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Astellas Pharma Associate Director, Legal Regulatory in Northbrook, Illinois

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 Associate Director, Legal Regulatory in Northbrook, IL.

Purpose & Scope:

The Associate Director, Legal Regulatory is a key legal advisor 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 practical, timely, and high-quality legal support, as well as minimizing potential legal exposure and risk.

This is a strategic position and is accountable for balancing global opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment. This position is also accountable for proactively identifying and mitigating risks to the Company's ability to achieve its corporate objectives under the Corporate Strategic Plan ("CSP").

Essential Job Responsibilities:

The Associate Director, Legal Regulatory will have the following responsibilities, working closely with the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development and the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development):

  • Serves as a strategic legal partner to global functions by providing a full range of timely, proactive, strategic, best-in-class legal advice and support, taking into account the global objectives of the organization, the CSP, and the varying regional and local legal and regulatory requirements to effectively minimize and mitigate risk, with minimal supervision.
  • Regularly researches and benchmarks, on a global basis, evolving legal and regulatory developments and industry standards and codes affecting the pharmaceutical and device industries to identify enforcement risks and trends, propose risk mitigation strategies, and update business clients, coordinating with other leaders in the Legal function as may be appropriate.
  • Acts as a one-stop source for global advice and counsel for strategic business initiatives.
  • Serves as point person for digital health-related legal regulatory and legal compliance advice.
  • Provides legal support for Astellas' interactions with healthcare providers (including speaker programs, consulting, and advisory boards).
  • Reviews and approves brand plans, strategic planning materials, product labeling, and promotional materials (including direct-to-consumer advertising and sales training materials) for designated products.
  • Advises Corporate Social Responsibility regarding funding efforts.
  • Serves as legal advisor to Independent Medical Education team.
  • Develops strategy for providing legal advice to global, enterprise-wide projects and initiatives through creation and deployment of business-specific guidelines, controls, and processes.
  • Regularly meets with business leaders and participates in and provides advice for strategic business projects/initiatives.
  • Aligns and coordinates with other members of the Legal and IP Legal teams, as well as Ethics & Compliance, to build global policies and processes to ensure efficient legal review of business objectives.
  • Performs special projects as assigned and demonstrate leadership ability when helping the company to analyze innovative approaches.
  • Represents the Legal department on various cross-functional committees.
  • Partners with a global team of highly skilled and specialized lawyers and other professionals in multiple jurisdictions to assure timely, proactive, strategic and high-quality legal advice
  • Coordinates with Centers of Excellence in the General Counsel group as may be appropriate or needed.
  • Supports a legal culture of excellence within his/her team which includes driving and fostering: (1) an agile, adaptive culture; (2) a value-based organization based on Legal's Mission and objectives; (3) a culture of innovation, transparency and trust; (4) proactive identification/mitigation of risk in a balanced approach; (5) empowerment and engagement of the team members; (6) a collaborative culture with close coordination with other members of Legal and IP as appropriate to leverage synergies and efficiencies; (7) a culture of compliance and good corporate governance; and (8) a continuous expectation of high performance, where "ok" is not good enough.
  • Leads other projects as may be requested by the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development); Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development; Legal Head of CRMD; or General Counsel.
  • Overnight travel, including international travel, as needed.

Organizational Context:

  • The Associate Director, Legal Regulatory reports to the Senior Director, Legal Regulatory.
  • Provides a broad spectrum of practical, timely, and high quality legal services from a regulatory and legal compliance perspective to functions within Astellas, both U.S. and global, which include: Patient Centricity, Regulatory Affairs, Ethics & Compliance, Rx+, Sales and Marketing, Commercial Strategy & Capabilities, Global Market Access, Medical Affairs, Development, Pharmacovigilance, Quality Assurance, Health Systems, Corporate Communications, and Policy & Government Affairs.
  • Develops training and educates clients on proactive measures to mitigate legal risks.
  • Works closely, collaborates, and coordinates with other teams reporting into the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development as well as the other teams reporting into the Legal Head of Commercial, Regulatory and M&D ("CRMD").

Qualifications:

Required

  • Law Degree (Juris Doctor and licensed to practice law).
  • At least 5-7 years' experience working in a law firm or legal department of a pharmaceutical or medical device company.
  • Prior legal experience handling regulatory counseling matters for a company in the pharmaceutical or device industry.
  • Extensive background in applying fraud and abuse principles to business strategies.
  • Deep understanding of the legal issues affecting the pharmaceutical and device industries, including regulatory processes for prescription drugs and devices and fraud and abuse principles.
  • High level of comfort with researching global legal issues and synthesizing findings into clear, actionable advice.
  • Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision making skills, exercise sound judgment and provide practical and constructive legal advice.
  • Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Inspires trust and confidence through effective communication and interpersonal skills.
  • Strong work ethic and ability to manage large workload, multi-task and focus on critical priorities and otherwise effectively meet client needs. Ability to produce high-quality work under deadline pressures.
  • Team player and able to build relationships both internally and externally.
  • Strong organization and teamwork skills. Detail oriented, self-motivated and able to motivate others.
  • A strong commitment to integrity and professionalism and demonstrated passion for excellence.

Preferred

  • Background in digital health is a plus.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Legal

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