BD (Becton, Dickinson and Company) Assistant General Counsel - Regulatory in Franklin Lakes, New Jersey
Job Description SummaryReporting relationship
The Assistant General Counsel - Regulatory will be a member of the Regulatory Law Group. S/he will work closely with BD's Regulatory and Quality leaders..
The 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 including 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 compliance department.
Education / Certifications
• The successful candidate will hold a law degree with strong academic credentials from an accredited law school and will have obtained an undergraduate degree from a college or university of recognized standing.
• S/he will be licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States without any instances of suspension, revocation, censure or other adverse events in any jurisdiction, whether or not the candidate is currently admitted to practice in that jurisdiction.
• 7-12 years of relevant healthcare regulatory experience
• Ideally, s/he will have practiced at a well-respected law firm combined with having served in an in-house or FDA or other government regulatory role.
• Significant experience in FDA and other regulatory issues specifically related to medical devices and/or diagnostics throughout the lifecycle of the product, including development, approval and marketing
• Experience supporting RA and Quality leaders in navigating interactions with FDA regulators in a positive and collaborative manner during inspections, requests for additional information, recall activities, compliant handling, and throughout the submissions process.
• A superior ability to lead through influence and navigate controversial situations, and negotiations. A deep understanding of the FDA's regulatory and submission requirements, particularly with respect to devices, diagnostics, and combination products, with strong strategic, commercial and interpersonal skills.
• A commercially oriented attorney who understands the nuances of complicated regulatory issues and is well able to think creatively to mitigate risk while supporting business objectives.
• Ability to contemplate the legal implications of new innovations and collaborate with the business to develop regulatory strategies for new technologies.
• Superior writing skills with an ability to present nuanced, complicated, and content rich issues.
• Personally committed to BD’s Purpose and Core Values.
• Responsive, approachable and collaborative work style.
• Strategic thinking with a strong customer focus.
• Possesses a high degree of accountability, self-motivation and drive.
• Superior written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization.
• Professional demeanor and ability to interact at executive level with persuasiveness and confidence.
• An engaged team member and a desire to participate in a team-driven atmosphere and interface with external/internal parties.
• Demonstrated ease in developing relationships of trust and confidence both within and outside BD and an ability to be “other-oriented”; ability to appreciate people with different backgrounds and points of view and ability to create an inclusive environment.
• Unquestionable ethcs and professional judgment.
• Exceptional judgment and an ability to make hard decisions quickly, thoughtfully, and confidently.
• A solutions oriented lawyer with a “hands-on” energetic approach and style coupled with a strong work ethic.
• Commercially-minded underscored by keen attention to risk and ethics.
• Must be able to function well within a matrixed organization.
BD’s Core Values
We do what is right - We are committed to the highest standards of excellence and integrity in everything that we do: on behalf of our customer, our shareholders, our communities and ourselves. We are proud to work for a healthcare company whose products and services make a difference in people’s lives. We derive our greatest sense of accomplishment from doing what is right ― not what is expedient. We don’t compromise our high standards of ethics in order to achieve our objectives. We are reliable, honest and trustworthy in all our dealings. We keep our promises and if we make a mistake, we make it right.
We take personal responsibility - Change is never easy, and despite our best efforts, it won’t all go smoothly. Being individually responsible means we are accountable for our decisions, even when we make a mistake, and not try to place blame or make excuses. We treat the company's reputation as our own and try to make wise use of our time and the company's resources. We expect access to the tools and information necessary to participate in any decisions that will reflect on our collective or individual reputations.
We anticipate and address the challenges of patients and customers globally - It’s not enough to just respond to customer challenges. We need to know our customers’ needs as well or better than they do, so we can be proactive. Thinking about our customers holistically, including the patients they serve, will enable us to serve them better, helping to solve their most pressing healthcare challenges.
We innovate and improve continuously - Innovation isn’t specific to R&D and new product development, nor is continuous improvement limited to our operations and manufacturing teams. We are all accountable for seeking innovative solutions to our challenges and for not settling for “good enough” but striving to improve and be better every single time. We study our progress and learn from others and ourselves how to do things more effectively and efficiently.
We respect, collaborate, challenge and care about each other - We act with respect towards each other and towards those with whom we interact. We collaborate and challenge each other, cultivating best practices throughout the organization. We demonstrate constructive candor by disagreeing openly and dealing with our differences professionally. We care about people as individuals and promote an inclusive work environment that values, appreciates and leverages diversity.
Primary Work LocationUSA NJ - Franklin Lakes
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status