Senior Counsel, US Commercial

TITLE:

Senior Counsel, US Commercial

Title: Senior Counsel, US Commercial

Reports To: Associate General Counsel

Location: Richmond, VA

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

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,