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General Counsel Consulting

General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
immediately.

Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Corporate Counsel Job in Massachusetts > Corporate Counsel

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Corporate Counsel

Refer job# YIZT135046

Corporate Counsel Duties: Provide legal support for one or more products within the specialty care business unit, focusing on rare disease and oncology. 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 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 Sanofi Legal Group, including coordination of global legal support relating to the Sanofi Genzyme business unit. Qualifications: JD Degree from an accredited law school; Good standing in the bar of MA; 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; 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 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; and ability to provide and effectively communicate sound legal advice coupled with a strong understanding of business needs. Preferred: Experience participating in promotional review board; Experience working in a matrix, international environment; Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company; 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; Ability to effectively and efficiently manage outside counsel, when used, and adhere to a budget.

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