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Corporate - General Attorney in Cambridge, MA

Genzyme Corporation Jun 30,2017 Apr 17,2017 Location USA Cambridge MA
This job is expired...

In-House

Attorney

Corporate - General

Min 15 yrs required

Profile

Associate General Counsel The candidate will be overseeing and mentoring corporate counsel and/or senior corporate counsel supporting the rare disease and oncology areas of the Sanofi Genzyme business and providing direct legal support to the business. Will be 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, including sharing business strategies and objectives with global legal teams and ensuring alignment where appropriate among Sanofi global business units. 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 global strategic planning and business operation plans. Advising on FDA regulatory submissions, label negotiations, publication support and medical affairs activities including sitting as 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 department on policy development, training, and other relevant activities. Coordinating the legal aspects of client projects within the Sanofi Genzyme legal group and throughout the Sanofi Legal, Ethics and Business Integrity function (LE&BI), working across the LE&BI function to ensure timely and appropriate input is obtained to support the business unit’s global strategy and objectives. 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, and ensuring that appropriate information is shared globally through LE&BI to support achievement of the global business unit’s priorities. JD degree from an accredited law school is needed. Good standing in the Bar of MA is essential. Should have 15+ years of post JD experience. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company are preferred. Experience working in a matrix, international environment is preferred. Should preferably have including both in a law firm and in-house, in the pharmaceutical, biotechnology, or medical device industry. 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”) is needed. 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 are essential. Knowledge of FDA drug and medical device requirements and submission processes are advantageous. Knowledge of FDA promotional, advertising, and labeling requirements and processes for drugs are beneficial. Must have strong verbal and written communication skills. Understanding and digesting complex scenarios in order to identify and evaluate relevant issues and risks is needed.

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