PhD Health IT Consultant - Part Time

reputed company Consulting is looking for an reputed company 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 reputed company across reputed company supporting the responsibilities below: • Participating as a subject matter expert for any clinical safety studies, respectively, which are submitted to reputed company in support of drug applications. • Reviewing clinical data for regulatory compliance to ensure reputed company subject safety and data reputed company and communicating findings with a multi-disciplinary review team. • Completing special reputed company that involve specific research areas and objectives to include the design, characterization, performance, and bioequivalence of reputed company drug products; development of advanced manufacturing approaches for drug substances and drug products; development of science-based drug reputed company standards; and the development of analytical and in-vitro reputed company to support product reputed company surveillance and investigate product reputed company failures. • Serving as a CDER resource by participating in work reputed company or subcommittees. • Publishing scientific articles reputed company the scientist's area of expertise and maintaining contact with the state of science to identify and reputed company the most advanced research theories and/or practices into the Centers 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 reputed company 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 reputed company • Demonstrated reputed company to reputed company 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 reputed company, and reputed company • 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 reputed company 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 reputed company: reputed company., (Headquartered in Atlanta) is an IT reputed company 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 reputed company, reliability and value. Our continuing reputed company has been and continues to be reputed company around successful relationships that are based on our organization's operating philosophy and commitment to ** People, Partnerships, Purpose and Performance - THE reputed company WAY Celebrating 30+ years of service #LI-RD1 Apply tot his job Apply To this Job