Summary of the Position
This is a hands-on, highly technical position that supports the Dietary Supplements standard-setting activities. The incumbent is responsible for assisting in the development and revision of monographs, general tests and assays, and responding to internal and external queries related to monographs for dietary supplements in USP-NF. These activities require the critical evaluation of relevant documents and other information, the performance of literature searches on related topics, and the development and drafting of pertinent documents for other scientific staff and/or Expert Committee review. The incumbent recognizes when additional expertise is needed and he/she has the ability to put together and manage advisory panels. The incumbent also closely follows the work of other Committees so that collaboration and exchange of information is seamlessly accomplished and made available when needed. He/she establishes and maintains relevant contacts outside of USP, stays abreast of new findings, and informs other scientific staff of new developments in dietary supplement quality methodologies. Liaise between Expert Committee and interested parties from government, academia and industry on issues pertaining to standards for dietary supplements.
Roles and Responsibilities
- Evaluates and analyzes specifications and supporting data, development of standards in USP style and format.
- Develops, writes and guides research laboratory projects related to standards for dietary supplements.
- Writes general and specific correspondence pertaining to dietary supplement monographs, and dietary supplement general chapters.
- Assists in the development of agendas and planning for USP Expert Committee meetings, stimulate discussion between members of the Expert Committee, organize their work assignments and provides assistance and guidance.
- Promote the development of new standards and evidence-based reviews for Dietary Supplements.
- Communicates with other USP departments regarding projects related to validation studies, method development, reference standards development and evaluation.
Knowledge, Skills and Abilities
Able to establish and nurture relationships with individuals of varying backgrounds and learning styles. Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships. Strong presentation and communication skills (written and oral). Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills. Knowledge of internet and electronic database searches helpful. Practical experience in analytical techniques is required. Knowledge of the dietary supplement industry and the associated regulatory framework is essential. Ability to prioritize tasks and manage multiple projects simultaneously. Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from dietary supplement companies, government, and academic institutions.
Associate Scientific Liaison- PhD + 5 years or MS + 7 years.
Scientific Liaison- PhD + 8 years or MS + 10 years.
An equivalent combination of experience and education may be substituted.
Experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titrations, etc. is required. Experience in one of the following areas is desirable: pharmacology, pharmacognosy, pharmaceutics, or regulatory affairs.
US Pharmacopeial - 18 months ago