Senior Corporate Counsel
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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Experienced attorney with 7+ years of relevant pharmaceutical industry experience including counseling in-house clients on the sale and marketing of approved products to join the Sanofi Genzyme Legal Department as Corporate Counsel. This position reports indirectly to the Head of Legal, Sanofi Genzyme, and is based in either Cambridge or Waltham, MA.
This position will provide legal support for one or more Sanofi products within the Sanofi Genzyme specialty care business unit of Sanofi, focusing on the rare blood disorder franchise. This position will serve as the legal contact to internal groups including commercial, sales, medical affairs, regulatory, and compliance, for the designated product(s) and the Global Business Unit focusing both on global and US issues.
- 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;
- Identifying and analyzing legal risks and proposal of 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;
- Analyzing product promotional materials and initiatives, advisory board proposals, speaker programs, and medical education initiatives for FCPA, fraud and abuse, FDA, and other regulatory compliance;
- Advising on brand/GBU strategic planning and business operation plans;
- Advising on FDA regulatory submissions, label negotiations, publication support and medical affairs activities including sitting as a member of the Medical Affairs review committee;
- Reviewing and advising on media relations materials including press releases, standby statements, Q & A documents, web sites and other company communications;
- 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;
- Coordinating the legal aspects of client projects;
- Contributing to the achievement of clients’ business objectives;
- Acting as Legal Department representative on cross-functional teams, as assigned;
- Coordinating with and supporting other members of the Sanofi Legal Group, including coordination of global legal support relating to the Sanofi Genzyme business unit.
Candidates for the position should have the following: JD required, 7 or more years of experience working in private practice and/or in-house within the pharmaceutical industry, experience with counseling business leaders, and a strong understanding of the business and legal challenges that impact the pharmaceutical industry. Licensed to practice in MA.
The successful candidate will possess the following attributes:
- Substantive working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including without limitation the US Federal healthcare program requirements under the Food, Drug and Cosmetic Act (“FDCA”), False Claims Act, the Anti-Kickback Statute, and the Transparency Provisions of the Patient Protection and Affordable Care Act (the “Sunshine Act”).
- Experience working with pharmaceutical, biotechnology, or medical device industry marketing (advertising, promotion, labeling) and sales issues, including FDA promotion, anti-kickback, and fraud and abuse matters.
- Knowledge of FDA promotional, advertising, and labeling requirements and processes for drugs;
- Knowledge of FDA drug and medical device requirements and submission processes;
- Experience participating in promotional review board preferred;
- Excellent academic credentials, including a J.D. from a highly respected, accredited law school;
- Good standing in the bar of MA;
- Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company preferred;
- Experience working in a matrix, international environment preferred;
- Strong verbal and written communication skills; and
- Ability to provide and effectively communicate sound legal advice coupled with a strong understanding of business needs.
- Position may require travel to various sites domestically or internationally as needed.
- Excellent academic credentials, including a J.D. from an accredited, highly respected law school, with a minimum of 7 years of relevant post-J.D. experience, preferably including both law firm and in house experience in the pharmaceutical, biotechnology, or medical device industry.
Sanofi US Services, 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.
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