Shire Veteran Jobs

Summary This position is located within the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), and Office of Policy for Pharmaceutical Quality (OPPQ). The office is located in Silver Spring MD. Responsibilities Collaborates with the supervisor, senior management, and the lead project manager to identify, document, and coordinate projects and provide consultation on project requirements. Establishes aspects of project scope and criteria, schedules and milestones, budgets and responsibilities of the participating parties, assumptions and risks, contingencies, and performance measurement criteria. Maintains contact and working relationships within all elements of the Center with respect to current/future project activities. Develops and communicates science and risk-based policies and standards related to drug product quality, including application review and inspection. Requirements Conditions of Employment Qualifications The position of Project Manager falls under the 0301 occupational series. To qualify for this position at grade GS-12/13, you must meet Time-in-Grade requirements by 11:59 pm EST on 06/03/2024. Minimum Qualifications: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. Specialized Experience GS-12. You must have one year of specialized experience equivalent to at least the GS-11 level in the Federal Service to include the following: assisting with leading and/or managing all phases of assigned projects to include planning, developing requirements, scheduling, tracking, and reporting; and resolving issues or concerns during the life cycle of a project. Specialized Experience GS-13. You must have one year of specialized experience equivalent to at least the GS-12 level in the Federal Service to include the following: overseeing project flow and accountability for an office; tracking documents and projects through to completion; and facilitating communication with internal and external staff members and managers regarding projects, work products and project activities. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply! PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://secure.login.gov/ select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for details. All requirements must be met by the closing date of this announcement (06/03/2024 ); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process. Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system. Education This series does not have an education qualification requirement or substitution at the GS-12 and GS-13 level. Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest, FDA reserves the option of setting an application number limit. When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either: (A) the day the limit is reached, -OR- (B) the pre-defined closing date of 06/03/2024, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET. The application limit for this advertisement is: Not Applicable. For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/ ADDITIONAL CONDITIONS OF EMPLOYMENT THAT MAY BE REQUIRED Pre-employment physical: NO Drug testing: NO License: NO Mobility agreement: NO Immunization: NO Bargaining Unit: YES - 3591 Financial Disclosure: NO This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Special Appointing Authorities: If you are applying to this announcement based a special eligibility, such as those for people with disabilities, veterans (or military spouses), or displaced employees under a career transition program, please pay careful attention to the Required Documents section for details on application requirements for each eligibility path, to include supporting document requirements. If you are serving, or have served in the last 5 years (from 06/03/2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.