对应专业:Business Administration, Healthcare Administration, or a related field
所需培训:N
培训时长:
所需培训领域:
前置经验:N
经验时长（月）:
替代领域学历:N
替代专业:
可替代教育及经验组合:N
所需教育层级:
其他可替代教育层级:
认可经验年限:
境外教育背景:Y
可替代职业:Y
可替代职业时长（月）:36
可替代职业名称:Related position in the pharmaceutical industryregulatory affairs.
是否为正常职业要求:N
是否需要外语:N
特殊技能:Must also have any experience with or knowledge of i electronic datadocument management, project management, computer systems or publishing software support, electronic document publishing, andor regulatory affairs; ii drug development process and relevant Standard Operating Procedures with an understanding of federal regulations, international standards e.g. ICH, and regulatory guidelines as they pertain to the development and filing of esubmissions; iii interpreting implications of regulations, applying them to daily operations, and responding appropriately to questions from peers and cross functional professional staff; iv word processing, document management, and desktop publishing software packages, including handson knowledge of various document types, authoring tools, and file formats MS office templates, PDF file rendering, SAS programtransport files, XML program code, etc.; v document management or electronic publishing tools; vi eCTD technical and validation requirements, as per ICH, FDA, EMA guidance, for publishing dossiers for the registration and lifecycle maintenance of medicinal products; vii publishing Study Data Standards Datasets according to the US FDA requirements and technical validation criteria; viii publishing Advertising and Promotional Materials in eCTD format; ix using eCTD publishing tools, preferably docubridge, and electronic document management systems; x evaluating and validating new software functionality and ITsystems used in the electronic submission process in order to keep up with evolving Health Authority regulations as well as for process improvement and efficiency initiatives; and xi training on the submission specialist publishing tasks and document authoring and workflow processes.br br Experience can be concurrent.br br This position is remote within the United States, but travel to Bayers Whippany, NJ, office for meetings or projects may be required. Associated travel expenses will be the employees responsibility.br br Note Since there is no experience required in H.6 the Kellogg language is not required.