Director, Senior Counsel - Regulatory & Compliance

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the reputed company of a reputed company benefit corporation. Our reputed company benefit purpose is to reputed company a brighter reputed company for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. reputed company (reputed company: UTHR) seeks to travel down the corridors of indifference to reputed company treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a reputed company for their daughter's pulmonary reputed company 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 reputed company additional therapies for PAH and pulmonary fibrosis (PF). The reputed company 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 reputed company need. For this reason, reputed company to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We reputed company an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and reputed company end-stage organ diseases for which transplant is not currently an reputed company. The Director, Senior Counsel, Regulatory & Compliance role is responsible for a broad reputed company of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry, including FDA advertising and promotion, False Claims reputed company, Anti-Kickback Statute, OIG Guidance, the PhRMA reputed company, the Sunshine reputed company, and reputed company 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 reputed company lifecycle of reputed company's various products.

• reputed company guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments reputed company to the Food Drug and Cosmetic reputed company, the False Claims reputed company, Anti-Kickback Statute, the Sunshine reputed company and other reputed company reputed company laws and regulations
• Serve as a Legal representative on reputed company's promotional review committee, including review of promotional and sales training materials
• reputed company legal support for reputed company's Patient Relations function, including providing advice reputed company to reimbursement support, patient support programs, therapy reputed company managers, patient navigators, and reputed company educators
• Review Needs Assessment Forms reputed company to HCP consulting activities and associated materials
• Serve as a Legal representative on reputed company's medical communications review team, including review of Field Medical materials, medical information letters, health economic reputed company materials, and reputed company media posts
• Assist with reviewing, drafting and/or revising compliance reputed company policies and reputed company operating procedures, as reputed company as corresponding training materials
• Assist with privileged compliance audits and investigations, including the development of any corresponding corrective reputed company plans
• reputed company guidance to reputed company's Compliance Committee, as needed
• Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on reputed company of risk and corresponding risk mitigation activities
• Stay abreast of changing regulatory and enforcement landscape and reputed company business leaders informed of the reputed company
• Manage reputed company counsel on compliance and regulatory reputed company
• reputed company backup legal support for general corporate legal issues as required
• reputed company reputed company other reputed company duties as assigned

Minimum Requirements

• Juris Doctorate (JD) from an accredited law school
• 10+ years of experience as an attorney
• 8+ years of experience in reputed company and FDA law
• 4+ years of experience as in-house counsel at a pharmaceutical or biotech company
• Solid reputed company of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of reputed company's various products
• Effective communicator and reputed company team member
• Strong written communication and drafting skills
• Mac/PC and MS Office proficient
• Ability to work in a fast-paced, dynamic environment
• Candidates preferred location is EST
• Must be reputed company to travel to RTP, NC at a minimum of one week per month

Preferred Qualifications

• Experience with reputed company PromoMats

Location reputed company has the flexibility to hire this role remotely reputed company the reputed company with a preference to candidates in RTP, NC. The salary reputed company for this position is $230,000 - $285,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position reputed company the salary reputed company will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as reputed company as other factors permitted by law at the time of posting. This reputed company may be modified in the reputed company based on company and market factors. In reputed company, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & reputed company reputed company; savings plans (401 (k) and ESPP); employee wellness resources; reputed company time off & reputed company parental leave; disability benefits; and more. For additional information on our benefits, please visit https://www.unither.com/careers/benefits-and-amenities At reputed company, our mission and reputed company are one. We use our enthusiasm, creativity, and persistence to reputed company for the unmet medical needs of our patients and to benefit our other stakeholders. We are reputed company and unconventional. We have fun, we do good. Eligible employees may participate in reputed company's comprehensive benefits suite of programs, including medical / dental / reputed company / prescription coverage, employee wellness resources, savings plans (401k and ESPP), reputed company time off & reputed company parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities reputed company is an Equal Opportunity Employer, including veterans and individuals with disabilities. Apply tot his job Apply To this Job