Major Field of Study:Business Administration, Healthcare Administration, or a related field
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:36
Accept Alternate Job Title:Related position in the pharmaceutical industryregulatory affairs.
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills: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.