Sanofi Group Assistant General Counsel in Cambridge, Massachusetts
Experienced attorney with 12+ years of relevant pharmaceutical industry experience including counseling in-house clients on the development and commercialization of pharmaceutical products to join the Sanofi Legal Department as an Assistant General Counsel within the Sanofi Genzyme legal team. This position reports to the Head of Legal, Sanofi Genzyme, and is based in Cambridge, MA.
This position will provide legal support for one or more Sanofi products (including both approved products and investigational products) as well as the related franchise or therapeutic area within the Sanofi Genzyme specialty care business unit of Sanofi. This position will serve as the legal contact to internal groups including Commercial, Sales, Medical Affairs, Patient Advocacy, Regulatory, and Compliance, for the designated product(s) and the Global Business Unit focusing both on global and US issues, requiring collaboration with legal colleagues around the world. Key responsibilities are as follows:
Ensuring 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;
Ensuring thorough and comprehensive understanding of global business activities and operations, and serving as the Global Legal Representative on cross-functional leadership team(s) to provide timely and practical legal advice to GBU leaders;
Identifying and delegating appropriate matters to brand attorneys, and overseeing the timely completion of such matters;
Identifying and collaborating with appropriate legal colleagues around the world to ensure product information is known and legal issues are addressed locally for global products;
Ensuring consistent legal advice across the franchise, where possible, to operate efficiently and achieve business objectives and goals;
Collaborating with brand attorneys to identify and analyze legal risks and propose appropriate actions to secure compliance with relevant rules, regulations, and policies, including coordinating and assisting in securing legal counsel from other Sanofi attorney’s globally in support of the global business strategy;
Ensuring that interactions with health care professionals and patients comply with applicable legal requirements and company policies;
Interacting with and advising senior business leaders concerning legal issues that have a direct effect on the success of the company and support of compliant strategy execution;
Drafting, negotiating, reviewing and interpreting agreements associated with the business, including agreements with health care professionals, vendors, licensors, consultants and speakers, and advertising, sponsorship, and other agreements supporting the business;
Collaborating with brand attorneys in analyzing product promotional materials and initiatives, advisory board proposals, and speaker programs to ensure compliance with applicable FCPA, fraud and abuse, FDA and other regulations and company policies;
Collaborating with brand attorneys in analyzing medical education initiatives and programs and company scientific communications to ensure compliance with applicable laws, regulations and company policies;
Reviewing, analyzing and advising on promotional and medical materials;
Advising on brand/GBU strategic planning and business operation plans;
Advising on FDA regulatory submissions, label negotiations, publication support and medical affairs activities;
Reviewing and advising on media relations materials including press releases, standby statements, Q & A documents, web sites and other company communications;Advising Patient Advocacy to ensure interactions with patients and patient organizations comply with applicable legal requirements and company policies;
Ensuring that clients are kept abreast of all relevant legal developments in their areas of business;
Counseling and collaborating with the Compliance/Ethics and Business Integrity department on policy development, training, and other relevant activities;
Acting as Legal Department representative on cross-functional teams, as assigned; and
Coordinating with and supporting other members of the Sanofi Legal Group, including coordination of global legal support relating to the Sanofi Genzyme business unit.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life