Under direct supervision the incumbent is responsible for assisting the Scientific Affairs Department with performing Publishing and formatting of US and Ex-US regulatory submission documents to ensure that they follow clients style and publishing guidelines.
- Providing support and technical assistance for publishing and formatting of regulatory submission documents
- Working in Adobe Acrobat using advanced features such as OCR, File Optimization and bookmark and link auditor
- Coordinate with Submissions Team and authors to ensure submission documents are formatted processed and submitted on-time
- Compiling and publishing eCTD sequences using an eCTD building/compilation software as needed
- Performing detailed QC of eCTD and paper submissions processed internally and by external vendors
- Providing support as needed to Regulatory Affairs/Operations personnel
- Administering routine file management and maintaining submission logs and files
- Performing routine submission publishing activities associated with electronic and hard copy submissions
- Work closely with cross-functional team members and Submissions Team to compile documents needed for a submission, manage version control, and track documents for assigned projects
- Process paper submissions for INDs, NDAs, BLAs, and ODAs per FDA/ICH guidelines and FDA's current thinking stated at conferences and submit to the Agency
- Responsible for formatting Word documents by applying appropriate styles/templates
- Formatting PDF documents using Acrobat and ISI Toolbox that include aspects of publishing activities involving bookmarking, hyper linking, and other requirements to ensure compliant electronic documents
- Coordinate with contracted publishing vendors for outsourced electronic submissions and maintaining submission logs
- QC eCTD and paper submission published outputs for all required submission per Agency requirements
- Support Pharmacovigillance with submissions sent through the electronic system gateway (ESG)
- Manage the tracking of submission documents between authors and the Submissions Team (both internal and external vendors); duties include updating document trackers, uploading to and downloading from portals, and maintaining portal folders with support of the Submissions Team.
- Support the Submissions Team for archiving Regulatory Agency documents, including submissions, letters, and contact reports, in the Document Management System and on the internal drive
- Organize and maintain folder structures in the document management system, internal drive, and client portals
SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY:
- Bachelor's Degree or country equivalent with 5 years of regulatory/regulatory operations experience preferably within a healthcare environment. Scientific or related discipline would be an advantage.
- Expert working knowledge with submission publishing concepts, guideline and industry Best practices
- Experience and knowledge in CTD (paper and electronic) granularity and proficiency in word processing of authored documents.
- Knowledge of nonclinical, clinical, and CMC submission documents
- Expert working knowledge of MS Word Templates, word processing, styles and their function and use.
- Proficiency in MS Office applications, Adobe Acrobat plug-ins such as ISI Toolbox and pre-publishing activities (including bookmarking, linking, and editing); submission publishing experience for both paper and electronic submissions is a must
- Ability to manipulate text with the use of MS Word Styles and formatting techniques.
- Strong knowledge of FDA and ICH regulations and guidelines related to paper and eCTD submissions
- Attention to detail and ability to support multiple projects
- Technical system skills (e.g. strong familiarity with DMS, file organization, ISI Toolbox, Adobe Acrobat, MS Word Templates)
- Excellent oral and written communication skills
- Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems
- Ability to work independently and in a team environment
Green Key Resources is a premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, alternative asset management, information technology, office/legal support and human resources.
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Sat, 9 Sep 2017 10:51:54 PDT