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Melinda Burrows
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Energy Service Company
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Senior Corporate Counsel
Refer job# QSWD135668
 
Senior Corporate Counsel The candidate will report to the Assistant General Counsel. Will provide legal support for one or more firm's products within the firm's Genzyme specialty care business unit of firm's, focusing on rare disease and oncology. 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 firm's 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 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. 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 firm's Legal Group, including coordination of global legal support relating to the firm's Genzyme business unit.

The candidate should have JD degree from an accredited law school. Good standing in the Bar admission of MA is essential. Should have 5+ years of post-J.D. experience, preferably including both in a law firm and in-house, in the pharmaceutical, biotechnology, or medical device industry. Should have 5+ years of relevant pharmaceutical industry experience including counseling in-house clients on the sale and marketing of approved products. 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 essential. 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 is essential. Should have knowledge of FDA drug and medical device requirements and submission processes, knowledge of FDA promotional, advertising, and labeling requirements and processes for drugs; Strong verbal and written communication skills is essential. Experience participating in promotional review board is preferred. Experience working in a matrix, international environment is preferred. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company is preferred. Strong contract drafting and negotiation skills is essential.
 
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