Us Food And Drug Administration Work Values

Daily Duties at Us Food And Drug Administration :

TEAMWORK: Participate in reached methodologies to use in achieving work goals and objectives an in determining other management strategies. Oversaw development of technical data estimates, statistics, suggestions and other information useful to higher level managers in determining goals. Plans & Schedules ongoing productive-oriented work on quarterly and annual basis or directed assignments. Provided recommendations at not only at achieving assigned Program Goals, but assisted other supervisor at reaching theirs as well. Researched & development evidence to technical data for scientific methods; various validation processes and equipment for drugs, biologics, and devices; handled compliance information and recommendations in drug, device, and biologic cases. Successfully met and completed for biologics program area 12 month goal at 10 month expectation. SUPERVISORY/LEADERSHIP RESPONSIBILITY: General: Plans work accomplished by subordinates, sets and adjust short-term priorities and prepares schedules for completion of work. Assigns work based on subordinates priorities, selective consideration of difficulty and requirements of assignments and the capabilities of employees. Evaluates work performance of subordinates. Give advise, counsel or instruction to employees on both work and administrative matters. Identifies development & training needs of employees, providing for and arranging for needed development and training. Find ways to improve production or increase quality of work direction. Develop performance standards. Interviewed, heard, and resolved complaints from employees. Program Monitor: coordinated, reviewed, endorsed, provided improvement and compliance recommendations on work assignments for the two Biologics Specialist, Bioresearch Specialist, Drug Specialist and Drug Pre-Approval Specialist. Supervised 12 other employees that conducted work in Devices, Human and Veterinarian drugs, Biologics, Bioresearch monitoring, and Foods. Monitored their daily operations, provided input, endorsed their foreign and domestic established inspections and case work reports to ensure compliance recommendations met internally and externally. Mentored and Motivated three subordinates under my supervision to supervisory level promotion. Acted as Supervisory Level I Auditor for new hires using a Preferred Supervisory approach to evaluate general new hire current GMP training and Level I Certification in Devices, Drugs, and Biologics inspections. Supervised and demonstrated ability to handle resource needs compliance issues for two off-site resident post. NEGOTIATING/LIAISON/WRITTEN & ORAL COMMUNICATION: FDA Agency Headquarters (CVM/CDER/CBER/CDRH) administration support staff or with comparable personnel in other Federal agencies (CDC, USDA, EPA etc). Key staff of public interest groups, contracting officials and high level technical staff of large industrial firms, professional organizations and/or state & local government managers doing business with the agency (FDA). Purpose of the above to justify, defend, and/or negotiate with to obtain and communicate resources, to show and gain compliance with established policies, regulations or contracts. Contact at this level involve active participation in conferences, meetings, and hearings. Acted as liaison for investigators with the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation Research (CDER), Center for Device and Radiological Health (CDRH), Center Veterinary Medicine (CVM), personnel. Participated as a detached observer in a higher level Supervisory Succession Planning Focus Group for the FDA. Utilized mixed-method techniques to analyze diagnostic data to create customized surveys. Participated in communication, inspectional organization and managed inspectional work with Center for Drug Evaluation Research (CDER) in a pre-approval for a drug shortage prevention effort. Communicated with Center for Drug Evaluation and Research (CDER) and Pre-Approval Specialist on several submitted drug applications. Completed successfully a Center for Veterinarian Medicine (CVM) veterinarian labeling initiative and submission requirement with a regulatory compliance issue. Acted as liaison between center personnel, northeast district office, and midwest district office. Participated in several accelerated incident command handling major and minor incidents; recalls, drug shortages, complaints, in biologics, drugs, foods Monitored inventory and trending of Bioresearch Medical Devices to ensure quality and data integrity of submitted investigational and marketing of Device reports for the district and CDRH.

What they like about Us Food And Drug Administration :

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Leadership, Negotiating, Teamwork, Process analysis , Oral/Interpersonal Communication, Regulatory Compliance, Quality Assurance, Regulatory Affairs, Georgia, BA Chemistry, MA Management courses, Quality Systems, FDA/ICH Guidelines, Process Review, Process Reengineering, Process Improvement, Protocol Execution, Project Management, OD Change Management

Skills

Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Sales Support, Software Implementation, Leadership , Negotiating , Leadership , oral/written/interpersonal communication, FDA regulations and guidances, cGMP Trainer, Team Member and Leader

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