Summary
The NIH CC Pharmacy is seeking an exceptionally talented, knowledgeable, and motivated Pharmacist for the Investigational Drug Control Unit (IDCU). The ideal candidatewill have experience supporting clinical trials with protocol development and consultation, protocol review and investigational drug information, inventory management, record keeping, and quality assurance.
Duties
Investigational drug development and clinical trials are important aspects of the NIH Clinical Center's research program. To support these research efforts, the Pharmacy Department is involved in the quality control, dispensing, and clinical monitoring of both non-investigational and investigational medications.
As a GS-0660-13, Pharmacist with the NIH Clinical Center's Pharmacy Department Investigational Drug Control Unit, your duties will include but are not limited to the following:
- Attending site initiation visits, site qualifying visits and protocol start-up meetings as needed.
- Coordinating all activities related to the management of investigational drugs by the NIH Clinical Center.
- Researching the marketplace for commercial drug availability for use in the protocol, providing guidance to investigators regarding the availability of commercial drugs, and making recommendations on the need to obtain commercially available drugs.
- Identifying key projects related to investigational drug management and is accountable for coordinating the implementation of these projects system-wide.
- Identifying and providing pharmacy requirements related to products supplied by Contract Manufacturing Organizations (CMOs) and compounding pharmacies.
- Making authoritative determinations on conformance with requirements; and coordinating corrective actions or adjustments with the section reviewed.
- Acting as a liaison to other department representatives by informing and instructing them on the myriad aspects of protocol initiation and implementation.
- Researching up-to-date regulations and technologies to ensure the clinical trials and compliant and efficient.
Requirements
Conditions of Employment
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
- Applicants must meet all qualification requirements by the closing date of this announcement.
- Males born after December 31, 1959 must be registered with the Selective Service.
- Position requires License, and you are asked to submit a copy of your Pharmacist license with your application.
- If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
- A one-year probationary period may be required upon selection/placement.
- 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.
- Some work may require periods of walking, standing, and bending in offices, laboratories, hospitals, treatment facilities, and other work areas. The incumbent may frequently carry light items such as instruments, and other similar materials.
- The work area normally involves everyday risks or discomforts requiring normal safety precautions typical of offices and may involve occasional exposure to conditions in facilities or hospital settings requiring safety precautions.
- Must be able to distinguish basic colors.
- At the supervisor’s discretion, this position may offer work schedule flexibilities: telework.
Qualifications
To qualify for a Pharmacist (Investigation Drug Control Unit), GS-0660, you must have:A. A doctoral degree in Pharmacy that is recognized by the or an accrediting body recognized by the at the time the degree was obtained;
OR
B. A bachelor's degree in Pharmacy and a substantial record of experience and achievement that demonstrates competence in the pharmacy field. Individuals who qualify based on this option will be subject to a comprehensive evaluation of both their education and experience prior to final appointment.
AND
License: An active current license as a pharmacist in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
ADDITIONAL QUALIFICATIONS:
In addition, in order to qualify for a Pharmacist (IDCU), GS-0660 at the GS-13 level, you must have at least one year of professional pharmacy experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing recommendations on the development and administration of internal surveillance and evaluations to assure conformance with plans and procedures; developing and implementing drug information activities and systems, modifying or adapting standard operating procedures; conducting literature evaluation, formulation of recommendations and initiatives, coordination of intervention strategies, and monitoring of study drug information activities; and offering advice on drug accountability aspects that are critical for investigators to be in compliance with applicable federal laws.
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:
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
The position(s) advertised in this announcement are covered by a direct hire authority. Traditional rating and ranking of applicants, including category rating, does not apply to this vacancy. You will be initially evaluated against the basic qualifications only. Qualified applicants will be referred for consideration in accordance with the . Veterans' Preference does not apply to positions covered by a direct hire authority.
To be considered well qualified for the purposes of the and the , you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications and meet all eligibility, physical, medical, suitability, and all other requirements.
Required Documents
REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.
To ensure all of the essential information is in your resume, we encourage you to use the r. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:
- Job title
- Name of employer
- Beginning and ending dates of employment (month/day/year format)
- Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
- Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
- Series and grade or equivalent (if a federal position)
Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
For resume writing guidance, please visit the following resources: , , and the .
ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.
Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.
REQUIRED DOCUMENTATION FOR CAREER TRANSITION CLAIMS
Visit our websites to claim selection priority through the Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP):
- CTAP:
- ICTAP:
Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from .
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.