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Years of Experience
Date Last Verified
ProfileSenior Corporate Attorney Regulatory The candidate is responsible for providing practical, timely and high quality legal services in the regulatory area which covers a broad spectrum of support to Patient Experience, Regulatory Affairs, Compliance, Sales and Marketing, Clinical R&D, Pharmacovigilance, Quality Assurance, Health Systems, Corporate Affairs, Medical and Scientific Affairs and Medical Information. Advises and consults with employees and managers, and educates clients on proactive measures and approaches with respect to each of the above mentioned functional units. Responsible for identifying issues, analyzing possible legal solutions, and recommending options to address critical issues. The ultimate responsibility of this position is to facilitate the business objectives of the company by providing timely and effective legal support to each of these functions, as well as minimizing potential legal exposure and risk. Reports to an attorney. Provides legal services and counseling to the company's business on a broad array of complex issues in the prescription drug regulatory area for Patient Experience, Regulatory Affairs, Compliance, Sales and Marketing, Clinical R&D, Corporate Affairs, Medical Affairs and Medical Information, with minimal supervision. Reviews, analyzes and keeps current on federal and state legal developments affecting the pharmaceutical industry and advises clients accordingly, including OIG Guidance, PhRMA Marketing Code and Fraud and Abuse issues. Works closely with Compliance and Government Affairs (both Federal and State) and Corporate Communications. Assesses risks and advises clients as needed. Works collaboratively and creatively with all business units and provides broad spectrum legal support, including day to day counseling, on regulatory issues and corporate processes. Provides legal support for firm' interactions with healthcare providers (including speaker programs, consulting, and advisory boards). Reviews and approves promotional materials, including direct to consumer advertising, and sales training materials for designated products. Perform special projects as assigned and demonstrate leadership ability on a wide range of issues. Manages in-house and outside counsel to work in a timely and cost-effective manner. Interfaces directly with outside counsel on budgetary issues (including preparation and management of budgets and forecasts) to minimize fees and costs to resolve issues effectively. Responsible for operating within the Legal budget, and any applicable project specific budgets.
Qualification and Experience
The candidate should have Juris Doctor degree and license to practice law. Must have 5-7 years of related experience in corporate legal department or law firm. Strong negotiation, oral and written communication, presentation, training, organizational, and teamwork skill is required. Strong knowledge and understanding of the pharmaceutical industry is essential. License to practice law in Illinois is preferred. Experience in working as in-house counsel in the prescription pharmaceutical industry, with experience in promotional material review, FDA-related issues and PhRMA Code compliance is preferred. Knowledge of e-discovery and document preservation obligations is essential.
Astellas Us, LLC
1 Astellas Wayq
Northbrook, IL 60062