Overview
Remote
Depends on Experience
Contract - W2
Contract - 2 week(s)
Skills
HealthIT_Analyst / SME
Job Details
Vector Consulting is looking for an experienced Health IT Consultant/SME on a remote 6+ 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 Center’s 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”
#LI-RD1
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 Center’s 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”
#LI-RD1
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