General Health Scientist
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy announcement here: https://www.fda.gov/media/162895/download
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Generic Drugs (OGD) and its sub offices are to ensure high-quality, affordable generic drugs are available to the American public. OGD is the world leader in the science and regulation of generic drugs serving an essential role in advancing FDA’s public health mission.
The Office of Safety and Clinical Evaluation (OSCE) supports the timely assessment of ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act on equivalence standards for generics drugs with attention to coordinating complex scientific considerations. OSCE also supports the development and implementation of safety programs specific to a risk evaluation and mitigation strategy, required under the 2007 FDA Amendments Act, during the generic drug application review.
Duties/Responsibilities
As a General Health Scientist, the incumbent is responsible for the evaluation of the safety, efficacy, and/or substitutability of generic drugs consumed by the American people. Researches appropriate precedents, databases, and reference material in depth to gather, review, and evaluate existing regulations and guidance and new information about specific drug products or drug classes.
- Provides technical guidance on challenging regulatory and compliance issues in the pharmacy field to the public, government entities, academia, the media, industry representatives, and within the organization.
- As appropriate, reviews ANDAs for generic drugs and other types of submissions to support generic drug development and drug lifecycle issues that may relate to safety, efficacy, and substitutability of drug products.
- Develops valid scientific approaches and makes scientific decisions regarding the development of standards of excellence based on personal regulatory expertise.
- Compiles data to prepare briefings, presentations, and technical or scientific reports that convey relevant scientific data or clinical information to inform regulatory recommendations and brief Division, Office, and/or OGD leadership.
- Develop premarket primary safety reviews of clinical information to assess safety risks related to expedited safety reporting (e.g., serious adverse event report submissions from IND-exempt bioequivalence/bioavailability studies supporting ANDAs per 21 CFR 320.31(d)(3)).
Supervisory Responsibilities: N/A
Conditions of Employment
- U.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.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
- Qualified and Outstanding Candidates
- 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.
- 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 Requirement:
General Medical and Healthcare Series, AD-0601
Degree: Bachelor’s or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. For more information, please see: OPM Occupational Series Qualification Requirements.
Professional Experience:
Our ideal candidate will possess:
- Experience applying analytical, investigative, qualitative, and quantitative techniques and methods required to conduct analysis of pharmacology and regulatory problems and issues.
- Experience with drug product characteristics such as dosage forms.
- Knowledge and experience with applicable Federal laws and regulations regarding prescription and non-prescription drug product submissions or distribution.
- Experience utilizing written and oral communication techniques to prepare and deliver reports and presentations.
- Demonstrated ability to select, interpret, and apply relevant guidelines to determine appropriate course of action.
- Ability to apply knowledge of scientific areas important to addressing premarket and post marketing drug safety and human factor review issues.
- Expert ability to communicate and work with staff at all levels of the organization and varying levels of domain expertise; demonstrated ability to collaborate across boundaries to build strategic relationships and achieve common goals.
- Ability to organize time effectively, determine priorities, and move work forward.
How to Apply
Submit resume or curriculum vitae with cover letter as a single PDF file by December 9, 2022, to: OGDHiring@fda.hhs.gov. Candidate resumes may be shared with hiring official 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 OGDHiring@fda.hhs.gov.
Announcement Contact
For questions regarding this Cures position, please contact OGDHiring@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.