Jobs at CDER Frequently Asked Questions
Consumer Safety Officer Position
Chemical Engineering
Pharmacists
Regulatory Counsel
Medical Officers
Interdisciplinary Scientist
PHS Commissioned Corps
Internships/Pathways Program
Skill Sets
Loan Repayment Program
Staff Fellows
Recent Graduates
Location
Vacancy Announcements/Job Posting
Human Resources
Telecommute/Alternative Work Schedules
What to expect from FDA
Other hiring events
Consumer Safety Officer Position
Q: How much of the CSO position (%) is policy writing and development?
A: It depends on the Office and the subject matter that the CSO is assigned to.
Q: Are there differences in responsibilities for those CSOs working at a District Office vs a Resident Post? If so, what are they?
A: These positions are headquarters based.
Q: Can Microbiologist apply to the Consumer Safety Officer positions?
A: Yes, you can apply.
Q: Do you anticipate vacancy announcements for CSO positions at the GS-5/7/9 level or pathway programs for recent graduates in the near future?
A: Yes - please continue to watch USAJobs and the http://www.fda.gov/GDUFAHIRING/
Q: Are all CSO open positions located in the DC area?
A: All CSO positions in CDER are in the DC metro area. ORA CSO positions are open both in the DC metro area and in the district/field offices.
Q: When will Project Manager Positions open?
A: Project manager positions are often announced as "Consumer Safety Officer" positions.
Q: What types of positions are there for Registered nurses? I never heard too much information regarding nursing backgrounds?
A: Many nurses apply to positions for Consumer Safety Officers.
Q: Is a CSO an inspector? Do CSOs inspect domestically only? Or also internationally?
A: A CSO in CDER/OC can conduct inspections, both domestically and internationally, but generally, CSO are mostly focused on reviewing the inspection outcomes conducted by the Office of Regulatory Affairs (ORA)
Q: What is the difference between the CSO and CSO-ORA posting listed on the GDUFA site?
A: Click on each one and a description is given. The positions can be found by going to www.fda.gov/GDUFAHIRING
Q: Which of your sub-offices have a greater need for pharmacists?
A: The Offices of Unapproved Drugs and Labeling Compliance and Office of Drug Security, Integrity and Recalls typically hire pharmacists, and the Offices of Manufacturing and Product Quality and Scientific Investigations may also have a need for pharmacists.
Q: How many CSO positions will be filled by OC?
A: We will be hiring many CSO positions in 2013 and 2014.
Q: I do not see Project Managers listed on the GDUFA website, how does one apply for one of these positions.
A: may apply to the CSO positions that are currently open as many of our project managers are hired as Consumer Safety Officers. There will also be Project Management Officer Positions that will be opening later in the year - please continue to check the GDUFA website for new and new upcoming announcements.
Q: Are there any nurse coordinator positions available?
A: Many nurses apply for consumer safety officer positions which have a science background requirement.
Q: Will OC have CSO conducting inspections in the field?
A: Yes
Q: What is the minimum educational requirement for a Consumer Safety Officer? Bachelor or Master Degree in the health/life sciences?
A: CSO Education Requirement: Degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. You will need to submit transcripts with your applications.
Chemical Engineering
Q: Who would be the best to contact regarding Chemical Engineering positions in the DC area?
A: There is no individual contact for the Chemical Engineering announcement. Various offices across the Center for Drug Evaluation and Research, including the Office of Compliance, are looking to hire Chemical Engineers. Please refer to the non-government employee announcement on USA Jobs, which closes July 31: https://www.usajobs.gov/GetJob/PrintPreview/338738500
Q: The job post for a Chemical Engineer is past. Is the Office of Compliance still hiring for that position?
A: FDA/CDER will continue to post positions through Fiscal Year 2015
Pharmacists
Q: What type of experience, as a pharmacist, would be helpful?
A: Effective writing and oral communication skills, as well as skills obtained from practicing pharmacy such as the clinical use of drugs, understanding the potential cause and impact of adverse events, and skills communicating with other health care professionals.
Q: Is there a minimum level of experience that you require for pharmacists?
A: For the direct hire pharmacist, you must possess 1 year of experience
Q: Which sub-office of OC would be a good fit for a Pharmacist with an interest in epidemiology / surveillance?
A: OMPQ
Q: Is there an opportunity for pharmacists with clinical skills only who worked in outpatient and inpatient facilities?
A: Absolutely! Please apply to the Direct Hire Pharmacists and/or Pharmacologist positions. Go to www.fda.gov/GDUFAHIRING to see positions specific to this event. Also, FDA advertises all positions via OPM's USAJobs.gov
Q: For the pharmacist jobs, USAJobs lists the 6th cutoff as 6/27/13. Is the process closed for pharmacists?
A: As the FDA has direct hire authority for pharmacists, we are always accepting pharmacist applications. Please feel free to submit to CDEROC_recruit@fda.hhs.gov. Eventually a new application link will be available for pharmacists as well on USAJobs.
Q: How many international trips will be required with the CSO positions?
A: Travel is based upon the need of the office and the agency. Most travel is to conduct inspections and most inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).
Regulatory Counsel
Q: Are there openings for Nurse Attorneys?
A: Yes, we are interested in candidates with a wide-range of educational and professional backgrounds. Nursing and legal experience is very useful at FDA.
Q: When is CDER planning to fill attorney positions?
A: CDER does not hire attorneys, but individuals with legal experience/background can apply for Regulatory Counsel positions.
Q: Are there legal positions currently open?
A: Please look on the www.fda.gov/GDUFAHIRING website, as soon as regulatory counsel positions are open, it will reflect on this page.
Q: Are certain legal backgrounds for attorneys preferred?
A: Different Offices seek attorneys with different expertise. ODSIR, for instance, has a focus on Import/Exports, Supply Chain Security, and Recalls/Shortages. Background in the area of drug law and regulation more generally is helpful as well, but background in other legal disciplines is transferable and may be desirable.
Q: Are Regulatory Counsel position expected to be filled by those holding a JD?
A. No
Medical Officers
Q: Are these positions available to practicing physicians?
A: In the Office of Compliance, physicians (Medical Officers) are hired within the Office of Scientific Investigations, and in CDER, the Office of New Drugs hires Medical Officers.
Q: How big of a need is there for practicing MD's?
A: There is a need in our Office of Scientific Investigations. Please apply to the attached Medical Officer Position. This position can be found by visiting www.fda.gov/GDUFAHIRING
Interdisciplinary Scientist
Q: To which email address or website should someone interested in a full-time Biologist or Microbiologist position that is currently a FDA/ORISE fellow send their resume?
A: CDEROC_recruit@fda.hhs.gov or to apply check out www.fda.gov/GDUFAHIRING and click on the appropriate position
Q: What is the Grade level for interdisciplinary positions?
A: Please check www.fda.gov/GDUFAHIRING website for position details
Q: Which sub-office of OC is more suitable for analytical chemists with experiences in drug product development?
A: Those who have experience with analytical chemistry and drug product manufacturing should apply for Office of Manufacturing and Product Quality positions
Q: Is interdisciplinary scientist the best position for a new graduate with a doctorate in pharmacology, with a research focus on cell and cancer biology?
A: You may qualify for the interdisciplinary scientist position, but you would also qualify for a Pharmacologist GS-405 position as well.
Q: Are biology and chemistry positions available for applicants who only have a bachelor’s degree?
A: Yes.
Q: What are the duties of Microbiologists? When will the Microbiologist position be posted on US jobs?
A: Microbiologists may be hired to function as a review of inspectional findings, help develop guidances on aseptic manufacturing, and other responsibilities.
PHS Commissioned Corps
Q: Are there many PHS officers at the FDA?
A: Yes, there are almost 1000 PHS officers within the FDA
Q: How should a PHS officer apply for jobs?
A: PHS Officers can apply through USAJobs or submit a CV to CDERCommissionedCorpsJobs@fda.hhs.gov . Please be sure to identify which position(s) you are interested in when submitting your CV.
Q: How many PHS officers work within Office of Compliance?
A: There are over 50 PHS officers in OC.
Internships/Pathways Program
Q: Do you have an internship coordinator I could contact if I have specific questions?
A: There are internships available for interested candidates through the Pathways program and the Commissioner’s Fellowship Program. The Pathways program administers internships for current college students, recent college graduates, and Presidential Management Fellows (PMF’s). The Commissioner’s Fellowship Program is a two-year program for scientists, engineers, and healthcare professionals to receive regulatory science training and conduct research on targeted regulatory issues under the mentorship of an FDA senior scientist. The OC Business and Operations staff can assist with questions about the program and eligibility requirements.
Q: Will there be announcements for Pathways Programs released in the near future?
A: Yes, we will announce Pathways program announcements at the following site: www.usajobs.gov/studentsandgrads
Skill Sets
Q: What skills do you look for in candidates?
A: Talented, hardworking individuals with excellent communication skills. Candidates with education and experience in healthcare, science, and engineering who want to make a difference in protecting the nation’s public health. Each sub-office in OC targets candidates with specific experience which fits their mission and program scope.
Q: Which office would be more suitable for an Information Technology Degree.
A: All Office of Compliance sub-Offices may hire individuals with IT degrees.
Loan Repayment Program
Q: Do you have loan repayment program?
A: That program varies on the hiring offices and their availability of funding.
Staff Fellows
Q: Can non-citizens apply?
A: Citizenship is a requirement for permanent positions in the government, and thus FDA. However, opportunities do exist for non-citizens. There are staff fellow positions available for non-citizens in various roles within OC. Non-citizens are encouraged to forward their resumes to the CDEROC_recruit@fda.hhs.gov e-mail address for consideration.
Q: How can I find out staff fellow positions?
A: Explore information concerning the Staff Fellow positions at : http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm 081244.htm
Q: Would a permanent resident physician graduated in the EU and not yet licensed or certified (ECFMG) in the US be able to apply for a medical job at the FDA?
A: Permanent U.S. residents can apply for Staff Fellowship appointments as physicians, scientists, or mathematical statisticians. Graduates of foreign college or universities must provide proof of U.S. education equivalency certification. Staff Fellowships provide opportunities for promising research/regulatory review scientists to advance and enhance their careers through close associations with leading authorities in health-related research. Fellowships also serve to strengthen the research community by facilitating the exchange of talent between the Agency and other research centers. Initial Staff Fellow appointments will be made for up to four years with extensions made on a year-to-year basis or conversion to permanent status, once U.S. Citizenship is obtained.
Recent Graduates
Q: Should new graduates apply for positions?
A: New graduates in scientific, healthcare, and other related backgrounds are encouraged to apply for positions! We have a variety of positions available at a wide range of grades, and all levels of experience are considered.
Q: I am a recent graduate. Where can I find the positions that are available?
A: Please check http://www.fda.gov/GDUFAHIRING for complete lists of positions available, or also search USAjobs.gov for openings at the FDA.
Q: What positions are best suited for recent grads?
A: Those at lower grade levels.
Q: I am planning to complete my PhD in a few months. Is it possible to submit an application for a Consumer Safety Officer before completion of my degree?
A: Potential candidates who will be completing their undergrad or graduate degrees within the next year should apply to the appropriate positions.
Q: Are there openings for recent PhD graduates in molecular biology, cancer related and epigenetic research?
A: Yes, Office of Manufacturing and Product Quality has a biotechnology team as well as other PhD scientist but we do not specifically focus on cancer/epigenetics.
Q: I know you mentioned that you hire recent graduates, is this also the case for recent pharmacy graduates? The USAJOBS posting says you must have at least 1 year of specialized experience.
A: The GS levels are based on education and experience or both. The Direct Hire Pharmacist GS-13 does require the 1 year of specialized experience.
Location
Q: Are there sub-offices outside of the DC area?
A: The Office of Compliance sub-offices are located at FDA headquarters in Silver Spring MD
Q: Are most of your positions in Silver Spring, MD
A: Yes, almost all of Office of Compliance positions are located in Silver Spring.
Q: Are there any available positions (Consumer Safety Officer / Project Management) near the Philadelphia area?
A: The positions are with CDER's Office of Compliance, located at FDA's headquarters in Silver Spring, MD.
Q: Are there any opening in FDA Shanghai site?
A: Please check USAJOBS or with FDA's Office of International Programs.
Q: Are there any job opening in New Jersey?
A: Please check with the New Jersey District Office - www.fda.gov and look for New Jersey.
Q: Are any positions located in the field offices?
A: Please go to www.fda.gov and look for the District Offices.
Q: Will any GDUFA positions be located in the various field offices?
A: Yes - ORA will have CSOs stationed in the field/district offices.
Vacancy Announcements/Job Posting
Q: How do we know about future jobs?
A: The FDA advertises all their available positions on OPM's USAJobs.gov website. You can actually indicate the area of the country where you are interested in to locate a job. FDA Headquarters is located in Silver Spring, MD. For GDUFA specific positions, please visit www.fda.gov/GDUFAHIRING
Q: The USAjobs announcements indicate that you may use education as experience, but when you complete the questionnaire the answers measure on the job experience, doesn't that negate qualifying for the job?
A: The questions that you answer on USA Jobs are used to evaluate your qualifications for the position, however, depending on the position; you can qualify with relevant education. For example, you may have relevant experience from another non-government job that you can refer to.
Q: Will all positions be posted on USAjobs?
A: Yes, they will.
Q: Does FDA offer relocation package?
A: Each vacancy announcement will indicate whether the hiring area is offering relocation.
Q: If I am interested in a position in January 2014, should I apply now or wait until later?
A: You must be fully qualified in education and experience at the time the announcement closes.
Human Resources
Q: After applying how long does it take for decisions to be made about positions?
A: You will usually receive an answer within 30 days after the announcement has closed.
Q: How long will the hiring process take from submission of the application?
A: Hiring in the government can take time and there are many factors that influence the amount of time that hiring for a particular position can take including, but not limited to: the closing date for the position, the number of applicants, and the number of interviews, among others.
Q: What is the interview process like (i.e. is it an all-day interview with multiple people)?
A: The process varies by position/office, but in general you can expect to interview for a few hours with multiple individuals within the recruiting office. Additionally, sometimes an initial interview is conduct and then a follow-up.
Q: It seems that the initial survey placed a large percent of emphasis for the job requisites on various formal education and degrees. Are there circumstances where positions are filled after considering/substituting experience for education?
A: Job announcements should make clear what level of education is required and you must meet the posted educational requirements regardless of your experience.
Q: Is it possible to check the status of an application after the deadline has passed?
A: APPLICATION STATUS INQUIRIES: There should be a phone number and a e-mail address under the "questions about this job" section of the application. This is the means by which an applicant should check the status of his or her application.
Q: Approximately how many individuals are going to be hired under this initiative?
A: GDUFA has an aggressive hiring campaign that will cover several fiscal years.
Q: Should current federal employees apply through a different announcement?
A: Federal government employees can apply to announcements that are advertised for government employees and those open to all US citizens. Refer to the www.fda.gov/GDUFAHIRING page, which will list the links to the vacancy announcements
Q: When will actual hiring begin?
A: We are hiring now.
Q: What was the benefit of sending the resumes in advance if we still have to apply on USAjobs?
A: Sending the resume beforehand allows our business and administrative staff to forward the resumes to our hiring managers. They can then review your resume and make note of your name as a person of interest before they receive the applications from USA Jobs.
Q: Can I apply for more than one position?
A: Yes, you can.
Q: If I have completed a rotation at the FDA, would that be something that is taken into consideration when my application is reviewed?
A: After you have been found to be qualified for a position, then yes, having FDA experience will be assessed by the hiring managers.
Q: Will FDA contact us directly for face to face interview if qualified, what is the hiring procedure?
A: Once the hiring managers receive the CVs, they will review and reach out to qualified individuals to schedule interviews. Once they select a candidate, a hiring package is processed from the hiring office to the FDA Office for Human Resources. The FDA-OHR will extend all tentative and final job offers.
Q: Where can I apply for FDA job opportunities?
A: You can apply for FDA positions at www.usajobs.gov OR check out www.fda.gov/GDUFAHIRING and it will redirect you to USAJobs
Q: Do you think a current federal employee get any kind of preference vs nonfederal employees?
A: No. Certain positions are announced for only federal employees to apply to, however the vast majority of positions are announced and open to all US citizens. All candidates are considered based on their qualifications and experience and current government employment is not typically a requirement.
Q: What does direct hire mean.
A: A Direct-Hire Authority (DHA) is an appointing (hiring) authority that the Office of Personnel Management (OPM) can give to Federal agencies for filling vacancies when a critical hiring need or severe shortage of candidates exists.
Q: Are any of these positions direct hire positions?
A: Medical officers and Pharmacists
Q: Will the application be scored for best qualifying candidates and what score is passable?
A: OPM forwards the Best Qualified applicants. The scores are not forwarded to hiring officials.
Q: I am US citizen but acquired my pre-postdoc education in Europe. I have a hard time getting copies of my transcripts from the original university. Many of my applications to FDA have been turned down for this reason. Is there a solution?
A: See this OPM website for more information on how to transfer foreign degrees: http://www.pmf.gov/become-a-pmf/eligibility/education-outside-us.aspx
Telecommute/Alternative Work Schedules
Q: Do you have jobs for telecommuters?
A: While the FDA does have the ability to offer telecommuting, that is typically not offered to new employees until after a performance rating period that results in a good rating.
Q: What is FDA's policy regarding teleworking or alternate work schedules?
A: FDA has a wide-variety of teleworking and alternate work schedule opportunities available for employees to request participation. Specifically in CDER, opportunities exist for employees to work multiple days per pay period from home. The nature and content of the position and work of the position are always consider, and employees work closely with their supervisors to find the best schedule that works for them and their position
What to expect from FDA
Q: Does the FDA implement the principles of Lean Six Sigma throughout the organization?
A: To ensure high quality, consistency and accountability in our regulatory operations, the Center for Drug Evaluation and Research (CDER) within the FDA, is committed to establishing processes based on quality management principles. These principles will also help achieve operational goals that support CDER’s mission. CDER must develop effective and efficient ways to meet our increasing public health responsibilities and stakeholder needs. This requires that we leverage existing resources while increasing value to achieve operational excellence. CDER is actively planning and implementing an approach based on Quality Management System principles and the use of Lean management methodology to accomplish this. The Lean Management Staff (LMS) within CDER is a team of full-time employees charged with facilitating process improvements across CDER, inspiring meaningful change in a large federal organization, and transferring knowledge about Lean principles and tools throughout CDER. Lean principles have been critical in streamlining processes and improving efficiencies so that CDER can better promote and protect public health.
Q: What type of career longevity can we expect working for the FDA?
A: Many of our employees that join FDA spend their entire professional careers at the agency. Kathleen Anderson - who is speaking now - has been with CDER Office of Compliance for 23 years! Many of our senior level employees started as CSOs or other positions within Compliance, CDER, or FDA. The type of work that is done here is very meaningful and provides a large amount of professional satisfaction. It is not uncommon for employees to spend their entire career at FDA. Likewise, there are a number of work-life programs at FDA that add personal enrichment to our employee’s professional careers.
Q: Can you describe the culture of your organization?
A: The Office of Compliance has a strong workforce culture with a team-oriented environment. Our mission is to protect the public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
Q: By attending this Virtual Hiring Event, how are we better able to attain a position at the FDA?
A: You are more familiar with the Office of Compliance and our mission and structure, which should help you identify what sub-Office you would most like to work for. You also should now have a good understanding of the available positions listed on www.usajobs.gov and www.fda.gov/GDUFAHIRING
Q: Is International travel required?
A: In certain areas of the Office of Compliance, there is required travel and some of that is international.
Q: For internal staff is there another way of applying for the jobs other than USAjobs?
A: No
Q: Can we expect any response to a resume we submitted to the CDER OC hiring mailbox/email?
A: An acknowledgement email will be sent containing more information on how to apply.
Q: Does your company have formal training programs, or do employees receive on-the-job training? Who is eligible?
A. Yes, there is structured training available, mentoring and on the job training.
Q: Has GDUFA had an impact on OC in terms of workload? Would you say increased, decreased or about the same?
A: We anticipate that GDUFA will significantly increase the workload in OC, specifically in OMPQ and OSI.
Q: I am not a US citizen and currently I am holding H1B visa, can I apply for the FDA job openings?
A: An individual who is not a citizen or national of the United States may not compete for or be appointed to a position in the competitive service.
Q: Currently, the applicant is a green card holder, and is planning to get US citizenship next year. Is the green card holder eligible to get a position?
A: An individual who is not a citizen or national of the United States may not compete for or be appointed to a position in the competitive service.
Q: If you are waiting on your license number would you still mark non- licensed on the application?
A: You must have received your license/license number to mark as licensed.
Q: When completing the job questionnaire, at times I wonder how to find a balance between presenting my qualifications fully and not-overstating them. What do you consider overstating a qualification?
A: Honestly state your qualifications please make sure you are stating your exact qualifications based off of your knowledge and skills.
Other hiring events
Q: Will you be on campus to interview or host other events?
A: Interviews can take place remotely and in person at the FDA campus. OC also maintains a presence at local and national recruiting events.
Q: Will there be more CDER Virtual Hiring Events in the future?
A: We hope to have more events. All upcoming events will be posted on the GDUFA website. www.fda.gov/GDUFAHIRING
Q: Will the FDA be hosting any upcoming university on-campus hiring events in the DC area?
A: John Hopkins University has an event coming up in September 2013. Please see JHU’s website for more information.