Senior Counsel, US Commercial

Position SummaryIndivior is looking for an experienced, talented, agile attorney to join its solution-oriented legal team in our Richmond, VA offices. The qualified candidate will work closely and cross-functionally with a broad spectrum of internal business and legal teams to support a values-driven specialty pharmaceutical company. This role reports to the Associate General Counsel who serves as the lead commercial attorney supporting Indivior’s U.S. business. In this multi-faceted role, the Senior Counsel will be focused on providing advice and counsel on the legal risks and requirements associated with branded prescription pharmaceutical products including the Anti-Kickback Statute, the False Claims Act, the Food, Drug and Cosmetic Act, FDA advertising & promotional regulations, OIG Guidance, the PhRMA Code and the Sunshine Act.Essential FunctionsProviding regulatory and strategic guidance to internal business teams on compliance with Federal and State healthcare fraud and abuse laws and regulations applicable to pharmaceutical manufacturers;Reviewing promotional materials and other internal and external communications for compliance with applicable laws, regulations, and policies;Developing, revising, maintaining, and operationalizing policies, procedures, and related trainings to ensure compliance with regulatory and industry laws, rules, and regulations;Collaborating with business functions and legal team members to create, streamline and improve internal processes and best practices to support business needs, generate efficiencies and incorporate compliance by design;Identifying areas of company risk, developing proposals to mitigate risks, and leading implementation of mitigation strategies;Supervising outside counsel, other vendors and related budgets;Performing special assignments and projects as needed.Minimum QualificationsJ.D. from an accredited law school.Admission and membership in good standing to the bar of at least one State or Washington, D.C.At least 5 years of relevant legal experience, including at least two years of in-house at a pharmaceutical or biotechnology company or at a law firm representing pharmaceutical or biotechnology companies handling regulatory and commercial matters.Preferred QualificationsAt least 2-5 years of law firm experience primarily focused on handling regulatory and commercial matters for pharmaceutical and biotechnology companies.At least 4 years of experience providing legal advice and counseling as an in-house attorney with a pharmaceutical or biotech company.Experience identifying various regulatory issues, with a focus on the False Claims Act, healthcare fraud and abuse laws and FCPA / UK Bribery Act as it relates to pharmaceutical companies.#J-18808-Ljbffr