Bespoke Recruitment B

Clinical Publisher Associate - eCTD (BB-9C68F)

Found in: Xpatjobs IE

Primary Responsibilities:Functional and Technical Expertise * * Demonstrate in-depth understanding of ICH CTD format/style requirements and evolving US/OUS agency standards/trends. Apply knowledge to manage a variety of complex submissions * Provide publishing to influence strategies of upstream contributors/vendors to enable successful implementation with minimal impact to resources and supply chain. * Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labeling to deliver the submission. * Understand, log, and manage Incoming Correspondence from and all Records of Contact with the FDA to enable rapid and accurate updates to RAPT and RCTT impacting project timelines and pending approvals. * Accountable as process owner of a specific process. (e.g., ROCs/IC, RAPT eFiles, Publisher Qualification, CRF/CRT, OUS Submissions, etc.) to technically evaluate, drive improvements and contribute to RQS procedures. * Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway to ensure compliance. Stay up to date on system and tool upgrades. * Demonstrate in-depth understanding of complex multiple FDA forms and apply project knowledge to ensure accurate submissions. * Leverages internal and external forums to continue to develop and share regulatory and drug development expertise around electronic submission structure and content.2. Decision Making * * Make decisions based on ICH guidance and global regulations to ensure compliant submissions and to drive improvements. * Identify errors in documents from contributing authors/vendors and initiates resolution of issues/errors/discrepancies. * Use molecule/product and registration knowledge to accurately assign keywords, and accurately populate/execute complex FDA Forms.3. Influence * * Educate and influence cross-functional DCoE, Sci Com, and Labeling consultants on submission requirements for CRFs, datasets, literature references, and labeling, to ensure alignment and reduce potential technical issues impacting submission timelines. * Lead the coordination with other publishing centres and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy. * Drive improvement in SME area with registration process owner and management and incorporates changes to job aids, Publisher Qualification program, and RQS procedures. * Influence Regulatory Scientists and/or Directors to complete and sign cover letters and forms in critical timelines to ensure on time submissions. * Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.Problem Solving * * Identify gaps and define needs to optimize publishing processes/tools that meet agency preferred specifications and CRR submission work. * Identify molecule specific eCTDXpress publishing errors/issues and influence Regulatory Associates/authors/vendors/consultants to correct errors and coach to build capability for future submissions.Minimum Qualification Requirements:The following skills and abilities are directly related to the essential functions of the job. * * Degree qualified in a related field * 3 years experience publishing submissions using eCTDXpress. * Proficiency in SharePoint technology

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location_onCork , County Cork, Ireland

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