Associate Director Legal Regulatory

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Associate Director, Legal Regulatory
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 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.

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