15 job(s) at FDA, CVM

FDA, CVM Rockville, MD
Mar 22, 2022
Full time
Summary This position is located in the Center for Veterinary Medicine/Office of New Animal Drug Evaluation which reviews information submitted by drug sponsors who desire to obtain approval to manufacture and market animal drugs.
FDA, CVM Rockville, MD
Mar 14, 2022
Full time
As a member of the Division, the Mathematical Statistician’s primary responsibility is to evaluate study protocols and review results from studies investigating the effectiveness and safety of animal therapeutic and production drugs or animal bioengineering and cellular therapies  products for indications in some of the following areas: antiparasitics, reproduction, weight control, appetite stimulation, thyroid disorders, diabetes, cardiovascular concerns (blood pressure, heart), ophthalmic, hematology, and renal/urinary disorders, immunosuppressants, control of pain, epilepsy, and for neurological, dermatological, otic,  muscular disorders.  You will also provide statistical consults for human food safety studies, toxicology studies, post-marketing studies, research projects, and other related work.  You will use statistical and mathematical methods to analyze and draw inferences from data submitted by animal drug applicants and to facilitate the Center scientists in study design development, appropriate data analysis, and data interpretation. Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions; therefore, we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment.  Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.   Education Requirements: A Ph.D. degree in Mathematics or Statistics, or a related field. For specific information on education requirements please visit the following links: Mathematical Statistician: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/1500/mathematical-statistics-series-1529/ Professional Experience Requirements: Applicants should have experience performing statistical analyses on biological or biomedical research problems, conducting reviews evaluating statistical methods, procedures, and concepts involved with biological or biomedical applications and advising or commenting on the adequacy of statistical research plans, protocols, methodologies, data analyses and interpretation of results. The positions are located in Rockville, Maryland and are available immediately. The positions will be filled through FDA’s Staff Fellowship program. Appointments will be made up for up to two years with opportunities for renewal. Applicants may be required to live in, or be willing to relocate to, the greater Washington DC area. The salary range is $74,950 to $138,868 based on experience and education. Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “ONADE Mathematical Statistician Staff Fellow Positions ­­­­­­–Hire Latinos.” Questions may also be directed to the CVM Opportunities mailbox. Applications will be accepted through April 13th, 2022. **Applications will be reviewed, and interviews will be scheduled on a first come, first serve basis. **
FDA, CVM
Dec 17, 2021
Full time
Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance (OS&C)     Position: Supervisory Regulatory Counsel     Pay Plan-Series: AD-0301   Location : Duty station negotiable after selection   Travel Requirements: <25%   Application Period: December 17, 2021 – January 7, 2022   Salary: Starting at $144,128 (Band E)   Area of Consideration: United States Citizens or Nationals   Relocation Expenses Reimbursement: Relocation expenses will not be paid.   Special Notes: This position is being filled under a streamlined 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 this authority. Additional information on 21st Century Cures Act can be found here: 21st Century Cures Act Information . Introduction The Food and Drug Administration (FDA or Agency) 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 Veterinary Medicine (CVM) is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, CVM evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.   The Office of Surveillance and Compliance (OS&C) has primary responsibility for: compliance-related actions, post-approval monitoring, and animal feed safety. OS&C monitors the safety and effectiveness of marketed drugs after they enter the market. Working with the U.S. Department of Agriculture and State agencies, the Office monitors the occurrence of unsafe drug residues in meat, milk, and poultry products. OS&C assures the safety of animal food by reviewing new animal food ingredients, providing oversight of the medicated feeds program, and providing oversight of the feed contaminants program. The Office coordinates enforcement actions against unapproved animal food and drugs that are on the market and that threaten public and animal health. The Office regulates the promotion and advertising of animal drugs to ensure that they are promoted in a truthful and non-misleading way, and each year receives more than 100,000 adverse drug events that are used to provide updated safety and effectiveness information to consumers.   To learn more about OS&C click here . Duties/Responsibilities As a Supervisory Regulatory Counsel you will:   Serve as an expert advisor to Office, Center, and Agency staff regarding the laws and regulations relating to pre-market surveillance and compliance activities of regulated animal products. Research and evaluate CVM’s and FDA’s regulatory needs to support and influence legislation and executive initiatives. Supervise the Regulatory Policy Team, overseeing the review and analysis of FDA policies governing Agency and CVM regulated animal products and pertinent surveillance and compliance actions. Conditions of Employment S. Citizenship requirement or proof of being a U.S. National must be met by closing date. This position is subject to the COVID-19 vaccine mandate as a condition of employment. In accordance with Executive Order 14043, Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee’s duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement. 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 Education Requirements: A juris doctorate degree from an accredited institution of higher learning. Professional Experience Requirements: Leading work groups, teams or staff who develop or execute guidance or regulations related to the post-approval of regulated products; Evaluating the content of new or modified legislation or regulations to provide regulatory or policy advice to senior level management and/or high-level officials; Providing oversight of the review legal actions, administrative enforcement actions or advisory actions for regulated products.   Additional Desired Experience: 3 years in an attorney or regulatory professional role providing advice on federal regulatory issues with regard to animal products. 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 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 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 Please submit your letter of interest, resume, and copy of transcripts by January 7, 2022 to: CVMOpportunities@fda.hhs.gov with the subject line of “Supervisory Regulatory Counsel – Hire Latinos—OSC.” Announcement Contact For questions regarding this announcement, please contact CVMOpportunities@fda.hhs.gov using the subject line provided above.        Safeguarding human and animal health is what we do. When you join our team, you impact this unique and amazing mission no matter your position. You also join a diverse community of exceptional people who encourage and support everyone to dream, inspire each other, and live our best lives, personally and professionally. When you join CVM, you join an incredible place to work.   The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.   FDA is an equal opportunity employer.  
FDA, CVM Duty station negotiable after selection
Dec 09, 2021
Part time
Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Office of the Director (OD)     Position: Regulatory Counsel     Pay Plan-Series: AD-0301   Location : Duty station negotiable after selection   Travel Requirements: <25%   Application Period: December 9, 2021 – January 6, 2022   Salary: Starting at $87,198 (Cures Band B/C)   Area of Consideration: United States Citizens or Nationals   Relocation Expenses Reimbursement: Relocation expenses will not be paid.   Special Notes: This position is being filled under a streamlined 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 this authority. Additional information on 21st Century Cures Act can be found here: 21st Century Cures Act Information . Introduction The Food and Drug Administration (FDA or Agency) 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 Veterinary Medicine (CVM) is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, CVM evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.   The Office of the Director (OD) has primary responsibility for establishing and coordinating the overall regulatory policy and scientific direction of the Center. OD is also responsible for the Center's Freedom of Information Act activities, stakeholder outreach and engagement, customer service through the Ombudsman, international relations, as well as information management operations involving website content and 508 Compliance requirements. In addition, the Office provides individual and team coaching services and internal organizational change advice in support of CVM's operation as a High Performance Organization. To learn more about OD click here . Duties/Responsibilities As a Regulatory Counsel on OD’s Freedom of Information Act (FOIA) Staff, you will:   Conduct legal analyses of CVM and Agency records to determine whether documents can be released in litigation or in response to third-party subpoenas. Prepare responses to information requests from stakeholders while ensuring compliance with established CVM/FDA regulations, policies, and procedures. Provide advice and guidance to senior management and stakeholders on information requests involving litigation disclosure. Conditions of Employment S. Citizenship requirement or proof of being a U.S. National must be met by closing date. This position is subject to the COVID-19 vaccine mandate as a condition of employment. In accordance with Executive Order 14043, Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee’s duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement. 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 Education Requirements: A juris doctorate degree from an accredited institution of higher learning. Professional Experience Requirements: §  Applying Exemption B4 (Trade Secrets / Confidential Commercial Information) in the review of proprietary information; §  Conducting legal analysis to prepare justifications for the withholding and/or redaction of documents or portions of documents during the litigation process, including preparation of Vaughn Indexes or Privileged Logs associated with FOIA; and §  Redacting information from documents that are exempt from disclosure per the Freedom of Information Act (FOIA).   Additional Desired Experience: 2 years in an attorney or regulatory professional role providing advice on federal regulatory issues. 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 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 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 Please submit your letter of interest, resume, and copy of transcripts by January 5, 2022 to: CVMOpportunities@fda.hhs.gov with the subject line of “Cures Regulatory Counsel –United Latinos Job Board– OD.” Announcement Contact For questions regarding this announcement, please contact CVMOpportunities@fda.hhs.gov using the subject line provided above.        Safeguarding human and animal health is what we do. When you join our team, you impact this unique and amazing mission no matter your position. You also join a diverse community of exceptional people who encourage and support everyone to dream, inspire each other, and live our best lives, personally and professionally. When you join CVM, you join an incredible place to work.   The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.   FDA is an equal opportunity employer.
FDA, CVM
Dec 01, 2021
Full time
Summary This position is located in the Center for Veterinary Medicine, Office of Research, Division of Animal and Food Microbiology. Become a part of the Department that touches the lives of every American. At the   Department of Health and Human Services (HHS)   you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The mission of the Center for Veterinary Medicine (CVM) is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, CVM evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the U.S. Food and Drug Administration (FDA), CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels. Duties Serves as an authoritative Microbiologist performing research activities. Plans, develops, and conducts research in molecular biology, genomics, and microbiology to address agency questions around foodborne bacterial pathogens. Collaborates with and advises others on antimicrobial resistance in foodborne bacterial pathogens and other microbiological issues related to animal food and products, laws, regulations, and/or policies. Evaluates data and information from a variety of sources to determine the safety of animal foods and products. Interprets applicable scientific literature and study results to draw conclusions and make recommendations. 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. THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES. See section titled Additional Information for more Conditions of Employment for this position. Qualifications The position of Research Microbiologist falls under the   0403   occupational series. To qualify for this position at grade   GS- 13, you must meet the following: Basic Requirements A. Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. -OR- B. Combination of education and experience: courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education. AND Minimum Qualifications Specialized Experience . 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. You must possess 1 year of specialized experience equivalent to the GS-12 in the Federal service that includes experience: conducting laboratory research in foodborne and/or veterinary pathogens; and assessing antimicrobial resistance in foodborne bacterial pathogens and animal food microbiology to assure the safety of animal foods. 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://my.usajobs.gov/Account/Login , select the   Application Status   link and then select the   M ore 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. Vaccination Mandate: In accordance with   Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement. Expanded/Maximum telework Posture: Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement within 30 calendar days of receiving notice to do so, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy. Education TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.   If you are using education completed in foreign colleges or universities, see the   Foreign Education   section below for additional requirements. 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 employee, you are not exempt from transcript requirements. Electronic Transcript Caution:   If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the   Application Manager Documentation   for tips on submitting your paper-based documents. FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information:   (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.   Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services   (NACES) Association of International Credentials Evaluators   (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the   U.S. Department of Education website for Foreign Education Evaluation
FDA, CVM Rockville, MD
Nov 16, 2021
Full time
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) is seeking qualified applicants for Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals to approve safe and effective animal drugs. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal. This position is located within the Clinical Pharmacology Team of the Division of Scientific Support, in the Office of New Animal Drug Evaluation (ONADE). The team functions as subject matter experts in the disciplines of pharmacokinetics and biopharmaceutics. Using data submitted from scientific investigations, technical reports, opinion statements, and related information, team members evaluate drug dose-exposure relationships, absolute bioavailability and comparative bioavailability of new chemical entities intended for use in companion and food-producing animal species. In particular, reviewer responsibilities also include the evaluation of proposed pre-approval and post-approval formulation changes on the rate and extent of drug absorption by examining comparative drug concentration- time profiles in the blood or other biological fluid and comparative in vitro dissolution data. Upon completing this analysis, recommendations are made for Agency action regarding New Animal Drug Applications and Investigational New Animal Drug submissions. To support these responsibilities, applicants should have experience in the evaluation of pharmacokinetic data, including study design, assay methodology and validation, and experience in examining comparative in vitro dissolution profiles. They should have experience using pharmacokinetic software tools such as WinNonLin, NONMEM, or WinBUGS and a demonstrated ability to develop written summaries of their evaluations. Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multidisciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization. The position is located in Rockville, Maryland, Open 11/17/2021-12/17/2021 and is available immediately. The salary range for the GS-12 equivalent level is from $86,335 to $112,240, and for the GS-13 equivalent level from $102,663 to $133,465 based on experience and education. Further information regarding qualification requirements can be found at the following link: http://www.opm.gov/policy-dataoversight/classification-qualifications/general-schedule-qualification-standards/0400/pharmacology-series-0405/. , Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “United Latino Job Bank” – Division of Scientific Support Staff Fellow Pharmacologist Position”. Questions may also be directed to the CVM Opportunities mailbox.
FDA, CVM Rockville, MD
Nov 05, 2021
Full time
Overview Accepting applications Open & closing dates   11/05/2021   to   11/09/2021 This job will close when we have received   75 applications   which may be sooner than the closing date.   Learn more Salary $72,750   - $113,362 per year Pay scale & grade GS 11 - 12   Help Location 1 vacancy in the following location: Rockville, MD Telework eligible Yes—as determined by the agency policy. Travel Required Not required Relocation expenses reimbursed No Appointment type Permanent Work schedule Full-time Service Competitive Promotion potential 12 Job family (Series) 0343 Management And Program Analysis Supervisory status No Security clearance Other Drug test No Position sensitivity and risk Non-sensitive (NS)/Low Risk Trust determination process Suitability/Fitness Announcement number FDA-CVM-22-11286314-DH-YM Control number 620901600 Duties Assist in developing recruitment packages as part of the hiring and staffing process. Conduct research on human resource laws, regulations, guidelines, procedures, and methods to support human capital programs. Provide strategic advice, guidance and consultation to leadership on human capital and human resource matters in order to advance the Center's accomplishment of its mission. Requirements Conditions of Employment Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise. 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. 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. 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. THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES. See section titled Next Steps for more Conditions of Employment for this position.
FDA, CVM Rockville, MD
Oct 29, 2021
Full time
Summary THIS POSITION IS SUBJECT TO THE COVID-19 VACCINE MANDATE AS A CONDITION OF EMPLOYMENT. This Direct-Hire position is in the Food and Drug Administration and is located in the Center of Veterinary Medicine (CVM) in Rockville, Maryland. Become a part of the Department that touches the lives of every American. At the   Department of Health and Human Services (HHS)   you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. Agency contact information Open & closing dates   10/29/2021   to   11/08/2021 This job will close when we have received   100 applications   which may be sooner than the closing date.   Learn more Salary $72,750   - $113,362 per year Pay scale & grade GS 11 - 12   Help Location 1 vacancy in the following location: Rockville, MD Telework eligible Yes—as determined by the agency policy. Travel Required Not required Relocation expenses reimbursed No Appointment type Permanent Work schedule Full-time Service Competitive Promotion potential 13 Job family (Series) 0701 Veterinary Medical Science Supervisory status No Security clearance Other Drug test No Position sensitivity and risk Moderate Risk (MR) Trust determination process Suitability/Fitness Announcement number FDA-CVM-21-11266387ST-DH Control number 619540400 Duties Applies veterinary knowledge and experience to the assessment of new or marketed animal drugs, foods, and devices to assure their safety and effectiveness. Assists with the analysis and interpretation of data to determine the safety and effectiveness of animal drugs, foods, and devices. Advises on veterinary medical issues related to animal drugs, foods, and devices, associated laws, regulations, and policies as well as on scientific research and industry developments in veterinary medicine, animal nutrition, and related fields. Requirements Conditions of Employment Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise. 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. 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. 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. THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES A probationary and/or trial period for initial Federal employment may 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. You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office. Qualifications Vaccination Mandate : In accordance with   Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement. Expanded/Maximum telework Posture: Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy. The position of Veterinary Medical Officer falls under the 0701 occupational series. To qualify for this position at grade GS - 11/12, you must meet the following: GS-11 and GS-12 Basic Requirements A. Degree: Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association Council on Education (AVMA). http://www.avma.org OR B. Graduates of foreign veterinary medical schools that are not accredited by the AVMA Council on Education must meet one of the following requirements: 1. Proof of certification of their final transcript by the Educational Commission for Foreign Veterinary Graduates (ECFVG). 2. Possession of a permanent, full, and unrestricted license to practice veterinary medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States that includes successful completion of the North American Veterinary Licensing Examination (NAVLE) or its predecessors, the National Board Examination (NBE) and the Clinical Competency Test (CCT). 3. Proof that the education obtained in a foreign veterinary medical program is equivalent to that gained in a veterinary medical program that is accredited by the American Veterinary Medical Association Council on Education. Under this provision, equivalency is established only if an AVMA-accredited veterinary medical school or college accepts the graduate's final transcript from the foreign veterinary medical school at full value for placement into an advanced degree, postgraduate educational program, or training program (e.g. residency or graduate program). Graduates of foreign veterinary medical programs must also provide proof of proficiency in the English language by successfully completing one of the nationally and internationally recognized examinations that incorporate assessments of reading, writing, listening, and speaking skills. Examples of examinations that assess mastery of the English language are shown below: 1. Test of English as a Foreign Language (TOEFL) - Minimum scores for the TOEFL are 560 for the paper-based version; 220 for the computer-based version; or overall score of 83 for the internet-based version (including 26 or higher in speaking, 26 or higher in listening, and 17 or higher in writing). For the computer-based and paper-based test versions, applicants must also complete the Test of Spoken English (TSE) and the Test of Written English (TWE). Minimum required scores are 55 for the TSE and 5.5 for the TWE; 2. Academic tests (listening, writing, and speaking) offered by the International English Language Testing System (IELTS). Applicants must achieve a minimum overall band score of 7.0, with at least 7.0 in speaking, 6.5 in listening, and 6.0 in writing: OR Canadian Academic English Language Assessment (CAEL). Applicants must achieve a minimum overall band score of 70, with at least 60 in speaking, 60 in listening, and 50 in writing. ADDITIONAL REQUIREMENTS: GS-12 Specialized Experience:   Applicants must possess one year of progressively responsible professional veterinary experience equivalent to the GS-11 grade level: 1. Applying laws, regulations, policies, and procedures related to veterinary medicine. AND 2. Reviewing scientific documents and data related to veterinary medicine. AND 3. Providing scientific or regulatory recommendations on veterinary laws, regulations, laboratory practices, or protocols. OR Education: Master's degree in an area of specialization, including but not limited to, animal science, avian medicine, food safety, infectious diseases, veterinary clinical sciences, pathobiology, biomedical sciences, veterinary anatomy, veterinary preventive medicine, comparative biological sciences, epidemiology, veterinary parasitology, molecular veterinary biosciences, public health, microbiology, pathology, immunology, laboratory animal medicine, toxicology, wildlife, zoological animal medicine, or sciences related to the work of a veterinary medical officer position. OR Residency/Post-Graduate Training Programs: Successful completion of two years of an internship, residency program, or fellowship training program in a discipline related to the position. All qualification requirements must be met by 11:59 pm (Eastern Time) on 11/08/2021. 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. You must continue to meet all requirements through the hiring process. You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office. 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://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. Your uploaded documents may take several hours to clear the virus scan process. 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 NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.   If you are using education completed in foreign colleges or universities, see the   Foreign Education   section below for additional requirements. 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 employee, you are not exempt from transcript requirements. Electronic Transcript Caution:   If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the   Application Manager Documentation   for tips on submitting your paper-based documents. FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information:   (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.   Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services   (NACES) Association of International Credentials Evaluators   (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the   U.S. Department of Education website for Foreign Education Evaluation
FDA, CVM Rockville, MD
Oct 26, 2021
Full time
Summary This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE) located in Rockville, Maryland. Become a part of the Department that touches the lives of every American. At the   Department of Health and Human Services (HHS)   you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. Join the Center for Veterinary Medicine (CVM) in the  protection of human and animal health . At CVM, we are responsible for regulating food, food additives, drugs, and devices for millions of pets and food-producing animals. As a high performance organization, we strive for leadership, innovation, and excellence across all operations, occupations, and grade levels.  Learn more   about why CVM is the best fit for your talents. Begin your career with CVM today. Responsibilities Determines the environmental impact of substances used in animal drugs, devices, and feed/food additives. Conducts reviews of environmental data and effects data for chemicals to be considered for approval under new animal drug applications, feed/food additives and other applications. Prepares environmental assessments, environmental impact statements and findings of no significant impacts. Travel Required Not required Supervisory status No Promotion Potential 13
FDA, CVM Rockville, MD
Oct 13, 2021
Full time
Summary This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE) located in Rockville, Maryland Responsibilities Applies Biology knowledge and experience to the assessment of regulated products to assure their safety and effectiveness. Evaluates data and information from a variety of sources to determine the safety and effectiveness of regulated products as well as anticipate ancillary problems and suggests appropriate courses of action. Collaborates with and advises others on biology issues related to regulated products, laws, regulations, and policies. Travel Required Not required Supervisory status No Promotion Potential 13
FDA, CVM Rockville, MD
Oct 13, 2021
Full time
Summary This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE) located in Rockville, Maryland. Responsibilities Applies chemistry knowledge and experience to the assessment of regulated products to assure their safety and effectiveness. Evaluates data and information from a variety of sources to determine the safety and effectiveness of regulated products as well as anticipates ancillary problems, and suggests appropriate courses of action. Collaborates with and advises others on chemistry issues related to regulated products, laws, regulations, and policies. Travel Required Not required Supervisory status No Promotion Potential 13
FDA, CVM Rockville, MD
Oct 04, 2021
Full time
  The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Generic Animal Drugs is seeking qualified applicants for Microbiologist and Chemist positions. The Division protects public and animal health by ensuring the availability of safe, effective, and affordable therapeutic options for stakeholders through an efficient, science-based approval process for generic new animal drugs.    As a member of this Division, you will have a significant impact on the development and approval of these FDA-regulated articles that may benefit and improve the practice of both veterinary and human medicine.  Specifically, you will provide microbiology or chemistry expertise and knowledge to the assessment of the quality of new or marketed animal regulated products to assure their safety and effectiveness. Collaborates with and advises others on microbiological or chemical issues related to animal drugs, foods, devices, laws, regulations, and policies as well as scientific research and industry developments in microbiology and related fields. You will evaluate data and information from a variety of sources to determine the acceptability of the chemistry, manufacturing, and controls information for new animal drugs. Additionally, you will provide advice and guidance to FDA staff and stakeholders such as government agencies, industry, academia, and the public in one or more scientific areas related to microbiology (e.g., bacteriology, parasitology, virology).   Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment.  Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.   Education Requirements: A Ph.D. in Microbiology, Chemistry, or a related field. For specific information on education requirements please visit the following links: Microbiology https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/microbiology-series-0403/ Chemistry: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/1300/chemistry-series-1320/   Professional Experience Requirements: Experience analyzing scientific documents, technical data, and opinions related to new and/or generic animal drug products is preferred. Candidates should demonstrate the knowledge of the principals and practices of microbiological and chemistry related methods and study designs to the review and analysis of scientific data. The ability to communicate effectively and manage competing priorities while working in a fast-paced, team environment is also required. The positions are located in Rockville, Maryland and are available immediately. The positions will be filled through FDA’s Staff Fellowship program. Appointments will be made up for up to two years with opportunities for renewal. Applicants are required to live in, or be willing to relocate to, the greater Washington DC area. The salary range is $72,750 to $134,798 based on experience and education.       Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “ONADE Chemist & Microbiologist Staff Fellow Positions—Hire Latinos.” Questions may also be directed to the CVM Opportunities mailbox. Applications will be accepted through November 3rd, 2021. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**    
FDA, CVM Rockville, Maryland
Sep 23, 2021
Full time
(OS&C), Division of Animal Feeds (DAF) is seeking qualified applicants for a Microbiologist position. Multiple selections may be made.   OS&C has primary responsibility for several areas related to public and animal health. The Office monitors the safety and effectiveness of marketed animal drugs after they enter the market. OS&C assures the safety of animal food by reviewing new animal food ingredients, providing oversight of the medicated feeds program, and providing oversight of the feed contaminants program. OS&C coordinates enforcement actions against unapproved animal food and drugs that are on the market and that threaten public and animal health. OS&C regulates the promotion and advertising of animal drugs to ensure that they are promoted in a truthful and non-misleading way, and each year receives more than 100,000 adverse drug events that are used to provide updated safety and effectiveness information to consumers. DAF monitors and establishes standards for feed contaminants, approves safe food additives, evaluates Generally Recognized as Safe (GRAS) notifications, manages the FDA’s medicated feed and pet food programs, and participates in the review of biotech plant notifications. DAF also provides scientific support and guidance on all animal feed matters to FDA and state regulatory officials.  As a member in this Division, you will contribute to the mission of monitoring animal food and food ingredients to assure their safety and utility in animal diets. More specifically, you will analyze and interpret scientific data regarding animal food/feed, food microbiology, and fermentation processes; identify applicable information regarding scientific and regulatory activities and policies that protect human and animal health; research complex new scientific information that supports the regulatory review of marketed animal food/feed; and serve as a source of guidance on issues related to animal food/feed. The review of food ingredients includes scientific evaluation of data and information on the manufacturing of the substance, intended use and effect, safety for the animal, and safety of human food derived from these animals, as applicable.  These evaluations are undertaken for ingredients used in diets for food animals and for pets. CVM is located in Rockville, Maryland and the position will be filled through FDA’s Staff Fellowship program.  The appointment is for up to two years with opportunities for renewal.  The salary range is from $69,581 to $128,920 based on experience and education.  Further information regarding qualification requirements can be found at the following links: Microbiologist : https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/microbiology-series-0403/ Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “Division of Animal Feeds Staff Fellow Position – Hire Latinos”. Questions may also be directed to the CVM Opportunities mailbox. Applications will be accepted through October 22nd, 2021.   **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
FDA, CVM
Jul 30, 2021
Full time
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support is seeking qualified job applicants for the position of Toxicologist or Biologist.  The Division of Scientific Support provides expertise, leadership, and coordination to all CVM offices regarding environmental impact, pharmacology, and biostatistical evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals.  This position will be filled through FDA’s Staff Fellowship program.  The appointment is for up to two years with opportunities for renewal.    As a Toxicologist or Biologist, you will work on the Environmental Team conducting scientific evaluations and regulatory reviews prepared to meet the requirements of the National Environmental Policy Act (NEPA). This includes review of environmental assessments, terrestrial and/or aquatic ecotoxicology studies (e.g., soil microorganisms, plants, earthworms, dung fauna, algae, aquatic invertebrates, fish), and other data (e.g., environmental fate, transport, and exposure data) submitted by applicants of new animal drugs, feed/food additive petitions, and other types of applications.  The Team applies knowledge of environmental toxicology and chemistry, standardized test methodology, risk assessment methods and applicable laws and regulations to evaluate the potential environmental impacts from the investigational use and approval of new animal drugs, feed/food additive petitions, and other types of applications.  You will perform environmental risk analyses and will provide expertise and recommendations in this area to the Environmental Team and applicants.  You will also prepare review documentation, environmental assessments, and findings of no significant impact to support CVM decisions regarding the impact of the substances on the environment.  Job applicants should have experience reviewing, evaluating, and/or conducting ecotoxicity studies, and analyzing and evaluating environmental data.  Job applicants should have experience with standardized and/or internationally harmonized test guidelines such as those issued by the Environmental Protection Agency (EPA) and Organization for Economic Cooperation and Development (OECD), hands-on experience in ecotoxicology, performing acute and chronic effects studies, and/or writing environmental study evaluations. Preference will be given to those with experience related to terrestrial ecotoxicity studies (e.g., plant, earthworm, microorganisms, and/or dung fauna). Although not required, it is desired that job applicants have experience in evaluating and preparing environmental risk assessments for drugs, pesticides, and/or other environmental contaminants.   ONADE offers many benefits and operates in a hoteling work environment.  Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required (when in person attendance is deemed important and regardless of need, no less than 2 days per pay period).  Applicants should be located in, or willing to relocate to, the greater Washington DC area.  ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization. The position is located in Rockville, Maryland and is available immediately. The position can be filled at the GS-12 or GS-13 equivalent level based on experience and education.  The salary range for the GS-12 equivalent level is $87,198 to $113,362 and for the GS-13 equivalent is $103,690 to $134,798.  Further qualification requirement information can be found at the following links: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/toxicology-series-0415/ https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/ The vacancy announcement will close 8/30/2021.  **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.** Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “Hire Latinos-EST Toxicologist”.  Questions may also be directed to the CVM Opportunities mailbox.  
FDA, CVM Rockville, Maryland
Apr 23, 2021
Full time
    The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of the Director (OD), is seeking qualified applicants for a Veterinary Medical Officer position. CVM’s mission is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, the Center evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.   OD has primary responsibility for establishing and coordinating the overall regulatory policy and scientific direction of the Center. OD is also responsible for the Center's Freedom of Information Act activities, stakeholder outreach and engagement, customer service through the Ombudsman, international relations, as well as information management operations involving website content and 508 Compliance requirements. In addition, the Office provides individual and team coaching services and internal organizational change advice in support of CVM's operation as a High Performance Organization.   As a Veterinary Medical Officer, you will have a significant impact on enhancing the Office’s COVID-19 response capabilities across the One Health arena. Specifically, you will: Manage and coordinate One Health activities between CVM and FDA as well as other government agencies and entities; Provide input into and coordinate One Health activities with the Center Director, and Deputy Center Director; Stay abreast of COVID-19-related and other zoonotic disease developments, both domestically and internationally, particularly from a One Health perspective; Network, exchange information, and raise awareness of the use and benefits of One Health principles, examples and practices; Advise on veterinary medical issues related to animal drugs, laws, regulations, and policies as well as scientific research and industry developments in veterinary medicine and related fields. It is desirable that applicants have a Master’s in Public Health in addition to their veterinary medical degree, and/or a combination of relevant education and experience. Experience in One Health Activities, including with COVID-19, is preferred. Candidates should demonstrate proficiency and an understanding of One Health and the inter-relationship of veterinary medicine, human medicine and environmental factors related to One Health. The ability to communicate effectively and manage competing priorities while working in a fast-paced, team environment is also required. The position is located in Rockville, Maryland and is available immediately. The position will be filled through FDA’s Staff Fellowship program. Appointments will be made up for up to two years with potential opportunities for renewal. The salary range is $87,198 to $134,798 based on experience and education. Further information regarding qualification requirements can be found by visiting the following link:     Veterinary Medical Officer https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0700/veterinary-medical-science-series-0701/ Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “OD COVID-19 Staff Fellow Position – HireLatinos.”  Questions may also be directed to the CVM Opportunities mailbox. Applications will be accepted through May 10, 2021. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**   Why CVM? Safeguarding human and animal health is what we do. When you join our team, you impact this unique and amazing mission no matter your position. You also join a diverse community of exceptional people who encourage and support everyone to dream, inspire each other, and live our best lives, personally and professionally. When you join CVM, you join an incredible place to work.