Writer-Editor

Summary

This position is located in the Center for Drug Evaluation and Research (CDER), Office of Manufacturing Quality (OMQ), Manufacturing Guidance Policy Staff (MGPS) located in Silver Spring, MD. which develop and implement compliance and enforcement policies and actions to protect patients from firms whose quality standards and practices may pose a significant risk to public health.

Learn more about this agency

Duties

• Performs initial reviews and studies a wide variety of documents government-wide; press, public, academic, and scientific and medical policy and program sources, in order to maintain a working and current knowledge of critical organizational issues.
• Writes and edits assignments related to the Food, Drug, and Cosmetic Act (the Act) and other regulatory authorities.
• Reviews, proofs, edits internal documents and warning letters and drafts internal documents, guidance, standard operating procedures, etc.
• Participates in meetings, conferences, and interviews, and collects data as appropriate to identify and discuss issues and problems to address assignments and activities.
• Conducts research on assigned subjects to identify and develop reliable information sources within and outside the FDA to obtain subject information that includes medical or scientific program, policy and research issues and educational materials.
• Drafts and edits medical alerts or informational postings.
• Develops, prepares, drafts and edits primary material in support of Office initiatives and program responsibilities.
  
  

Requirements

Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
  
  

Qualifications

The position of Writer-Editor falls under the 1082 occupational series. To qualify for this position at grade GS-12, you must meet all requirements by 11:59 pm EST on 01/14/2025.

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.

GS-12: You must have 1 year of specialized experience equivalent to at least the GS-11, in the Federal service, which includes: conveying information in a written medium to a variety of audiences and responding to the public and news media concerning to policy decisions or issues.

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. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system.

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.

Education

There is no education substitution for this position at the GS-12 grade 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 in positions with the FDA, the agency 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:

• the day the limit is reached,
  
  

-OR-

• the pre-defined closing date of 01/14/2025, 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, if applicable, for this advertisement is: 100

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

Financial Disclosure: Please be advised that this position may 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.

If you are serving, or have served in the last 5 years (from 01/14/2025) 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. https://www.opm.gov/frequently-asked-questions/political-appointees-and-career-civil-service-positions-faq/

• Incentives: 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.
• Pre-Employment Physical: No
• Drug Testing Requirement: No
• License Requirement: No
• Immunization Requirement: No
• Mobility Agreement Required: No
• Bargaining Unit: Yes - National Treasury Employees Union
  
  

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.

All requirements must be met by the closing date of this announcement (01/14/2025); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

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• Help
  
  

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. Opens in a new window Learn more about federal 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 You Will Be Evaluated

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

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

About Category Rating (DEU) Procedures (Basis For Rating)

• Category rating procedures will be used to rate and rank candidates.
• The answers you provide to the applicant self-assessment questions will be used, in conjunction with the supporting documents you include, and your resume, to determine your eligibility for Federal employment and your qualification for this position specifically.
• Your application score is used to place you into one of three quality categories: "Best Qualified", "Well Qualified", and "Qualified". (The category assignment is a measure of the degree in which your background matches the competencies required for this position.)
• The cut-off score for each quality category may vary from announcement to announcement, and is determined by each agency, in advance of the advertisement going live.
• Category Rating does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligible Vets who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10% or higher must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
• Interagency / Career Transition Assistance Program (I/CTAP):Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site .
  
  

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not need to respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.

• Manages and Organizes Information
• Planning and Evaluating
• Problem Solving
• Written Communication
  
  

To preview the application assessment questions, click the link below:

https://apply.usastaffing.gov/ViewQuestionnaire/12651384