Health IT Consultant

6 days ago

Silver Spring, Maryland, United States Vector Consulting, Inc Full time

Vector Consulting is looking for an experienced
Health IT Consultant
on a remote 9+ months (part-time) renewable Government contract in
Silver Spring, MD
.
Position:
Health IT Consultant
This individual will work across various clinical projects across the agency supporting the responsibilities below:

  • Participating as a subject matter expert for any clinical safety studies, respectively, which are submitted to the agency 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

  • Minimum of a MD or PhD
  • Minimum of 5 years experience as a reviewer scientist working on drug applications of various types OR pharma background with PI/study director/study investigator experience
  • Understanding of agency organization and clinical drug safety review process
  • Wide breadth of understanding of various medical specialties such as oncology, cardiology, internal medicine
  • Exposure to CDISC standards and PHUSE working groups
  • Demonstrated capacity to harness safety analysis tool technologies in the service of conducting drug safety review activities

Additional Desired Skills And Experience

  • Experience with clinical analytical tools such as MAED (or other Adverse Events Analysis Software), JMP/JMP Clinical, Pinnacle21 Data Validation Engine, and SAS
  • Experience with data standards such as CDISC Data Standards (SDTM/ADaM) and MedDRA
  • Strong project management skills
  • Experience with clinical informatics and the IT systems that support them
  • Experience leading clinical trials and shaping clinical trial design
  • Experience with conducting drug safety reviews and drug safety analyses
  • Experience working with medical reviewers
  • Experience with drafting information requests (IRs) from agency and/or responding to them on behalf of industry

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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