Senior Corporate Counsel (Lexington)
Compensation: $157,450.00 - $157,450.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
Major tasks and responsibilities will include: Ensures that client operations are in compliance with applicable laws and company policies. Identifies and analyzes legal risks. Proposes actions to secure compliance with relevant rules, regulations, and policies. Coordinates and assists in securing legal counsel from other company attorneys globally in support of the global business strategy. Ensures that interactions with health care professionals and patients comply with applicable legal requirements and company policies. Advises senior business leaders in regards to legal issues that have a direct effect on the success of the company and support of compliant strategy execution. Drafts, negotiates, reviews and interprets 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. Analyzes product promotional materials and initiatives, advisory board proposals, speaker programs, and medical education initiative. Advises on brand and Global Business Unit strategic planning and business operation plans. Advises on FDA regulatory submissions, label negotiations, publication support and medical affairs activities. Reviews and advises on media relations materials and company communications such as press releases, standby statements, Q&A documents, web sites. Ensures that clients are kept fully informed of all relevant legal developments in their areas of business. Advises and collaborates with the colleagues on policy development, training, and other relevant activities. Coordinates the legal aspects of client projects and acting as Legal Department representative on cross-functional teams, as assigned. Contributes to the achievement of clients business objectives. Acts as Legal Department representative on cross-functional teams, as assigned. Coordinates with and supports other members of the company Legal Group, including coordination of global legal support relating to the business unit.
We seek candidates with the following qualifications: Must have excellent academic credentials, including a J.D. from a highly respected, accredited law school. Requires a minimum of 10 years of post-J.D. experience. Experience both in a law firm and in-house, in the pharmaceutical, biotechnology, or medical device industry, highly preferred. Must have 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). Requires experience working with pharmaceutical, biotechnology, or medical device industry marketing and sales issues. Knowledge of FDA promotional, advertising, and labeling requirements and processes for drugs required. Knowledge of FDA drug and medical device requirements and submission processes required. Experience participating in promotional review board highly preferred. May require travel to various sites domestically or internationally as needed. Must have demonstrated excellence in understanding and digesting complex scenarios in order to identify and evaluate relevant issues and risks. Requires the ability propose solutions that take into consideration the relevant business objectives, and communicate those issues, risks, and solutions clearly and concisely to lawyers and non-lawyers alike. Strong contract drafting and negotiation skills required. Must have sound judgment, commitment to ethical conduct, and a high level of professionalism. Requires the ability to effectively and efficiently manage outside counsel and adhere to a budget.
Associated topics: antibody, clinical, diet, drug, drug discovery, healthcare, metabolism, nutritionist, physiologist, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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