Job Description: SummaryThe successful candidate will be a core member of BD's legal team helping drive the Company's mission, protecting the Company, and serving as a trusted advisor and strategic leader within the department and the Company. S/he will provide both strategic and tactical support and will serve as a strategic legal partner to BD's Regulatory and Quality teams. S/he must have the ability and desire to serve as a recognized thought leader within and outside of BD in the legal and regulatory arenas.
This is a unique opportunity for an individual to serve as a trusted advisor and commercially astute business partner who will collaborate effectively across the Company to assist the Company in meeting business objectives while ensuring regulatory compliance and mitigating risk. The position requires an expert level of understanding of legal-regulatory implications of business decisions enterprise-wide and will play a significant role in enabling the Company and its professionals to deliver services effectively and efficiently, while appropriately managing risks in the heavily regulated environments in which the Company operates. S/he is ultimately responsible for facilitating the business objectives of the Company by providing timely and effective legal support, as well as minimizing potential legal exposure and risk. The successful candidate will be a "hands-on" attorney who is able to run autonomously yet operate in a global business.
This position has direct client contact at the business unit leadership level and the corporate senior leadership level. The successful candidate will have the opportunity to make an immediate contribution to BD's continuing growth and success. The person sought for this role will be a proven, high potential candidate with strong intellectual and technical skills and successor qualities and attributes.
Provide legal counsel to clients throughout the organization on a variety of regulatory and quality matters, including pre-market approval and post-market surveillance, as well as product issues and other business matters. Provide expert advice and counsel to businesses concerning complex regulatory matters and issues germane to the business with a focus on FDA issues enterprise wide. Primary clients include Regulatory, Quality, Sales and Marketing, R&D, and Medical Affairs.
Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on FDA issues
Ensure high quality legal advice is provided to business clients; proactively identify trends (legal/business); participate as a strategic partner with client groups and stakeholders.
Maintain knowledge of FDA law and regulation changes and enforcement actions in order to maintain the highest level of expertise
Proactively advise on legal risks related to business activities, develop solutions to mitigate risk and influence key business leaders.
Support regulatory due diligence for new business and product acquisitions.
Manage activity and reporting required by an existing consent decree.
Provide day to day legal advice and oversight to a variety of constituents including management, customers and governmental officials on a range of regulatory matters.
Understand and be able to translate into "plain English" the legal ramifications of varied legal and regulatory and clearly and succinctly articulate the risks.
Support Quality and Regulatory Affairs with the development of policies, procedures, and training programs to ensure that FDA regulations and other regulatory best practices are reflected in the Company's business activities.
Assure proper resource planning and manage outside counsel.
Work closely with the Ethics and Compliance department.
Primary Work LocationUSA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)