- Understand the strategic and tactical objectives of the commercial team and develop creative and thoughtful solutions to key initiatives, taking into account current legal and regulatory landscapes, company policies and procedures and the current and future needs of the company.
- Focus on a broad range of legal, regulatory and compliance issues, including False Claims Act, Kickback Statute, OIG guidance, and the PhRMA Code, and will require cross-functional collaboration.
- Partnering with the business on assigned projects to evaluate and counsel on both tactical and strategic matters; identifies legal issues related to assigned matters; develops alternative solutions and facilitates the implementation of resolutions.
- Timely responds to and identifies solutions for day-to-day questions raised by clients.
- Keeps informed of new laws, regulations, and industry trends affecting the company.
- Providing legal advice and business counsel on innovative marketing and sales strategies, activities and programs, including review of advertising and promotional strategies and materials, and digital and social media initiatives, and working with clients to develop appropriate and compliant strategies for interacting with healthcare providers and other stakeholders.
- Supporting the Managed Markets operations, this attorney will: i) focus on specific issues related to the managed care market place, including relationships with PBMs, GPOs, group medical practice, etc.; ii) draft, negotiate and provide tactical and strategic advice regarding commercial contracts, with particular emphasis on managed markets agreements, particularly in the “buy and bill” area and (iii) advise his or her internal clients on various programs in a way that advances the company’s strategy while addressing legal/regulatory risks and preserving/protecting the company’s integrity and reputation.
Key Performance Indicators
- Detail-oriented, high-energy, and self-sufficient – driving projects to completion independently with the utmost integrity.
- Produces high quality work with minimal oversight.
- Possesses a ‘can-do’ attitude and the ability to work collaboratively with internal business partners.
- Handles confidential matters with discretion and judgment.
- Manages workload and work product efficiently and in a solution-oriented manner.
Knowledge and Skill:
- Health law expertise (FDA regulations and guidances; federal and state kickback laws; the prohibition against off-label promotion; FCPA; False Claims Act) to advise the business.
- Knowledge of the managed markets/payer industry, such as PBMs, rebate agreements, specialty pharmacies and related payer groups, as well as Medicare.
- Experience with government price reporting preferred.
- Exceptional written and verbal communications skills – able to effectively collaborate and communicate with stakeholders throughout the company.
- Excellent time management skills with proven ability to work on multiple projects at any given time in a fast-paced, nimble environment.
- Excellent organizational, decision-making and problem-solving skills.
- Ability to exercise initiative and sound judgment.
5-7 years of relevant commercial pharmaceutical industry experience with a major pharmaceutical corporation or law firm strongly preferred