Director, Senior Counsel, Regulatory & Compliance (Remote)

United Therapeutics Director, Senior Counsel, Regulatory & Compliance (Remote)

Location : Juneau, Alaska

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. Our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have successfully gained FDA approval for five medicines, are always conducting new clinical trials, and 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 the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs.

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 provides expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs, and Corporate Compliance.

• Provide guidance related to the Food Drug and Cosmetic Act, 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.
• Review Needs Assessment Forms related to HCP consulting activities.
• Serve as the Legal representative on the Company’s medical communications review.
• Assist with the review, drafting, and / or revising of compliance-related policies and standard operating procedures.
• Assist with privileged compliance audits and investigations.
• Participate in and provide guidance to the Company’s Compliance Committee.
• Assist the Compliance Department with annual Risk Assessment and Mitigation process.
• Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed.
• 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

Preferred Qualifications

The salary for this position ranges from $230,000 to $285,000 per year. This role is eligible for the Company’s short-term and long-term incentive programs.

At United Therapeutics, you’ll learn, grow, contribute, have fun, and be challenged 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, and paid parental leave benefits.

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

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Remote working / work at home options are available for this role.

Salary : $230,000 - $285,000