Clinical Health IT Consultant / SME
Posted 1 day ago by 1756881889
Negotiable
Outside
Remote
USA
Summary: Vector Consulting is seeking a Health IT Consultant/SME for a remote, renewable government contract lasting 6-12 months. The role involves supporting clinical projects at the FDA Office of Computational Sciences, focusing on regulatory compliance and safety studies. Candidates must possess a minimum of a MD or PhD and have at least five years of experience as a reviewer scientist in drug applications.
Key Responsibilities:
- Participating as a subject matter expert for clinical safety studies submitted to the FDA.
- Reviewing clinical and nonclinical data for regulatory compliance to ensure human subject safety and data integrity.
- Evaluating nonclinical sections of product labeling and making regulatory recommendations.
- Completing special projects involving research areas related to drug products and quality standards.
- Serving as a CDER resource by participating in work groups or subcommittees.
- Publishing scientific articles and integrating advanced research theories into drug regulatory programs.
Key Skills:
- Minimum of a MD or PhD.
- Minimum of 5 years experience as a reviewer scientist on drug applications.
Salary (Rate): undetermined
City: Silver Spring
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Vector Consulting is looking for an experienced Health IT Consultant/SME on a remote 6-12 months renewable Government contract in Silver Spring, MD. Position Health IT Consultant/SME DESCRIPTION OF PROJECT AND TASKS:
This individual will work across various clinical projects across the FDA Office of Computational Sciences supporting the clinical aspects of the responsibilities below:
Participating as a subject matter for any clinical safety studies, respectively, which are submitted to the FDA in support of drug applications.
Reviewing clinical and nonclinical data for regulatory compliance to ensure human subject safety and data integrity and communicating findings with a multi-disciplinary review team. Evaluating nonclinical sections of product labeling and making regulatory recommendations.
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 Centers drug regulatory programs. Qualifications:
Minimum of a MD or PhD
Minimum of 5 years experience as a reviewer scientist working on drug applications of various types About Vector:
Vector Consulting, Inc., (Headquartered in Atlanta) is an IT Talent Acquisition Solutions firm committed to delivering results. Since our founding in 1990, we have been partnering with our customers, understanding their business, and developing solutions with a commitment to quality, reliability and value. Our continuing growth has been and continues to be built around successful relationships that are based on our organization's operating philosophy and commitment to ** People, Partnerships, Purpose and Performance - THE VECTOR WAY Celebrating 30+ years of service
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