Summary

This position is located in the Office of Pharmaceutical Research Management (OPRM), Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS).

Duties

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As an Pharmaceutical Product Specialist, your duties will include but are not limited to the following:

• Manage a portfolio of clinical sites in collaboration with other pharmacists.
• Ensure study participant safety by reviewing, processing, analyzing study product issues and complaint documents received.
• Receive, approve, and process product returns and destructions in collaboration with clinical study sites and research pharmacists.
• Determine investigational product cost and assesses potential savings to the institute.
• Obtain study team approval to purchase investigational product for use in clinical trials.
• Analyze CPC invoices, update relevant racker, and predict fund shortage or overage.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Position requires Education. (You are encouraged to upload your transcripts)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.

Qualifications

To qualify for the Pharmaceutical Product Specialist GS-601, you must meet the following qualification requirements:

Education Requirement: You must possess a Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. AND

Additional Qualifications:

To qualify at the GS-09 level, you must meet one of the following qualification requirements:

1. Completed 2 years of progressively higher-level graduate education leading to a master's degree or, have a master's or equivalent graduate degree in a related field; OR
2. Have at least one year of specialized experience equivalent to at least the GS-7 level in Federal Government obtained in either the private or public sector, performing the following types of tasks: assisting in pharmaceutical, operational, and administrative tasks for managing study product inventory for clinical trials; assisting in procurement, purchasing, and services to support pharmaceutical operations; and performing administrative services to support pharmaceutical and program operations and issues: OR
3. Have a combination of post baccalaureate education and experience that meets 100% of the qualification requirements for this position.

To qualify at the GS-11 level, you must meet one of the following qualification requirements:

1. Completed 3 years of progressively higher-level graduate education leading to a Ph.D. degree or, have a Ph.D. or equivalent doctoral in the related field; OR
2. Have at least one year of specialized experience equivalent to at least the GS-9 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: performing clinical trial administration and product management activities; providing information on pharmaceutical products and utilization clinical staff for clinical trials; overseeing clinical sites to ensure study product issues and complaints are mitigated; and implementing pharmaceutical programs and operations for clinical trials; OR
3. Have a combination of post graduate baccalaureate education related to the position and experience that meets 100% of the qualification requirements for this position.

To qualify at the GS-12 level, you must have one year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: managing clinical trial study products and clinical site activities; developing reports on the evaluation and audit of clinical sites; collaborating with external companies and distributors on pharmaceutical procurement and purchasing services for study products; and developing policies and procedures for administering pharmacy and pharmaceutical programs and operations to support clinical trials.

You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.

Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer.

Preview assessment questionnaire before you apply:

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

If you qualify based on education in lieu of specialized experience, you are strongly encouraged to submit a copy of your transcripts or a list of your courses including titles, credit hours completed and grades. Unofficial transcripts will be accepted in the application packages. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Additional information

• This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
• At the supervisor's discretion, this position may offer work schedule flexibilities: telework compressed schedules, flexible schedules.
• Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/fd.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
• We may make additional selections for similar positions across the National Institutes of Health within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at NIH. Clearance of CTAP will be applied for similar positions across NIH.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• Visit Help Applying for helpful information on the application process.
• If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation Information
• Veterans' Preference only applies to Schedule A (disability appointment), HHS Reemployment Priority List (RPL) Eligibles, HHS Priority Reemployment List (PRL) Eligibles, and Veterans Recruitment Appointments (if applicable).

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

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Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.