Website Food and Drug Administration
These positions are located in the Office of Pharmaceutical Quality Operations (OPQO),Division of Pharmaceutical Quality Programs (DPQP), Pharmaceutical Quality Programs Branch (PQPB). The incumbents serve as national experts and provide expert technical advice and assistance to ORA HQ, field offices, other federal agencies, state, local, foreign regulatory agencies and the regulated industry on issues related to pharmaceutical drugs.
- Serve as a National Expert in inspectional and investigative techniques with an intensive knowledge of current and emerging technologies.
- Lead teams of specialist and/or generalist consumer safety officers (CSOs/investigators) and analysts to accomplish highly complex projects or assignments.
- Advise field and ORA headquarters Investigations and Compliance management, FDA Center Compliance management and specialist in the development and management of the most complex, controversial and precedent-setting regulatory cases.
- Maintain contacts with cooperating federal, state, local and foreign regulatory agencies, trade and cooperative organizations, FDA Centers and industry to achieve and maintain a uniform approach to the resolution of problems.
- Participate in inter-Agency meetings or conferences as an authority in specialty areas and participate in meetings or conferences within the Agency to plan cooperative activities and devise concerted approaches to problems.
- Identify the need for drafts and provide technical advice, counsel, leadership and comment in the drafting of regulations that affect the domestic and import industries within the specialty area.
- Develop agency policy relating to domestic and import program.
- Identify national/international training needs for federal, state, local and foreign regulatory agencies, the pharmaceutical industry and consumers.
- Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
- FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
- Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
- Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
- Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
- Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
- You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
- Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
- Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
Company: Food and Drug Administration
Vacancy Type: Full Time
Job Functions: Healthcare
Job Location: Washington, DC, US
Application Deadline: N/A