We are seeking an experienced attorney with at least 4 years of experience to join the Sanofi North America (NA) Legal Department. This position will support the US Market Access Shared Services and US Marketed Products organizations and reports to the Head of the US Market Access Legal team.
Key responsibilities are as follows:
- Counsel on drug price reporting and reimbursement issues, including advising on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting and transparency laws;
- Draft Centers for Medicare and Medicaid correspondence including letters and public comments on proposed rules and guidance;
- Develop price reporting compliance policies and reasonable assumption documents and advise on related internal training and audits;
- Lead internal legal resource on key industry market access policy issues, including pricing, reimbursement, authorized generics and payer innovations;
- Serve as the primary legal contact for assigned products and/or business units, acting as legal reviewer for advertising and promotional materials, as well as collaborating with other practice areas and functions relating to the assigned products and/or business units;
- Draft, negotiate, and review health care professional, vendor, licensing, consulting, speaker, advertising, sponsorship, and other agreements for commercial operations and medical affairs;
- Analyze product promotional initiatives, advisory board proposals, speaker programs, and medical education initiatives for FCPA, fraud and abuse, FDA, and other regulatory compliance;
- Advise on brand strategic planning and business operation plans;
- Review and advise on media relations materials including press releases, standby statements, Q&A documents, web sites and other company communications;
- Ensure that client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements;
- Work closely with internal teams to establish relationships and deliver consistent, practical legal guidance and support;
- Interact with and advise business leaders in the US concerning legal issues that have a direct effect on the success of the company.
- The Corporate Counsel operates with limited supervision, and therefore requires a high level of balanced judgment and an ability to independently discern and establish priorities. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are highly valued. Ability to identify potential legal issues (focusing on fraud and abuse, antitrust, promotional, and regulatory matters) as well as proposed solutions to mitigate risk is required.
Position will require travel primarily to Bridgewater, NJ and Cambridge, MA based on business needs. In addition, position may require occasional international travel based on business needs.
- At least 4 years of post-J.D. experience; and
- Licensed to practice law and in good standing in at least one US jurisdictionNJ or MA, a plus.
- Government price reporting experience a plus;
- Excellent academic credentials, including a J.D. from a highly respected, accredited law school;
- Broad based legal training, including exposure to payer arrangements, fraud and abuse (including the Anti-kickback Statute) and sophisticated regulatory and compliance issues.
- Experience working in a matrix, international environment; and
- Ability to provide and effectively communicate sound legal advice coupled with a strong understanding of business needs
- Demonstrated excellence in (i) understanding and digesting complex scenarios in order to identify and evaluate relevant issues and risks, (ii) proposing solutions that take into consideration the relevant business objectives, and (iii) communicating those issues, risks, and solutions clearly and concisely to lawyers and non-lawyers alike;
- Appropriate management of legal risks in assigned client areas;
- Sound judgment and commitment to ethical conduct;
- High level of professionalism;
- Strong interpersonal skills and ability to work collaboratively, with a solution-oriented approach, in teams within legal, business, and functional areas;
- Team player with a commitment to developing strong collaborative relationships with clients and cross-functional teams;
- Proven ability/interest in working across a broad range of subject matter areas;
- Commitment to proactively identifying opportunities for improvement and engaging with appropriate stakeholders to propose solutions;Self-motivated, able to work independently, reliable, responsive, and accountable;
- Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure;
- Working knowledge of US Federal and state healthcare compliance considerations;
- Ability to work independently and to be reliable, responsive and accountable;
- Ability to effectively and efficiently manage outside counsel, when used, and adhere to a budget; and
- Performs other duties as assigned.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.