Health IT Consultant

Job Description

Description

This individual will work across various clinical projects across the FDA Office of Computational Sciences supporting the responsibilities below :

• Participating as a subject matter expert for any clinical safety studies, respectively, which are submitted to the FDA in support of drug applications.
• Reviewing clinical data for regulatory compliance to ensure human subject safety and data integrity and communicating findings with a multi-disciplinary review team.
• Completing special projects that involve specific research areas and objectives to include the design, characterization, performance, and bioequivalence of complex drug products; development of advanced manufacturing approaches for drug substances and drug products; development of science-based drug quality standards; and the development of analytical and in-vitro methods to support product quality surveillance and investigate product quality failures.
• Serving as a CDER resource by participating in work groups or subcommittees.
• Publishing scientific articles within the scientist's area of expertise and maintaining contact with the "state of science” to identify and integrate the most advanced research theories and / or practices into the Center's drug regulatory programs.

Essential Skills and Experience :

Additional Desired Skills and Experience :