Sr. Associate, Clinical Publisher

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Job Description: Job Summary: We are currently seeking a Sr. Associate, Clinical Publisher in Edison, NJ. This position will develop new processes for clinical document publishing and working standards, troubleshoot and repair documents, provide guidance to the Templates Working Group regarding document formatting issues. Train Medical Writers on document formatting issues, corrective actions and standards of practice. Integrates and applies strong knowledge of US electronic regulatory submission requirements in support of ongoing drug development programs. Responsible for independently formatting and publishing to PDF output electronic documents in a Ready For Submission (RFS) format. This position will collaborate with other functional stakeholders (e.g., IT, Regulatory Operations, Content Management) along with assigned Medical Writers to develop and improve cross-functional processes related to document publishing. This position has knowledge of clinical development processes, GCP/ICH guidelines, SOP/SOI development, and eCTD submissions, and experience working in a matrix organization. Responsibilities: Acts as a central resource on all Medical Writing Clinical Publishing issues to ensure consistency within documents prepared by Medical Writing or external partners; Ensures clinical documents adhere to global standards and that are in accordance with electronic publishing standards Develops new processes for clinical publishing working standards; Works to improve current processes. Establishes cross-functional relationships and processes (works with IT, Content Management, Regulatory Operations, etc.); Makes recommendations on new processes Serves as expert regarding the master template and add-in toolbar that defines proper formatting for all document templates; Advises and provides high-level guidance to the Template Working Group regarding formatting issues as needed Serves as liaison between Medical Writing and other stakeholders (e.g., IT, Content Management, Regulatory Operations) Independently formats and publishes electronic documents and ensures quality, accuracy, and submission readiness per Regulatory agency guidance and specifications. Develops and maintains document formatting and publishing procedures and standards for RFS documents required for regulatory submissions. Assists with training clinical publishing staff and MWs when relevant, on procedures and standards Provides guidance to multidisciplinary teams on format, style, and architecture of electronic compliant documents for INDs, NDAs, BLAs, MAAs, CTAs, annual reports, amendments, supplements, or variations in accordance with title 21 CFR and all FDA, EU and ICH guidelines. Provides recommendation for formatting standards and granularity of ready for submission documents and contributes to the creation and management of templates and associated training materials e.g. quick reference guides etc. May manage direct reports and/or mentor colleagues. Education/Experience Minimum 5-7 years’ experience Bachelor's Degree, Associate’s Degree, or equivalent experience; Word certification preferred Submission experience required Some experience in clinical development Previous experience in document management system (FirstDoc preferred) Advanced proficiency in use of Microsoft Word and Adobe Acrobat are required. Advanced knowledge of SharePoint, Starting Point and ISI Toolbox. Excellent communication and interpersonal skills and the ability to manage priorities and work under tight timelines. Excellent organization skills and sound attention to detail Works independently; strong technical, organizational, and communication skills; strategic and critical thinking; specialized expertise in formatting and publishing documents Daiichi Sankyo, Inc. is an Equal Opportunity Employer - M/F/D/V
Phama Job Categories: 
Research and Development

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