with a pharmaceutical or biotechnology company
• Must possess both a solid command of relevant legal subject matter and 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

Preferred Qualifications

• Strong written communication and drafting skills
• Mac/PC and MS Office proficient
• 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.

#LI-Remote

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