The U.S. Pharmacopeial Convention (USP) Deputy General Counsel, Standards in Rockville, Maryland
Summary of the Position
This is a key senior level position that oversees USP’s global legal affairs related to our scientific standards and their role in the global healthcare regulatory environment. The Deputy General Counsel, Legal Standards provides legal and policy thought leadership and guidance for USP’s scientific and standards-setting activities, with a particular focus on the policy and procedures to ensure transparency, consistency, scientific rigor, and utility/relevance to our varied stakeholders. He or she oversees a team of lawyers providing guidance on the strategic and operational choices that support USP’s legal recognition and responsibilities in the areas of Pharmaceutical, Dietary Supplement, and Food quality standards, as codified in U.S. federal and state law, as well as the laws and regulations of other countries.
The Deputy General Counsel, Standards will help set the long-term vision and policy for how USP will meet its legal responsibilities and leverage its role in law to further its public health mission in today’s rapidly changing global healthcare regulatory environment. He or she will provide legal and strategic advice to internal stakeholders on a broad range of issues under federal food and drug laws, state pharmacy laws, and other relevant health care-related laws and regulations, as well as issues involving USP’s standards-setting policies and processes. The incumbent will provide guidance on all legal/compendial issues with the USP Council of the Convention and Board of Trustees, and will lead on legal interactions with the Council of Experts, industry, regulators and other global stakeholders, to help advance USP’s scientific, standards-setting and other public health activities. He or she will collaborate closely with Deputy General Counsel, Global Corporate Legal Affairs to ensure common vision and guidance on issues of mutual concern. In addition, the Deputy General Counsel will represent Global Legal Affairs as part of several key decision-making bodies within the organization. He or she will be a key collaborator with the Global External Affairs and Global Science & Standards divisions.
Roles and Responsibilities
Continuously develops and maintains an enduring vision and proactive policy for USP standards, addressing evolving global regulatory environments and technologies, consistent with USP’s obligations in law and global mission
Provides legal and policy support for USP’s program areas (digital programs, training and technical assistance programs, standard setting in chemical medicines, biologics, foods and dietary supplements/herbal medicines, general chapters, and healthcare quality); supports other activities such as global public health programs, and research and innovation
Serves as lead internal expert on food and drug law and relevant laws relating to healthcare, , including the role of USP standards in law; keeps organization apprised of developments in health care, food and drug, and pharmacy laws and regulations and their implications for USP. Works closely with USP’s government and regulatory affairs group, providing key legal analysis and advice to support these activities.
Advises and counsels internal stakeholders and cross-functional teams on a variety of matters relating to food, drug, and healthcare law, as well as policy issues relating to USP’s standards-setting processes
Takes the lead on legal matters involving USP’s governing bodies , including the Board of Trustees and the Council of Convention.Works closely with the Council of Experts, including occasional presentations at Council of Experts, Expert Committee and Expert Panel meetings, working to ensure the integrity of the Council’s standard setting policies and processes and preserve and strengthen USP’s role in law.
Responds to subpoenas and other legal matters that implicate USP standards and governing structure (particularly Convention and Council of Experts)
Represents Global Legal Affairs, serving as a member of several key decision-making committees within USP.
Participates in global leadership strategy, policy, operations, and management meetings.
Serves as senior legal representative in external meetings and activities involving key stakeholders such as FDA, other regulatory authorities, industry, and practitioners, working to help build stakeholder relationships and collaboration and address stakeholder issues and concerns while protecting and advancing USP’s interests.
Manages, supervises and mentor junior lawyers working on compendial issues; ensures effective allocation of legal resources devoted to scientific and standards-setting areas.
Collaborates and coordinates with Corporate Legal Affairs to ensure development and execution of integrated legal strategies and approaches for the organization.Mentors others throughout the organization
Education and Experience:
Must possess a law degree from an accredited law school with a strong academic record and admittance to the bar.
Bachelor’s degree required in relevant field (public policy, engineering or science).
Professional experience of not less than 10 years in the areas of administrative and/or regulatory law, or similar.
Three (3) years independent workload management and team workload coordination
Three (3) years of team leadership experience
Prior in-house experience, ideally in a science- or healthcare- based industry.
Experience navigating and providing advice on complex legal and policy issues in a global regulatory environment
Experience in food and drug law, administrative law, corporate governance, or regulatory policy or compliance development, training, and/or enforcement
Demonstrated skills in leadership, facilitation, and collaborative problem solving; strong interpersonal skills.
Excellent judgment, particularly in determining the significance and implications of legal matters, effectively measuring risks, and evaluating legal and policy issues within a broader strategic context.
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs and advance organizational objectives.
Familiarity with food and drug industry and other standards-setting organizations.
Ability to work autonomously yet liaise effectively with cross-functional scientific and business teams; can prioritize and manage multiple time-sensitive projects simultaneously in a fast-paced environment.
Excellent communication skills, both written and oral, with ability to break down complex legal issues for clients throughout the organization at different levels of responsibility and communicate clearly and concisely.
Ability to assume highly technical and complex projects, create and present a plan of action, and independently drive project to favorable resolution or conclusion.
Senior Counsel, Standards
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Executive
Job Type Full-Time