Medical Documentation Specialist (Pleasanton, CA)

Medical Documentation Specialist

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co m Medical Documentation Specialist needs 5 year s work experienceMedical Documentation Specialist requires Experienced in an FDA regulated medical device manufacturing environment or pharmaceuticals is preferred. Proficient in the use of EDMS and ELMS experiences with Arena PLM Veeva ComplianceWire and Trackwise are desirable. Ability to focus on and achieve scheduled milestones multi-tasking and contingency planning. Knowledge of QSR MDSAP EUMDR 13485 2016 and 14971 2012. Competent using office software including MS Word Excel Internet Explorer PowerPoint and Outlook. Ability to define problems collect data establish facts draw valid conclusions and report on findings Ability to read technical literature and documents and extract important concepts. Ability to apply concepts such as fractions percentages ratios and proportions to practical situations. Ability to use MS Excel to perform calculations and interpret results data. Medical Documentation Specialist duties Use of the Electronic Product Lifecycle Management (PLM) Electronic Document Management system (EDMS) and Electronic Learning Management system (ELMS) systems for document control and training ensuring that it is appropriately maintained supported and effectively used. Ensure efficient processing of change orders and documents in the electronic PLM and EDMS systems. Create and maintain user groups user assignments instructor led-trainings and e-learnings in the ELMS. Provide regular updates to the management on systems processes and projects escalate unresolved issues in a timely manner. Provide training and guidance in the areas of responsibility for internal customers. Manage controlled document and record archiving area and associated electronic systems.