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Post : Senior Scientist II -Dietary Supplements and Herbal Medicines (Toxicology)
Job Description
The incumbent is responsible for developing new DS admission evaluations based on safety and toxicology evaluation and revising existing ones, collating information on nomenclature and labeling of dietary supplements, and responding to related internal and external queries.
These activities require performance of literature searches on topics related to safety, nomenclature and labeling of DS; critical evaluation of relevant documents and other information and drafting admission evaluations for other scientific staff and/or Expert Committee review.
The incumbent liaises with expert committee members in the critical review of information required for the admission of the proposed monograph articles to the USP-NF monograph development process. The incumbent is able to work independently but recognizes when additional expertise is needed and has the ability to put together and manage advisory/expert panels.
The incumbent will liaise with the Admission Expert Committee, other USP scientists, and interested parties from government, academia and industry on issues pertaining to safety, efficacy and nomenclature of dietary supplements and herbal medicines.
• Perform literature searches on clinical, toxicological, PKPD and regulatory opinion/information (EFSA opinions, GRAS, NDI, Self-GRAs documentation), analyzes and synthesize the literature data.
• Draft Admission Evaluations for the Admission EC to aid EC members in determining the admissibility of articles for monograph development.
• Make presentation related to admission evaluation to internal audience at USP and to external audience on behalf of USP.
• Writes general and specific correspondence related to safety, efficacy, nomenclature and labeling of dietary supplements proposed for USP monograph development.
• Collaborate with sponsors and other stakeholders (academia and regulatory agencies) to support the development of new Dietary Supplements admission evaluations.
• Assists in the development of agendas and planning for USP Expert Committee meetings, stimulates discussion between members of the Expert Committee, organizes work assignments and provides assistance and guidance to EC members.
• Support documentary standards scientists as needed, to determine specific markers to be included or excluded in the monograph based on safety attributes.
• Communicate with other USP departments regarding projects related to safety and labeling of dietary supplements and herbal medicines and dietary supplements admission evaluation.
• Work on special projects as needed.
Candidate Profile
Senior Scientist I
• PhD. in toxicology, pharmacology, pharmacognosy, pharmacy or a related field, and five (5) yrs. of relevant experience, or
• M.S in toxicology, pharmacology, pharmacognosy, pharmacy or a related field + seven (7) yrs. of relevant experience, or
• An equivalent combination of education and experience may be substituted
Senior Scientist II
• PhD. in toxicology, pharmacology, pharmacognosy, pharmacy or a related field + eight (8) years of relevant experience, or
• M.S. in toxicology, pharmacology, pharmacognosy, pharmacy or a related field + ten (10) yrs, or
• An equivalent combination of education and experience may be substituted
Preferred Qualifications
• Excellent written and verbal communication skills in English.
• Knowledge about GRAS determination and requirements for NDI notifications.
• Knowledge about natural products, their biological activities and safety profiles.
• Experience working on evaluation of safety and benefits of dietary ingredients and supplements.
• Knowledge of the U.S. dietary supplement industry and the associated regulatory framework.
• Ability to prioritize tasks and manage multiple projects simultaneously.
• Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Ability to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
• Well-developed organizational, interpersonal communications, negotiation, and strong listening skills.
• Strong presentation skills.
• Knowledge of internet and electronic database search strategies.
• Understanding of dietary supplements quality specifications.
Additional Information
Experience : 5+ years
Qualification : Ph.D, M.S.
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Dietary Supplements and Herbal Medicines (Toxicology)
End Date : 30th October, 2022
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