Pharmacologist (Technical Project Lead Coordinator)

Food and Drug Administration • Silver Spring, MD

1d • Hybrid

About The Position

The Pharmacologist (Technical Project Lead Coordinator) serves in the FDA’s Center for Tobacco Products, Office of Science, Division of Individual Health Science. The Center is responsible for implementing the Family Smoking Prevention and Tobacco Control Act of 2009. The role leads a multidisciplinary review team assessing premarket applications for proposed new tobacco products, and provides authoritative recommendations and guidance to other Center review organizations, review scientists, and regulated industry. The position develops Technical Project Lead Review reports and provides technical support, clarifications, and edits to the rationale and justification for marketing orders for products under review. This is not a fully remote position; the selectee must report in person regularly to a designated FDA facility in accordance with agency telework policy.

Requirements

• U.S. citizenship, unless an exception is explicitly stated.
• Meet the applicable time-in-grade requirement for GS-14 by the announcement closing date.
• A degree with a major in an appropriate biological, medical, veterinary, or physical science, or in pharmacy including at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
• At least one year of specialized experience equivalent to GS-13, including assessing premarket applications for proposed new tobacco products and drafting scientific reviews for application pathways such as PMTA, SE, EX, or MRTPA.
• Pass a security investigation and, if tentatively selected, a pre-appointment drug test with a negative result.
• Submit required supporting documentation, including transcripts and applicable federal employment documentation.

Responsibilities

• Lead a multidisciplinary review team assessing premarket applications for proposed new tobacco products.
• Provide authoritative recommendations and guidance to other Center review organizations, review scientists, and regulated industry.
• Develop Technical Project Lead Review (TPLR) reports.
• Provide technical support, clarifications, and edits to the rationale and justification for marketing orders for products under review.

Benefits

• Federal employee benefits package available to eligible employees and their families; specific benefits depend on position type.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior