Monday, June 27, 2011

QC/QA Officer-Job Code: CIK-1972

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Provides scientific input for development of clinical research strategies, operational projects, regulatory authority questions within his/her area of responsibility and operational programs.Writes scientific content of clinical program documents such as clinical development plan, regulatory documents, and publications for Investigator Meetings,Adjudication Board, Data Safety Monitoring Boards, IND annual report and Health authority briefing books and submissions, etc.Executes non-operational individual clinical studies in alignment with the approved clinical development plan and under highest quality standards. Plans and monitors timelines, resources and budgets for the scientific part of the clinical program: e.g. Medical Writing, Advisory Boards, etc.Contributes to multidisciplinary task forces to support continuous improvement: i.e. quality circles, SOP harmonization.
Keywords:"QC Officer", "QA Officer"