Hi I have an urgent requirement of '*eCTD *Regulatory Publisher' please send me your resumes along with your contact details.
*MUST BE A USC OR GC HOLDER* *Position :** eCTD *Regulatory Publisher *LOCATION :**Tarrytown, NY* *DURATION: 9-12 months* *INTERVIEW: phone screen; face-to-face required/Skype* *START DATE: 3/10/2014* RATE - $45/hr *Position Summary:* Responsible for formatting and publishing electronic documents for Regulatory submission deliverables such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). *Responsibilities:* * Formats and publishes electronic Regulatory submission documents and ensures quality, accuracy, and submission readiness per Regulatory agency guidance and specifications, and internal procedures. QCs others work. * Assists with developing and maintaining document formatting and publishing procedures, standards, and specifications * Provides guidance on good documentation and submission practices * Identifies and communicates regulatory system enhancement needs or technical issues * Assists with regulatory inspection activities * May provide StartingPoint eCTD authoring template training. * Collaborates with vendors who support Regulatory submission document related tasks. *Experience and Required Skills: * *Requirements:* * Bachelor's Degree * 3-5 years of experience * Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). * Can work independently (some guidance from direct manager anticipated), ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills. * Strong knowledge with Microsoft Word, Adobe Acrobat, and electronic document management systems (SharePoint preferred) are required. Working knowledge of eCTD authoring templates (StartingPoint preferred) and document publishing tools (ISIToolbox and A-Pulse preferred) are required Thanks and Regards Andy Talent Acquisition Team Glomark International LLC Direct: 908-333-5191 Fax: 908-688-8831*Email: *a...@glomark-llc.com / *Gtalk: * *glomarka...@gmail.com* <glomarka...@gmail.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 http://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/groups/opt_out.
