The U.S. Pharmacopeial Convention (USP) Senior Counsel in Rockville, Maryland
Summary of the Position
The Senior Counsel provides legal and policy guidance for USP’s standards-setting activities related to drugs, dietary supplements, and excipients. The Senior Counsel will also be a partner and will assist and provide practical and strategic legal support for various programs at USP. The incumbent will perform relevant research and provide advice in the areas of food and drug federal and state laws, and other healthcare-related laws and regulations relevant to USP’s standards-setting activities and supporting programs. The incumbent will interact with internal and external stakeholders related to USP’s public health mission.
Roles and Responsibilities
Provides legal and policy support for USP’s program units and serves as a resource on food and drug laws and regulation and related healthcare laws and regulations.
Advises USP staff and Expert Committees on legal, regulatory and policy issues relating to compendial standards development; works on compendial-related issues and projects as directed by the Vice-President, Global Legal Affairs.
Keeps organization apprised of developments in law and regulations that may affect USP, particularly about: compendial standards; standards-setting practices and procedure; drug, food, dietary supplements and excipients.
Assists in the implementation and interpretation of USP policies and processes and developing Rules and Procedures governing the work of the Council of Experts, Expert Committees and related bodies; provide advice and resources to help assure compliance with policies and processes, particularly regarding conflicts and confidentiality.
Provide training to USP staff and expert volunteers on documentary standards development and governance legal issues affecting standards-setting activities.
Performs other duties as assigned.
Must possess a law degree from an accredited law school with a strong academic record and admittance to the bar.
At least 7 years required with specific experience navigating and providing advice on complex legal and policy issues related to food and drug matters.
Demonstrated skills in leadership, facilitation, and collaborative problem solving; strong interpersonal skills; demonstrated ability to work effectively in a matrix global organization.
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.
In-depth knowledge and understanding of food and drug regulatory issues; excellent research skills; familiarity with the global food and drug industry.
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.
USP offers an impressive benefits package , including:
Generous paid time off – 14 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Legal