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REMOTE Regulatory Information Management Archives Consultant

Company: Hallmark Global Technologies
Location: Yonkers
Posted on: November 20, 2020

Job Description:

Job Title Regulatory Information Management Archives Consultant Job Location Tarrytown, NY (Remote) Project End Date 12312021 Summary Responsible for archiving (categorizing and classifying information) Regulatory records pertaining to multiple Regulatory Applications (INDs, BLAs, etc.), maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed. Responsibilities middot Manage and maintains electronic and paper archives for Regulatory submissions, submission documents, and related correspondence for multiple Regulatory Applications (INDs, BLAs, etc.) middot With some guidance, maintain and ensure Regulatory information is accurate in Regulatory systems. middot Scan paper documents into PDF format, OCRrsquos the PDFs, and upload the PDFs into the Regulatory Document Management System (DMS). middot Support archive projects such as migrating previously scanned paper submissions, legacy documents, and archive index information into the Regulatory DMS. middot Collaborate with the RIM Process team and key stakeholders. middot Communicate key RIM-related information to consumers, collect feedback, and take action. middot Work to ensure regulatory data is compliant with defined standards, policies and quality requirements middot Assist with user training. middot Assist with managing paper archives. middot Assist with managing RIM knowledge objects. middot Identify and communicate regulatory system enhancement needs or technical issues. middot 2 -5 years of relevant regulatory information management experience with applicable Regulatory Agency regulations, guidelines, andor specifications (e.g., FDA, EMA, ICH) and drug development process. middot Bachelorrsquos degree in a related field. middot Knowledge of pharmaceutical drug and device development process. middot Knowledge of categorization and classifying information. middot Ability to contribute to improvement initiatives middot Experience in Regulatory AffairsOperationsinformation preferred. middot Knowledge and practical experience in global submissions and principles of information systems preferred. middot Knowledge of scientific industry terminology and how to effectively use as metadata preferred. middot Knowledge of relationships between key components of Regulatory Information preferred. middot Ability to manage, andor contribute to multiple ongoing projects simultaneously middot Knowledge of technical writing is preferred middot Knowledge of 21 CFR Part and Annex 11 Regulations is preferred middot Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills. middot Possess energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills.

Keywords: Hallmark Global Technologies, Yonkers , REMOTE Regulatory Information Management Archives Consultant, Other , Yonkers, New York

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