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Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
I am pursuing a role in the Clinical or Regulatory Affairs group as a specialist. I was a manager but I would prefer to be an individual contributor in either department.
Summary Senior CRA with regulatory submission responsibilities, worked in CRO at local level within single/multicentric Clinical Trials (phase 1-3 and Bioavailability Studies) and coordinating all process: feasibility studies, sites identification, contracts negotiations with PI/hospital administration, collection of documents and CT dossier preparation, submission to Regulatory Agencies, preparation/submission of Amendment...
part-time work-at-home clinical data entry
I am a project/administrative coordinator with 4 years experience in hospital administration and close to 15 years of overall Healthcare experience including document specialist and medical transcriptionist.
Recent CWRU graduate - MA in Bioethics, Clinical Research Concentration. Experienced Regulatory Affairs/Compliance Specialist (FDA, DOI, NIH, OIG, OSHA). Extensive knowledge of IRB processes, including SpartaIRB Protocol. Assisted in several CWRU IRB quality improvement and review processes. Proficient in education/training methods and electronic presentations. Extensive experience writing and monitoring policies and proce...
SUMMARY Professional with over twenty five years of broad-based experience in risk management ensuring that the health and safety of employees, the public, and the environment are maintained to the strictest of standards by taking a proactive, rigorous, value-added approach employing strategic vision and innovation while practicing fiscal stewardship. Undertakings include laboratory, facility and manufacturing regulatory co...
Tags for this Online Resume: ISO, Management, Program Manager, Quality, Quality Assurance, Quality Management, Manufacturing, Risk Management, Distribution, Integrate, Root Cause, Compliance, Corrective Action, Safety, Environmental, 14001, Team, EHS, GMP, Laboratory, Leader, Pharmaceutical, Biotech, due diligence