Description:
Position Summary:Indivior 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. In this multi-faceted role, the Corporate 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 Functions:
The responsibilities of this role include, but are not limited to, the following:
- Providing 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; Demonstrating strategic value and competence in applying legal skills to daily in-house corporate, business, and other matters;
- Identifying areas of company risk, developing proposals to mitigate risks, and leading implementation of mitigation strategies;
- Supervising outside counsel, other vendors and related budgets; and
- Performing special assignments and projects as needed
Minimum Qualifications:
- A J.D. from an accredited law school
- Admission and membership in good standing to the bar of at least one State
- At least 6 years of relevant legal experience, including at least two years of pharmaceutical or biotech experience
Preferred Qualifications:
Candidates with the following additional experience/qualifications are highly desired:
- At least 4-5 years of experience providing advice and support in a pharmaceutical or biotech company
- Experience identifying various regulatory issues, with a focus on False Claims Act, healthcare fraud and abuse laws and FCPA/UK Bribery Act
Competencies/conduct:
In addition to the minimum qualifications, the employee will demonstrate:
- A high degree of professional ethics and integrity.
- The agility and disposition to positively deal with change.
- Excellent judgement and the ability to operate in a fast-paced, high-performing small legal department.
- A track record of successfully working independently as well as collaboratively in a team context.
- Outstanding verbal and written communication skills.
- Excellent analytical and problem-solving skills.
- The ability to effectively manage time, prioritize responsibilities, and work efficiently.
- Strong business partnership skills.
- High positivity and resiliency and adherence to our guiding principle “Believe that people's actions are well intended”.
- Digital dexterity (i.e., Word, Excel, PowerPoint, etc.)