特殊技能:FOUR 4 YEARS OF EXPERIENCE WITH THE FOLLOWING EXPERIENCE MAY BE GAINED CONCURRENTLYbr EXPERIENCE WITH REGULATORY PROCESSES AND SYSTEMS;br PHARMACEUTICAL, BIOTECHNOLOGY REGULATORY OPERATIONS INDUSTRY EXPERIENCE;br KNOWLEDGE OF GLOBAL ICH INTERNATIONAL COUNCIL FOR HARMONIZATION GUIDELINES AS THEY PERTAIN TO ECTD ELECTRONIC COMMON TECHNICAL DOCUMENT PUBLISHING AND SUBMISSIONS.br br THREE 3 YEARS OF EXPERIENCE WITH THE FOLLOWING EXPERIENCE MAY BE GAINED CONCURRENTLYbr EXPERIENCE IN CUSTOMER AND BUSINESS RELATIONSHIP MANAGEMENT;br KNOWLEDGE OF NEES NONECTD ELECTRONIC SUBMISSIONS SUBMISSION GUIDELINES;br EXPERIENCE MANAGING CROS CONTRACT RESEARCH ORGANIZATIONS;br DOCUMENT MANAGEMENT AND PUBLISHING SYSTEMS AND ANY RELATED SUPPORT TOOLS SUCH AS LORENZ EVALIDATOR OR ISI TOOLBOX;br KNOWLEDGE OF ANY REGIONAL REQUIREMENTSGUIDELINES FOR GEM PUBLISHING AND SUBMISSIONS.br br WILL ACCEPT ANY SUITABLE EQUIVALENT COMBINATION OF EDUCATION, TRAINING, AND EXPERIENCE.br br POSITION OFFERS OPTION TO TELECOMMUTE FROM A HOME OFFICE AND WAS ADVERTISED AS SUCH.