Lead Regulatory and Safety Specialist

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.

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.

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.

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.