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Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Corporate Attorney Regulatory opportunity in Northbrook, IL.
Purpose & Scope:
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 & 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.
Essential Job Responsibilities:
* 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 Astellas' 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.
* Travel as needed.
Responsible for operating within the Legal budget, and any applicable project specific budgets.
This position reports to an attorney. This position may have one or more direct reports.
* Juris Doctor and license to practice law.
* Minimum of 5-7 years related experience in corporate legal department or law firm.
* Strong negotiation, oral and written communication, presentation, training, organizational, and teamwork skills required.
* Self-motivated, innovative, strategic, detail-oriented and able to provide high quality and timely work product. Able to manage multiple projects and work successfully in a fast paced environment under time deadlines.
* Works independently with minimal supervision.
* Ability to analyze regulatory issues and to discuss options and recommended course of action.
* Ability to effectively interact with global headquarters in Japan and with European headquarters. Understands the Company's global structure.
* Ability to effectively deliver legal presentations to internal groups to train and educate.
* Strong knowledge and understanding of the pharmaceutical industry.
* License to practice law in Illinois.
* 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.
* Knowledge of e-discovery and document preservation obligations.
Internal Number: 1850043936
About Astellas Pharma USA, Inc.
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created Changing Tomorrow Day, an annual, worldwide volunteer event, to demonstrate this commitment.