USDM Life Sciences

About USDM Life Sciences

USDM Life Sciences Overview USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our customers that are in the business of saving lives. It’s a place where you can make an impact in the world as a champion for life sciences innovation and also get the experience and mentoring to grow your career. Founded in Santa Barbara, California in 1999 by two UCSB graduates, USDM has grown to a global company with offices throughout the US, Toronto, Canada and Frankfurt, Germany. Job Description USDM is looking for a strong Senior Consultant to join our team. Responsibilities will include: Guide the client's records management and eCTD strategy. Support various stages of eCTD functions of building, viewing, validating and publishing (electronic or paper) and enable the easy-to-use compliation of compliant electronic dosiers based on CTD, eCTD and other applicable dossier structure. Define technical requirements down to component level (individual documents) and map it to controlled document source (ComplianceQuest, box etc.) Qualifications Experience working with submission management system to support various stages of eCTD functions of building, viewing, validating and publishing (electronic or paper) and enable the easy-to-use compilation of compliant electronic dosiers based on CTD, eCTD and other applicable dossier structure. Ability to help define requirements for eCTD submission based on NDA/MAA. Experience of defining technical requirements down to component level (individual documents) and map it to controlled document source (ComplianceQuest, box etc.) Experience working with submission tools like Extedo, datafam, Liquent, Lorenz, MedXView etc. Experience implementing submission management system. Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. USDM Life Sciences is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran, disabled, or any other protected status.

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Company Type: Private

Company Size: 251 - 500

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