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Senior Corporate Counsel, Health Care

Company: Urovant Sciences, Inc.
Location: Irvine
Posted on: May 3, 2021

Job Description:

Urovant Sciences, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and improving the way providers and their patients confront urologic diseases that are difficult to treat.

 

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

 

Urovant’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.  GEMTESA® is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH).

 

Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.


This position will support the commercial, medical affairs, compliance, and managed markets functions.  This individual will serve as one of the lead attorneys and internal client contact for providing strategic advice on commercial, regulatory, and healthcare compliance issues affecting the marketing and sale of the company’s lead product candidate, vibegron.  The position is based at Urovant’s headquarters in Irvine, CA and reports to the General Counsel.


  • Support global product development and commercial operations. Responsibilities include counseling on laws applicable to pharmaceutical promotion and sales, industry codes and promotional practices, risk management, and mitigation related to commercial and clinical matters.
  • Serve as lead counsel of branded product, including participation in cross-functional committees charged with setting/implementing commercial and medical strategies as well as reviewing advertising, scientific, and other materials (e.g. promotional review committee, medical review committee, etc.).
  • Work directly with the market access team by providing critical legal advice and guidance related to drug pricing, access, and reimbursement issues.
  • Understand the strategic and tactical objectives of the business and develop creative and thoughtful solutions considering the current legal and regulatory landscape, Urovant’s policies and procedures, and the current and future needs of the organization.
  • Exhibit superior legal skills together with a proficiency for critical thinking and problem solving in a multi-functional environment.
  • Be an informed and accessible resource regarding new laws, regulations, and industry trends affecting the company and the biopharmaceutical sector.
  • Liaise with and support Urovant’s compliance function to ensure risk-based advice is consistent with company policies and training messages that can be implemented in accordance with company procedures.

  • Juris Doctor from an accredited U.S. law school; admitted to practice in California.
  • 5 plus years of experience in a healthcare law role in the life sciences industry is preferred.
  • Prior in-house experience as a member of a legal department in a biotechnology or pharmaceutical company is preferred.
  • Experience with new product launches is preferred.
  • Experience at a nationally recognized law firm in an applicable practice area is strongly preferred.
  • Command of relevant laws, regulations, guidance, and industry codes including the federal Food Drug and Cosmetic Act (FDCA) and related FDA Guidance documents, the federal Anti-Kickback Statute, the federal False Claims Act, and the PhRMA Code is required.  Working knowledge of the Health Information Portability and Accountability Act (HIPAA) and applicable privacy laws is preferred.

  • Ability to work in a team environment.
  • Works with integrity and ethically in accordance with Urovant’s Code of Business Conduct and related policies and procedures.
  • Exhibits honesty, integrity, and trust-building behaviors in all dealings.
  • Attention to detail is critical.
  • Self-directed with capacity to collaborate with a team in order to ensure that project milestones are successfully completed.
  • Strong written and oral communication skills, including ability to articulate and communicate with executive leadership.
  • Exercises discretion and good judgment while handling confidential and sensitive information.

Keywords: Urovant Sciences, Inc., Irvine , Senior Corporate Counsel, Health Care, Other , Irvine, California

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