- Experienced attorney with 10+ years of relevant pharmaceutical industry experience including counseling in-house clients on the sale and marketing of pharmaceutical products to join the Sanofi Legal Department as Senior Corporate Counsel. 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) 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, regulatory, and compliance, for the designated product(s) and the Global Business Unit focusing both on global and US issues. 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;
- 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 and acting as Legal Department representative on cross-functional teams, as assigned;
- 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.
Required Educational Background & Job-Related Experience:
Candidates for the position should have the following: Excellent academic credentials, including a J.D. from an accredited, highly respected law school, 10 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 and in good standing 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;
- A minimum of 10 years of post-J.D. experience, preferably including both in a law firm and in-house, in the pharmaceutical, biotechnology, or medical device industry;
- 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.
Demonstrated excellence in (i) understanding and digesting complex scenarios in order to identify and evaluate relevant issues and risks, (ii) propose solutions that take into consideration the relevant business objectives, and (iii) communicate those issues, risks, and solutions clearly and concisely to lawyers and non-lawyers alike;
- Appropriate management of legal risks in assigned client areas;
- Strong contract drafting and negotiation skills;
- 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; and
- Ability to effectively and efficiently manage outside counsel, when used, and adhere to a budget.
Lead Competencies & Behaviors:
Sanofi is a global company with an emphasis on cross-border and cross-functional cooperation; a team focused environment is the foundation of Sanofi's operating model. While extraordinary individual efforts are recognized and rewarded, ultimately one's success or failure is determined by how well the entire team does. That team spirit is the hallmark of the Sanofi legal division and advanced behaviors in teamwork and altruistic leadership are necessary.
- Demonstrates a deep understanding of trends and facts that impact our business.
- Defines and balances strategic priorities against immediate operational challenges.
Act for Change
- Creatively challenges the status quo to find new ways of working.
Strive for Results
- Sets ambitious, tangible and measurable targets.
- Takes personal responsibility for achieving his/her team results.
- Shares relevant information openly and seeks appropriate input
- Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business units.
- Makes decisions when needed; even if the outcomes are difficult or sensitive.
- Takes responsibility for decisions and accepts accountability for results.
Commit to customers
- Actively seeks customer feedback to identify opportunities for improvement and to gain insight to underlying needs.
- Understand, meet and exceed internal and external customer expectations to create positive impact.
- Actively works to gain genuine understanding of the customers' perspective.
Strives for continuous professional improvement, including a commitment to personal development and to actively engage with colleagues in support of their personal development.
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.
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