*Position: S-Cubed **Regulatory **Publisher* *Location: Princeton,NJ*
*Contarct: 24 Months* *Interview Process- Phone and Skype * *Job Description* 4 Years Submission Publishing experience - Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems. - Demonstrate ability to function autonomously in a matrix environment. - Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions. - Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal skills. - Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. - All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. - Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents. *Role:* - Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure. - Support Global Regulatory Leads in the planning, development, and publishing of submissions. - Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted. - Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers. - Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch. - Dispatch submissions through the FDA Gateway - Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application. - Archive submissions both electronic and paper. *In case this position interests you and you are looking for a job change, please share below details to save on you valuable time;Pay rate expectations:Notice period:Work Authorization status:Current Location:Also share your updated resume to me* -- *--Thanks & Regards,Vikas Kumar Singh* *Okaya InfocomPh: 631-267-4883 Ext: 302Email: vikas.si...@okayainc.com <vikas.si...@okayainc.com>* -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
