Director, Senior Counsel - Regulatory & Compliance

Overview

California, US residents  () .

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. 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.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

The Director, 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 assisting with, and at times managing, 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 a Legal representative on the Company s promotional review committee, including review of promotional and sales training materials

• Provide legal support for the Company’s Patient Relations function, including providing advice related to reimbursement support, patient support programs, therapy access managers, patient navigators, and nurse educators

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

• Serve as a Legal representative on the Company’s medical communications review team, including review of Field Medical materials, medical information letters, health economic related materials, and social media posts

• Assist with reviewing, drafting and/or revising 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

• Provide guidance to the Company’s Compliance Committee, as needed

• 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

• 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…