Biologist

Employer
USAJobs
Location
Silver Spring, Maryland
Posted
Sep 09, 2019
Closes
Sep 17, 2019
Function
Administrative
Hours
Full Time
Duties

Summary

This Direct-Hire position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories.
See the sections below for more details on the duties & qualifications for this position.
Note: Salary figures shown represent the "Rest of U.S." locality pay rate. Salaries may vary based on the actual location you are hired at. You can reference OPM's 2019 General Schedule (GS) Pay Tables site to see the current pay rates adjusted for each locality area.
Learn more about this agency

Responsibilities

  • Works closely with senior level reviewers in the review and evaluation of scientific data submitted to the FDA by medical device industry to determine safety and efficacy of routine and non-complex medical device products.
  • Serves as a consultant and advisor to scientific and technical personnel inside and outside the agency in a wide-ranging arena of scientific subject matters to include the field of medical devices and/or radiological product analysis and methods.
  • Conducts and participates in discussions with industrial scientists and management officials regarding the development and regulation of medical devices.
  • Writes and evaluates guidelines concerning the data required in submissions to the Agency for medical devices and their marketing.
  • Develops, modifies, and evaluates guidelines concerning data required in device actions submitted to the Agency for medical devices.


Travel Required

25% or less - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
13

Requirements

Conditions of Employment

  • This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
  • Citizenship Requirement: You must be a U.S. Citizen or U.S. National to be considered for this advertisement. Foreign nationals or legal permanent residents are not eligible for consideration.
  • Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
  • 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.
  • 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.
  • Research Positions may require evaluation of the scientific contributions, recognition, and professional standing of the researcher, and may be subject to peer review. A writing sample or publication portfolio may also be required.
  • If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
  • 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. Your application may be shown to multiple hiring offices.
  • You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
  • 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.


Qualifications

*The closing date of this vacancy changed from 10/18/19 to 9/20/19.

BASIC QUALIFICATIONS:
In order be eligible for the position of Biologist,
(GS-0401-11/12/13) , you must meet the following requirements...

In order to qualify as Biologist, GS-0401-11, you must meet the following:

A. Have a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.

- OR -

B. Have a combination of education and experience -- courses equivalent to a major in biological sciences, agriculture, natural resource management, chemistry or related disciplines appropriate to the position. (You must submit your transcript(s) that demonstrates this coursework at time of application submission).

- AND-

MINIMUM QUALIFICATIONS REQUIREMENTS:
C. GS-11: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-09) in the Federal service that includes but is not limited to: conducting studies and investigations concerning biological, chemical, and/or physical processes that affect biology resources; writing reports that provide recommendations for change or improvement; and analyze conventional issues.

OR

Have 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree.

GS-12: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-11) in the Federal service that includes but is not limited to: developing scientific experiments, conducting biological studies/investigations and following established experimental protocols or developing new experimental/ biologic protocols; interpreting scientific and regulatory directives to provide recommendations to other scientists; and preparing synopsis of data submitted for review.

GS-13: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-12) in the Federal service that includes but is not limited to: providing scientific expertise of review biological experimentation processes; serving as an expert to provide technical advice for complex, scientific tests, investigate environmental/ biological conditions and/or
protocols to develop new techniques; and analyzing scientific data to evaluate ecobiological/ biological conditions and preparing synopsis of data submitted for review; and interpreting scientific directives to provide recommendations to other scientists.

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.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply through this announcement. Candidates will be referred as Commissioned Corps personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 09/20/2019 . If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.

Education

Foreign Education
If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .

Additional information

Additional Conditions of Employment:
  • Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
  • 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.
  • Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
  • Pre-employment physical required: NO
  • Drug testing required: NO
  • License required: NO
  • Mobility agreement required: NO
  • Immunization required: NO
  • Bargaining Unit Position: YES, 3591
  • Relocation 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. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
  • 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. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc
  • Interview Process: Structured interviews: may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.
  • Scientific Research Positions: Research positions require an evaluation of the scientific contributions, recognition and professional standing of the researcher as they related to the position being filled.
  • Writing Samples & Portfolios: A writing sample or publication portfolio may be required.
  • Peer Review: Some scientific and research positions may be subject to peer review.
  • Selecting Service Registration: If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov .


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 09/20/2019), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.

This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. We will evaluate you against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Additional Information:
  • If you are serving, or have served in the last 5 years (from 09/20/2019) 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. See Political Appointee FAQ - OPM for more..
  • 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 Help Desk (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. See the Reasonable Accommodation Policy for more information...
  • 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 See the EEO Policy for more information...


Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Credentialing

Required Documents

  • Resume

A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.

  • Cover Letter
  • DD-214/ Statement of Service
  • Disability Letter (Schedule A)
  • Disability Letter (VA)
  • License
  • Other supporting documentation not listed above
  • PCS Orders
  • Performance Appraisal
  • Professional Certification
  • Resume
  • Separation Notice (RIF)
  • SF-15
  • SF-50/ Notification of Personnel Action
  • Transcript

These documents may be required for some applicants . Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorial video on the USAJOBS YouTube channel , or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

Learn more about supporting documents and documentation requirements on USAJOBS:
  • How to Understand the Required Documents Section
  • What Types of Documents May I Need?
  • How to Manage Your Documents on USAJOBS


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.

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