C6, a subsidiary of Goldbelt, Inc., Goldbelt, Incorporated is an urban, Alaska Native, for-profit corporation with locations in Juneau, Alaska and Herndon, VA. Its primary purpose is to manage assets and to conduct business for the benefit of its shareholders, approximately 3,600 people, almost all of Alaska Native heritage. Goldbelt, Inc. is in search of a Senior Scientist IV located in College Park, MD..
Senior Scientist IV
This position will provide expertise in supporting ODSP for policy development and strategic management of the dietary supplement program, which includes guidelines, regulations, safety assessments, and compliance strategy. ODSP enforces the supplement provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education (DSHEA) of 1994, to help ensure the safe marketing and truthful labeling of dietary supplements. ODSP also consults on chemistry and toxicology research in dietary supplements; reviews, evaluates, and supports enforcement actions based on current Good Manufacturing Practices (cGMPs), labeling/claims violations, and violative ingredients; and reviews dietary supplement adverse event reports.
Provide support to ODSP in evaluating and enhancing the effectiveness of ODSP’s regulatory review processes, including the NDIN review process, and developing, where appropriate, opportunities for improvement
Compose and present a work plan with detailed project approaches, milestones and schedules that meet the needs of the Project Officer and COR.
Ability to communicate in an effective and timely manner.
Expertise in the regulatory requirements of new dietary ingredient (NDI) notifications and related issues, such as the qualifications as an NDI, submission and review processes of an NDI notification, the data and information needed to evaluate the safety of an NDI, etc.
Knowledge in the regulatory review processes of NDI notifications and relevant guidance/SOPs.
Ability to characterize and evaluate the effectiveness of the interactions between organization and notifiers throughout the review processes, identify the variable factors that influence the effectiveness, and propose approaches to improvement the effectiveness. Experiences in quantitative analysis and process standardization may be preferred.
Compose reports of the findings and advisory approaches.
Education and research experiences in toxicology, biochemistry, and statistics required
Minimum of 3 years working with regulatory review processes and regulatory requirements
Experiences in developing standard operating procedures (SOPs)
Knowledge in the regulatory review processes of dietary supplement ingredient and relevant guidance/SOPs.
Ability to evaluate the quality and effectiveness of the interactions between Office of Dietary Supplement Programs (ODSP) and internal organization partners.
Ability to characterize the subjects and various review approaches.
Experience in quantitative analysis and process standardization.
Internal Number: 9441
About Goldbelt C6
C6, a subsidiary of Goldbelt, Inc., is an urban, Alaska Native, for-profit corporation with locations in Juneau, Alaska and Herndon, VA. Its primary purpose is to manage assets and to conduct business for the benefit of its shareholders, approximately 3,600 people, almost all of Alaska Native heritage. Goldbelt C6 specializes in recruiting scientific subject matter expert's to support customer within the federal government to include the FDA and the CDC.