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 an Assistant General Counsel Regulatory in Northrbook, 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 Sales and Marketing, Regulatory Affairs, Clinical R&D, Pharmacovigilance, Compliance, Corporate Communications, Quality Assurance, Government Policy, Health Systems, Medical and Scientific Affairs and Medical Information. While keeping manager appropriately informed, independently provides leadership on cross-functional teams, identifies legal issues, provides legal options and analysis of possible legal solutions, and gives recommendations for addressing critical issues so that business and legal objectives are met. Advises and consults with employees, and managers and senior management, and educates clients on proactive measures.
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:
Reviews, analyzes and keeps current on federal and state and international legal developments, affecting the pharmaceutical industry, and advises clients accordingly, including without limitation FDCA, PDMA, OIG Guidance, PhRMA Marketing Code and Fraud and Abuse Issues and Anti-Bribery and Anti-Corruption. Assists in supporting the launch, sale and marketing of company proprietary prescription products by providing legal advice, including the legal interpretation of rules, regulations and guidance documents relating to the promotion, advertising, discounting and reimbursement for pharmaceutical products.
Provides legal support, including day to day counseling, to clients on legal issues affecting each of the departments and units noted above.
Represent Legal department on various cross-functional committees.
Conducts internal investigations, as necessary, with minimal supervision and recommends appropriate company response.
Manages company response to government inquiries and investigations, as necessary.
Manages outside counsel effectively and efficiently, and consistent with applicable budgets. Works creatively with outside counsel to minimize fees and costs.
Performs special projects as assigned and demonstrate leadership ability on a wide range of issues.
May manage legal staff and support staff.
Overnight Travel as needed
Responsible for operating within the Legal budget, and any applicable project specific budgets.
Reports to the Vice-President, Chief Regulatory Counsel, or delegate, within the Legal Department.
Juris Doctor required and licensed to practice law.
Minimum of 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.
Demonstrated awareness and understanding of the Company's global structure. Interacts with global headquarters in Japan and with European headquarters.
Ability to independently and effectively provide leadership to cross-functional teams and to deliver legal presentations to various committees.
Solid understanding of the legal issues affecting the pharmaceutical industry, including US regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws. Working to develop knowledge of ex-US regulatory environment that affects decision-making in the US and Astellas' global business. Knowledge and understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory and commercial elements.
Fosters business process improvements.
Licensed to practice law in Illinois.
10 years related experience in corporate legal department or law firm 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.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Astellas Pharma US, Inc.