Lead Regulatory and Safety Specialist

Summary

This position is located in the Office of Sponsor and Regulatory Oversight (OSRO), Office of Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (HHS).

This job is open to

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This job is also open to USPHS Commissioned Corps Officers and Call-To-Active Duty (CAD) Candidates.

Duties

Provide regulatory guidance, safety oversight, operational support, and inspections to ensure the clinical trials conducted under IND or IDE are developed and conducted by the CCR in compliance with regulations and industry best practices.

Serve as a Team Lead for internal safety oversight staff as well as provides oversight and serves as the COR representative for the safety oversight section of the support contract.

Ensure that the organization's strategic plan, mission, vision and values are communicated to the team and integrated into the team's strategies, goals, objectives, work plans and work products and services.

Manages Serious Adverse Event (SAE) reports: reviews and processes SAE reports and conducts follow-up; notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies and collaborators; reviews scientific literature and bibliographic sources; assists with drafting, produces and manages safety reports; evaluates safety profiles; and ensures document filing and archiving. Recommends action based on identified risks.

Manages Data and Safety Monitoring Board (DSMB): oversee the assembly, operations and data review of CCR DSMBs.

Supports maintenance of safety trackers and databases. Collaborates with Medical Monitors in activities of review, assessment, summarization and reporting of serious adverse event information.

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 Education. Please submit transcript(s).

Qualifications

In order to qualify for a Lead Regulatory and Safety Specialist, GS-0601, position you must have successfully completed a bachelor's degree or graduate/higher level degree with 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).

In addition, in order to qualify for a Lead Regulatory and Safety Specialist, GS-0601-14, you must have at least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing leadership and guidance on regulatory and safety requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications; providing guidance on regulations, policies, and procedures governing clinical trials regulatory and safety issues; preparing reports on clinical trials regulatory and safety issues; and providing leadership and direction to other staff in accomplishing work activities.

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. .

Additional information

This position is designated as a "" position and the selected candidate will be considered a "" employee. In the event of a closure, you must be available to telework or request leave.

A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.

A one-year probationary period may be required upon selection/placement.

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 within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.

The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program . E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

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 our for helpful information on the application process.

Visit our page and this for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

1) Ability to lead and direct the work of other staff.

2) Skill in managing pharmacovigilance activities for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.

3) Skill in managing safety oversight of pharmacovigilance activities.

4) Ability to prepare reports and documentation on clinical trials regulatory and safety issues.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

Best Qualified - for those who are superior in the evaluation criteria

Well Qualified - for those who excel in the evaluation criteria

Qualified - for those who only meet the minimum qualification requirements The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

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 by scoring at least an 85 on the assessment 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 . 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)

If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

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 PREFERENCE OR ELIGIBILITY CLAIMS

To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

(DD-214, VA Disability Letter, etc.): Reference for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the is submitted with your application package.

Visit our sites on / for more information and required documentation.

Visit our site on the for more information and required documentation to verify eligibility.

Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.

Do not submit 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.