Food and Drug Administration Associate Director for Management (Executive Officer) in Silver Spring, Maryland

  • Duties

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Duties
Summary

This position is located in the FDA, Center for Biologics Evaluation and Research in Silver Spring, MD.

The Food and Drug Administration is the regulatory, scientific, public health and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that radiation emitting devices are safe; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals are safe; and for tobacco product regulation in order to decrease the tremendous toll of disease, disability, and death caused by tobacco use in the United States. FDA's programs are national in scope and effect, and the agency's activities have a direct and significant impact on multi-billion dollar industries, in addition to protecting the health and safety of American consumers.

The Center for Biologics and Research (CBER) is responsible for the regulation of complex biologic products including blood products, vaccines, allergenic products, and cell, tissue, and gene therapies. The CBER Office of Management (OM) leads procedural and process changes through developing and applying new strategies to emerging problems and new management initiatives, allocating dollars and staff resources to CBER's program offices, monitoring their usage, and setting priorities to improve the level of customer service and program performance to meet CBER's goal of protecting and promoting the public health. OM directs and monitors human resources, budget, payroll, space issues, assistance on human resources, provides administrative and technical support for advisory committee meetings, as well as provides laboratory and equipment support. In supporting the mission of the agency, OM develops, maintains, and supports a high quality and diverse work force.

This position is in the Senior Executive Service (SES), an elite group of senior government leaders who possess a diverse portfolio of experience and expertise required to lead across organizations. This cadre of dedicated executives is charged with providing strategic leadership and upholding a commitment to public service that transcends loyalty to a specific agency mission or individual profession. As an SES member, you will influence the direction of innovation and transformation of the Federal Government and lead the next generation of public servants.

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Responsibilities
  • Collaborates with other senior officials across the Department in the development and implementation of strategic and financial plans;
  • Ensures efficient and effective administrative operations, resolves major problem and matters of key policy, promotes and leads major reviews and discussions regarding improvements in administrative and management operations and processes;
  • Through regular and special meetings, correspondence, and other means, executive ensures that information or developments in the administrative and management areas are communicated to appropriate staff in CBER or throughout the FDA;
  • Oversees the development of plans and reviews relating to continuous improvements initiatives and ensures that effective systems are developed and in place to provide CBER, FDA and Departmental officials with information needed;
  • Represents CBER in matters of agency operations and management to Congress, HHS organizations, other health agencies, and other Federal agencies; acts on behalf of the CBER and FDA, including the exercise of delegated authorities;
  • Resolves problems concerning organization and administration in their assigned area; acts to improve organizational structure, management policies, and techniques;
  • Keeps the total management process in mind to develop solutions to emerging problems in management of a critical and/or controversial nature which may impact successful implementation of CBER programs;
  • Directs management activities, Departmental initiatives, and is instrumental in transforming administrative activities from processes to strategically focused business lines that support the Department's mission;
  • As a member of the FDA executive team, leads implementation of strategic human resources management, competitive sourcing, integration of budget and performance goals, and improved financial performance within the FDA;
  • Integrates administrative activities to achieve breakthrough efficiencies, coaching and motivating staff professionals to excel in creating positive solutions to improve service delivery;
  • Works with peers throughout the Department;
  • While a primary focus of the executive is management and administrative operations, his/her expertise, advice and counsel are also sought for all programs and their impact on the strategic plan and objectives of the Centers;
  • Serves as a catalyst and agent for the Center Director, accompanying or representing him/her at meetings and, in general, serving as the Center's focal point with delegated authority to negotiate and resolve policy issues;
  • As a senior administrative/management official within the FDA, executive provides leadership for and/or oversees the conduct of administrative operations;
  • Administrative operations include: program planning and evaluation, procurement, contracts management, budget formulation and execution, human capital, strategic human resources management, space and logistics, travel and risk management;
  • Participates with Center and FDA leadership in providing operational and management expertise germane to the formulation of policies, goals, objectives, and operational strategies;
  • Participates in program and resource allocation decisions which impact the total organization;
  • Serves as the CBER's principal advisor to CBER senior management/senior FDA officials on agency operations and administrative management matters;
  • Acts as principal advisor on management tenets, techniques, and policies; requirements of administrative law and regulations; and methods and procedures.
Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status

Yes

Promotion Potential

00

  • #### Job family (Series)

0341 Administrative Officer

  • Requirements

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Requirements
Conditions of Employment
  • U.S. Citizenship is required for federal employment.
  • Background and/or Security Investigation is required.
  • Must complete 1 year SES probationary period, if not previously completed.
  • Application package must be received by closing date of this Announcement.
  • Ethics pre-clearance is required.
Qualifications

In order to qualify for Associate Director for Management (Executive Officer), 0341, ES - 00, you must process the following:

Specialized Experience Requirement To be qualified for this position, your résumé must reflect experience in a managerial capacity with responsibility for providing supervisory direction to a large and diverse organization responsible for promoting economy, efficiency, and effectiveness in the administration of programs and operations and preventing and detecting fraud and abuse in such programs and operations. This experience must be evidenced by sophisticated analytical skills, superior written and oral communication skills, good judgment, and experience in interacting with government and non-government officials. Typically, experience of this nature is gained at or above the GS-15 grade level in the Federal service, or its equivalent with state or local government, the private sector, or nongovernmental organizations. At this level, you would have typically been responsible for planning, directing, and evaluating work that included managing and/or supervising other managers. You must demonstrate in your résumé, significant achievements, increasing levels of responsibility as a manager, and a solid record of successful professional performance.

As a basic requirement for entry into the Senior Executive Service (SES), your* résumé* must show evidence of progressively responsible leadership experience that is indicative of senior executive level management capability, and that is directly related to the skills and abilities outlined under the Technical Qualifications (TQs), Desired Qualifications (DQs) and the five Executive Core Qualifications (ECQs) listed below.

Technical Qualifications (TQs) -- Your résumé must show that you possess the following TQs: 1. Senior level experience in analyzing, directing, and evaluating administrative and management operations, and formulating, executing and developing financial and management plans to achieve an organization's programmatic goals. 2. Demonstrated ability to work effectively across organizational lines in team leadership and matrix management contexts and to build strong working relationships among people and organizations with diverse interests and/or opinions. 3. Superior communication skills.

Desirable Qualifications (DQs)-It is desired that you have the following(please show in résuméif you possess these qualifications): 1. A graduate degree in a discipline related to this position. 2. Knowledge of the Department's Health and Human Services, Food and Drug Administration program, their interrelationships, and the social, political, economic and public health forces that affect them. 3. Demonstrable experience and ability to work on high profile, controversial and rapidly changing issues and programs in an environment that is highly visible and transparent (i.e. constant Congressional, scientific, media attention and with a high level of Agency, Department and White House oversight).

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at http://www.opm.gov/ses/references/GuidetoSESQuals2010.pdf. Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

Executive Core Qualifications (ECQs) -- Your résumé must show that you possess the following ECQs:

Fundamental Competencies are the foundation for success in each of the ECQs and should be evident over the course of your résumé: Interpersonal Skills; Oral Communication; Integrity/Honesty; Written Communication; Continual Learning; and Public Service Motivation. It is STRONGLY recommended that you visit the following Office of Personnel Management (OPM) webpage for more information regarding the Fundamental Competencies and ECQs. https://www.opm.gov/policy-data-oversight/senior-executive-service/executive-core-qualifications/.

  1. Leading Change: The ability to bring about strategic change, both within and outside the organization, to meet organizational goals. Inherent to this ECQ is the ability to establish an organizational vision and to implement it in a continuously changing environment. (Competencies: creativity and innovation, external awareness, flexibility, resilience, strategic thinking, vision)

  2. Leading People: The ability to lead people toward meeting the organization's vision, mission, and goals. Inherent to this ECQ is the ability to provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. (Competencies: conflict management, leveraging diversity, developing others, team building)

  3. Results Driven: The ability to meet organizational goals and customer expectations. Inherent to this ECQ is the ability to make decisions that produce high quality results by applying technical knowledge, analyzing problems, and calculating risks. (Competencies: accountability, customer service, decisiveness, entrepreneurship, problem solving, technical credibility)

  4. Business Acumen: The ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)

  5. Building Coalitions: The ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals. (Competencies: partnering, political savvy, influencing/negotiating)

The application process for this position is RESUME ONLY. You should address the TQs, DQs, and ECQs within the context of a 5-page résumé. Any information submitted in excess of 5 pages WILL NOT be considered. We strongly encourage you to submit a résumé that is tailored specifically for this position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed (e.g., budget, type/# of staff supervised) and program accomplishments, including the results of your actions.

If selected, you will be required to complete an ECQ package by drafting narratives for each of the ECQs for submission and certification by an OPM Qualifications Review Board (QRB) in order to be placed in this position. If you are currently serving in a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed an SES Candidate Development Program approved by the Office of Personnel Management (OPM), you will not need to draft the ECQs.

Education

There is no education required for this series.

Additional information
  • If you are serving, or have served in the last 5 years (from 06/18/2018) 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, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
  • Probationary Period: Persons newly selected for career appointment to the SES must have their ECQs approved by the OPM Qualifications Review Board and will be required to serve a one-year probationary period.
  • Relocation:Travel, transportation, and relocation expenses may be authorized subject to funds availability and the agency's determination that it would be in the best interest of the Government to authorize such payments as allowed by regulation. A relocation incentive is not authorized.
  • Mobility: Individuals selected for SES positions may be subject to reassignment across geographic, organizational, and functional lines.
  • Direct Deposit: All Federal employees are required to have Federal salary payments made by electronic direct deposit to a financial institution of their choosing.
  • Selective Service: As a condition of employment, all male applicants born after 12/31/1959, must have registered for the selective service. If selected for this position, the applicant must sign a statement certifying his registration, or the applicant must demonstrate exempt status under the Selective Service Law.
  • Veterans' Preference: does not apply to the SES.
  • Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center HelpDesk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
  • Equal Employment Opportunity: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
  • E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.

Benefits for federal employees: https://www.usajobs.gov/Help/working-in-government/benefits/

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How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 06/18/2018).

Your résumé and responses to the Assessment Questionnaire are an integral part of the process for determining your basic and specialized qualifications for the position. Responses that are not supported by your résumé will eliminate you from consideration. Your application will be evaluated in the following manner.

  1. Application packages will be reviewed for completeness. Incomplete or late packages will not receive further consideration.

  2. Basic qualifications review. Your résumé and questionnaire will be reviewed to ensure that you meet the Specialized Experience Requirement. If you do not meet this requirement, you will not receive further consideration.

  3. If it is determined that you meet the basic qualifications for the position, your application package will be further evaluated by a rating and ranking panel, and highly qualified candidates may be invited to participate in a structured interview, submit writing samples, and undergo reference checks. Top candidates may be required to submit further written documentation of qualifications.

  4. The HHS FDA Executive Resources Board will review results and make recommendations on final selections to the appointing authority.

All information concerning qualifications is subject to investigation. You should expect that we will verify performance, suitability, security information and take that information into account in making employment offers. False representation may be grounds for non-consideration, non-selection, and/or appropriate disciplinary action. All initial appointments to an SES position are contingent on approval from OPM's Qualifications Review Board unless the selectee has successfully participated in an OPM approved SES Candidate Development Program. An individual's initial SES career appointment becomes final only after the individual successfully completes a 1-year probationary period. For additional information concerning the SES visit http://www.usajobs.gov/SeniorExecutives.

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Background checks and security clearance
Security clearance

Public Trust - Background Investigation

  • Required Documents

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Required Documents

You are encouraged to apply online. Applying online will allow you to review and track the status of your application.

All applicants are required to submit the following supporting document type(s):

  • Resume
  • SF-50 Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
  • Cover Letter
  • Other (QRB Certification, if applicable)

We strongly encourage you to submit a résumé that is tailored specifically for this executive position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed and program accomplishments, including the results of your actions. Applicants typically provide the following information in their résumé: * Vacancy announcement number and title of position - * Full name, mailing and email addresses, day and evening telephone numbers. * Educational information, including the name, city and state of colleges or universities attended, as well as the type of degree received. * Information about paid and unpaid work experience related to the position, including: title, duties and accomplishments, employers' name and address, duration of employment, and salary (or Grade, if Federal). * Information about honors, awards, and special accomplishments.

Financial Disclosure Reporting:The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a Public Financial Disclosure Report (OGE form 278) prior to assuming the SES position, annually, and upon termination of employment. Visit the Office of Government Ethics website at www.oge.gov and select Financial Disclosure. Frequently Asked Questions can be found at FAQs/. https://www.oge.gov/web/oge.nsf/Public%20Financial%20Disclosure.

Do NOT include Personally Identifiable Information (PII) such as Social Security Number or Date of Birth on your résumé. For other Résumé and Application tips, visit https://help.usajobs.gov/index.php/MostEffectiveResumes.

For Most Effective Resumes Tips visit: https://help.usajobs.gov/index.php/MostEffectiveResumes

Please visit the YouTube Link for additional Tips: https://www.youtube.com/watch?v=bqYkibnuiJU

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

  • Benefits

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Benefits

A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.

Review our benefits

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.

  • How to Apply

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How to Apply

To apply for this position, you must provide a complete Application Package, which includes all of the documents listed in the REQUIRED DOCUMENTSsection of this vacancy announcement.

The application method for this position is "Résumé Only."Your résumé must not exceed five (5) pages, including an optional cover letter. Any information in excess of 5 pages will not be evaluated. Any documents submitted that are not listed in the Required Documents section of this announcement will not be considered.

A complete application package for this vacancy must be received on-line via the USA Staffing web site by 11:59 PM (EST) on the closing date to receive consideration. Mailed/emailed applications will not be accepted.

  • To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

  • Click the Submit My Answers button to submit your application package. 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://my.usajobs.gov/Account/Login), 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. Note: Your uploaded documents may take several hours to clear the virus scan process.

  • To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your résumé and/or other documents from your USAJOBS account or your application will be incomplete.

Note: To return to a previously Saved or Incomplete application you may use the following link: https://applicationmanager.gov.

If you are unable to apply online and have the required information, please call 1-478-744-2360 to start your Alternate Application. You will be connected with a member of our staff who will initiate the Alternate Application process. More information on the Alternate Application process can be viewed at the following link: https://help.usastaffing.gov/Apply/index.php?title=AlternateApplicationInformation.

Questions regarding this vacancy or the application process should be directed to the HR Specialist. The HR Specialist, Shawniece Beale can be reached at 240-402-4394. Someone is available to answer phone calls and emails from 9:00 AM through 5:00 PM Eastern Time, Monday through Friday excluding Federal holidays.

This position is located in the HHS Food and Drug Administration (FDA).

Visit our careers page Learn more about what it's like to work at Food and Drug Administration, what the agency does, and about the types of careers this agency offers. https://www.fda.gov/AboutFDA/WorkingatFDA/default.htm

Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.

You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed.

You are encouraged to apply online. Applying online will allow you to review and track the status of your application. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the ERIC Call Center HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email eric@fda.hhs.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10205516.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.

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Agency contact information
Shawniece Beale
Phone

240-402-4394

Email

Shawniece.Beale@fda.hhs.gov

Address

Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US

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Next steps

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (06/18/2018). You will receive application status updates via email and via USAJOBS as the process progresses.

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  • Fair & Transparent
Fair & Transparent

The Federal hiring process is setup to be fair and transparent. Please read the following guidance.

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

  • Equal Employment Opportunity (EEO) for federal employees & job applicants

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Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.

Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:

  • An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
  • An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
  • An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

Learn more about disability employment and reasonable accommodations or how to contact an agency.

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Legal and regulatory guidance
  • Financial suitability
  • Social security number request
  • Privacy Act
  • Signature and false statements
  • Selective Service
  • New employee probationary period

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/499867400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

Open & closing dates: 05/17/2018 to 06/18/2018

Salary: $126,148 to $189,600 per year

Pay scale & grade: ES 00

Work schedule: Full-Time

Appointment type: Permanent