The U.S. Pharmacopeial Convention (USP) Assistant Counsel in Rockville, Maryland
Summary of the Position:
This primary function of this position is to provide legal and policy guidance for USP’s standards-setting activities. Assistant Counsel assists and provides practical and strategic legal support for other initiatives and programs at USP, including (on a limited basis) corporate programs. The incumbent performs relevant research as directed and provides advice related to food and drug law and other healthcare-related laws and regulations relevant to USP’s standards-setting activities and supporting programs. The incumbent interacts independently with internal and external stakeholders. The incumbent is expected to have the judgment, maturity and skill to act with broad discretion in performing the responsibilities of the role.
Roles and Responsibilities:
Provides legal, regulatory, and policy support to USP and serves as a resource on food and drug laws and regulation and related healthcare laws and regulations.
Advises USP staff on legal, regulatory and policy issues relating to standards development; works on particular compendial-related issues and projects as directed by Senior Counsel.
Keeps organization apprised of developments in law and regulations that may affect USP, particularly with regard to drug, food, dietary supplements and excipients.
Assists in the development, implementation, and interpretation of USP policies and processes related to standard setting; provide advice, resources and training to help assure compliance with policies and processes particularly regarding conflicts and confidentiality.
Develops an understanding of and familiarity with USP, its people, products, markets, facilities, and customers..
Coordinates USP’s response to subpoenas and litigation at the direction of Senior Counsel.
Provides support to Counsel (Corporate) on as needed basis.
Establishes rapport and a working relationship with management and staff at all levels to encourage and continue the proactive use of in-house legal counsel.
Performs legal research and develop policies on a wide-variety of issues.
Performs special assignments or projects as assigned by other members of the Legal team.
Must possess a law degree from an accredited law school with a strong academic record and admittance to the bar.
Minimum of 1-3 years of demonstrated, broad legal and regulatory experience, gained with a law firm, government agency, or preferably as in-house counsel.
Demonstrated skills in facilitation and collaborative problem solving; strong interpersonal skills; demonstrated ability to work independently and effectively in a matrix 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 food and drug industry as well as other standards-setting organizations.
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 – 13 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.
Rockville, Maryland, United States
Job Category Legal