Title: Assistant General Counsel, North America
Reports To: General Counsel, Commercial
Location: Richmond, VA (relocation offered)
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication – as well as related mental health disorders such as schizophrenia.
POSITION SUMMARY: Indivior, a global specialty pharmaceutical company dedicated to pioneering life-transforming treatments in the field of addiction, is seeking an Assistant General Counsel, North America to focus on providing effective legal advice and counsel in connection with pre-launch, launch, and post-launch commercial initiatives. This position will be based in Richmond, VA and will work closely with Indivior’s Commercial, Global Strategy, Medical Affairs, Regulatory, Clinical and other related departments.
The responsibilities of this job include, but are not limited to, the following:
- Serving as legal advisor to the Commercial, Global Strategy, Medical Affairs, Regulatory, Clinical and other related departments in connection with the design and evaluation of pre-launch, launch, and post-launch commercial initiatives.
- Providing high quality and timely legal advice and counsel to the Commercial, Global Strategy, Medical Affairs, Regulatory, Clinical and other related departments.
- Analyzing business and commercial initiatives and providing advice and counsel on applicable laws and regulations, including but not limited to antitrust, commercial, false claims/anti-kickback, fraud and abuse, and other related healthcare compliance laws, regulations and requirements.
- Providing legal advice and business counsel on innovative business, commercial, and development strategies, including but not limited to marketing and sales strategies, activities and programs, review of advertising and promotional strategies and materials, and working with clients to develop appropriate and compliant strategies for interacting with external parties.
- Providing legal advice and counsel on market access, pricing, reimbursement, government pricing matters including but not limited to price reporting, federal contracting requirements, pricing and reimbursement advice, Medicare (Parts B and D), Medicaid and other Public Sector Reimbursement Programs (e.g., 340B, DoD, VA), commercial contracting, specialty pharmacy and specialty distributor matters, and GPOs
- Partnering with other members of the Legal, Governance and Compliance and other departments on statutory, regulatory and policy interpretation, and assist in providing related advice, counsel, training and other related activities.
- Providing legal advice and counsel on matters related to the development of access services, patient support and assistance programs, and educational materials.
- Drafting, reviewing and negotiating a variety of contracts including, but not limited to, master service, consulting, vendor, market research and trade related agreements.
- Assisting with special projects as assigned by the Chief Legal Officer.
Education: Juris Doctor and an active license to practice law in the US (in good standing) is required
- 10-15 years of experience as an attorney in the pharmaceutical or biotech industry
- Extensive knowledge and experience in commercialization of products and new products in all phases including pre-launch, launch, and post-launch, as well as branding, promotion and ensuring compliance with applicable laws, rules and regulations
- Knowledge of, and experience with, FDA regulations applicable to the pharmaceutical industry
- Extensive experience drafting and negotiating contracts
- Experience with dealing with controlled substances, risk mitigation programs, REMS and non-REMS products
- Approximately 10%-15%
In addition to the minimum qualifications, the employee will demonstrate:
- Ability to build consensus with diverse stakeholders and third parties and form strong, collaborate working relationships with clients.
- Experience managing a significant number of projects simultaneously and to thrive in a dynamic and fast paced environment.
- Demonstrated ability to proactively identify and resolve problems.
- Excellent judgment and ability to work independently and as a team to manage various tasks and simultaneously balance competing priorities to meet tight deadlines.
- Ability to collaborate with individuals throughout the company and outside counsel in a professional and business-like manner and in a results-oriented environment.
- Ability to work in a highly confidential environment with the highest standards of ethics and professional integrity.
- Excellent interpersonal, written and oral communication skills.
- Keen ability to define risk and be able to appropriately communicate those risks to internal decision makers for collaboration and resolution.
- Global/International product launch experience
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY