Regulatory Scientific Reviewer (Pharmacologist)

Plans and carries out the assignments, resolves most technical conflicts, and leads multidisciplinary teams to address high-impact, controversial, or precedent-setting issues within their designated area of expertise. Advises on specialized research initiatives, and product-specific protocols. Assures that legal and policy considerations are adequately addressed, as well as purely technical matters. Assumes responsibility for a team effort to resolve complex or regulatory significance of issues and problems relating to the area of assignment. Coordinates the assignments with interested parties internal and external to the Agency and integrates it into the broader regulatory programs of the FDA. Make recommendations that go to the supervisor, team leads, branch chief etc. for directors' concurrence.