The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.  The Office of Policy for Pharmaceutical Quality (OPPQ) develops, implements, and updates science and risk-based policies and standards related to human drug product quality, including application assessment and inspection.

OPPQ is looking for a Science Policy Analyst, who possesses a scientific background, and will be responsible for providing advice and consultation on drug quality program policy matters and provides analysis and recommendations for the effective development of policy and program strategies in the assessment of quality information submitted in drug applications.

Our ideal candidate will possess:

• Knowledge of regulatory policies, and procedures, related to the regulation of pharmaceutical quality is desired.
• Ability to identify and analyze problems; weight the relevance and accuracy of information; generate and evaluate alternative solutions; and make recommendations.
• Ability to communicate and work with staff across the organization and with differing expertise; demonstrated ability to collaborate across boundaries to work toward common goals.
• Ability to work independently and as a contributing, collaborative team member.
• Ability to organize time effectively, determine priorities, and move work forward.

Education Requirement:

General Physical Sciences, 1301: 

Degree:  physical science, engineering, or mathematics that included 24 semester hours in physical science and/or related engineering science such as mechanics, dynamics, properties of materials, and electronics.

Or

Combination of education and experience with education equivalent to one of the majors previously listed that included at least 24 semester hours in physical science and/or related engineering science, plus appropriate experience, or additional education.

General Natural Resources Management and Biological Sciences, 401: 

Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. 

Or

Combination of education and experience with courses equivalent to a major previously listed plus appropriate experience or additional education.

For more information please see: OPM Occupational Series Qualification Requirements

Conditions of Employment

• S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• 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.
• 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.
• Males born after December 31, 1959 must be registered with the Selective Service.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. 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.
• THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES. See section titled Vaccination Requirements for more Conditions of Employment for this position.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
   1. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
   2. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.

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.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Non-Sensitive/High Risk

A background security investigation will be required for all appointees.  Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet the requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security investigation or supplemental investigation may be required later.

Applicants are also advised that all information concerning qualification is subject to investigation.  False representation may be grounds for non-selection and/or appropriate disciplinary action.

Vaccination Requirements

To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a Federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.

Ethics Clearance Requirements

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.

Equal Employment Opportunity

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

Reasonable Accommodation

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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply

All qualified candidates should submit their resume with cover letter and unofficial transcripts (if you have foreign transcripts please submit a course-by-course foreign evaluation from an accredited company (NACES or AICE) by July 7, 2022 to: OPQOPPQRecruitment@fda.hhs.gov.  Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy.  Candidates can opt out of this process by annotating resume with “do not share”.  For questions, please contact OPQOPPQRecruitment@fda.hhs.gov.  Please reference Job Reference ID:  OPPQ Science Policy Analyst.