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.
About US Pharmacopeia
At USP, everything we do is in service of our mission to help protect and improve the health of people around the world. From the standards we create to the partnerships we foster, we continually work to build and reinforce a foundation that draws us closer to a world where everyone can be confident of quality in health and healthcare.
To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
USP envisions a world in which all have access to high quality, safe, and beneficial medicines and foods. USP approaches this vision with a sense of urgency and purpose, strengthened by its cadre of dedicated volunteers, members, and staff, and by working collaboratively with key stakeholders across the globe.
As the world gets smaller and more connected, quality issues affect everyone. Diseases travel. Drug resistance grows. Fake medicines kill. The foundation of quality we’re building helps address these and other global health issues. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we’re there working to protect the health of people all over the world.