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Documentation Coordinator

Company: TSR Consulting Services, Inc.
Location: New Brunswick
Posted on: June 30, 2019

Job Description:

Title CMC DOCUMENT SPECIALIST Location New Brunswick, NJ Industry Pharmaceuticals Job Description The primary role is to support the regulatory activities for pre and post submissions for biologic products as part of the CMC Strategies team. The CMC documentation group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration. Support the logistical process for regulatory submissions including pre and post submissions while interfacing across the client network. Assist with dossier creation and system compliance for regulatory submissions. Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings. Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. Participation on various cross-functional project teams, interactions with MST, TPT, IDT, SLT and GRS-CMC staff at different client sites and other key partners both internal and external to the company are necessary. Must possess the ability to support multiple projects and to prioritize work independently. Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers. Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines. Requirements and Education BS degree required. 1-2 years of direct pharmaceutical work experience preferred. Advanced degree in regulatory is an asset. Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems. Must demonstrate an understanding of the global CMC regulatory guidelines, practices and applications. Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication. Must have a working knowledge of regulatory submissions for pre and post filings. Ability to successfully collaborate with a diverse group of technical professionals and interpersonal styles is required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process. Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions. If Interested, please send your updated resume to dpateltsrconsulting.com mailtodpateltsrconsulting.com and reach out to me at 732-321-9000 ext. 4247 ASAP, thanks.

Keywords: TSR Consulting Services, Inc., New Brunswick , Documentation Coordinator, Other , New Brunswick, New Jersey

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