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Who May Apply: Current FDA/CBER employees with career or career-conditional appointments in the competitive service; former FDA/CBER employees with reinstatement eligibility based on previous career or career-conditional appointments. YOU MUST SUBMIT YOUR SF-50
This position is located in the Office of Compliance and Biologics Quality, Division of Manufacturing & Product Quality, Application Review Branch. The functions of the Branch are described in the current FDA Staff Manual Guide.
Additional selections may be made from this announcement.
The incumbent will act as project manager on supplements and product correspondence chaired in the division. Performs initial assessment and processing supplements which includes a regulatory assessment and the assignment of proper category of submission, according to current regulations and guidance.
Completes assigned tasks in compliance with milestones and deadlines while meeting the supervisor's/customer's requirements without supervisory oversight. Collaborates and communicates (shares knowledge) with Application Review Branch members as a point of contact on committees within CBER by providing oral and/or written progress updates and final reports that meet the requirements as defined by the objectives.
Resolve unanticipated problems or issues independently or bring to the attention of appropriate person(s) for resolution. Keeps abreast of current developments, policies, and procedures, within area(s) of responsibility. Enters DATA completely and accurately into the appropriate database(s). Creates and maintains branch workload databases.
Drafts correspondence clear and present to the requestor or designee by required deadline. Facilitate communication with customers regarding request, work products, and services.