Job Description: The detail-oriented Submission Specialist is responsible for all paper and electronic publishing activities for regulatory submissions to global health authorities following FDA and ICH guidance Job Responsibilities: Participate in draft and final document reviews with a focus on managing quality control of document preparation of Word and PDF documents to health authorities Proofread, review and edit Word documents for grammar, accuracy, and consistency Prepare submission ready documents that includes bookmarking and hyperlinking Overall operational planning, coordination and support of compliant submission dossier publishing activities with the ability to manage publishing timelines for the compilation of submission and maintenance of regulatory filings Coordinate document deliverables and submission timelines with publishing vendor Plan, prepare and publish submission documents (IND's, CTAs, Amendments, DSURs, IMPDs, SUSARS, etc.) for both electronic and pap
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