| Publishing Project Coordinator |
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| Category: |
Arts/Entertainment/Publishing |
| Position is: |
Full-Time |
| Location: |
North Little Rock, AR |
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| Apply: |
Click here to submit your resume ... |
| Description: |
Publishing Activities
• According to a Submission Request Form, ensures delivery of/delivers quality and timely published output
• Creation of binders in electronic Document Management System (eDMS) for all submissions under his/her responsibility.
• Publishing or publishing coordination of regulatory dossiers (paper and electronic) in consultation with functional area representatives and key stakeholders.
• Quality control of the published output or interacts with the Service Provider(s) to ensure all publishing steps are performed (e.g., Quality Control (QC) steps of publishing performed by Service Provider).
• Delivery of dossiers that fulfil Competent Authorities requirements and pass internal quality and formal validation checks.
• Delivery of published output to GRA or LRAs or Service Provider(s).
• Submission of dossiers through agency portals (e.g. FDA ESG or EMA gateway), if not handled by RA stakeholders.
• Provides intelligence to ensure that Ipsen electronic and non-electronic submissions meet current regulatory requirements pertaining to format, and adapts to evolution of those.
• Develops technical expertise in conjunction with publishing system owner in regulatory electronic submissions to meet EU, FDA and ICH current and evolving requirements.
• Ensures that processes required for regulatory information compliance, including storage and archiving, are implemented.
• Contributes to the improvement of publishing process in performing pilot tests in line with RA community.
• Maintains the planning of publishing.
• Interacts with the Service Provider(s) to ensure resources are available to complete own publishing in line with planning.
• Enter Dispatch and/or submission date and change the object status in the Regulatory tracking system according to the type of procedure and the process.
• Acts as a document specialist for Regulatory Affairs, ensuring assigned documents are "Ready for Submission".
• Ensures assigned documents are completed with high quality; planning, implementation, coordination and delivery of ready for submission (RFS) documents within agreed timelines in conjunction with the authors and contributors.
• Ensures the full use of the electronic Document Management System (eDMS) and other tools in ensuring RFS status of documents intended for submission, within assigned programs.
• Assists the Regulatory Data & Publishing Manager in testing and quality validation of in-house publishing systems.
• Assists the regulatory system owners with their system enhancement projects.
• Propose improvements to the regulatory tracking system based on daily use.
• Contributes to regulatory Intelligence initiatives, especially with regard to Publishing technical matters. This may be done through membership of societies and organisations of interest to the company.
• Interacts with the Service Provider(s) to ensure consistency in knowledge.
• Communicates and responds to queries on technical Publishing intelligence from the wider GRA community or functional authors.
Experience & Qualifications
At least 5 year-experience in dossier publishing using state of the art electronic tools.
Experience in publishing US, Canada and rest of the world.
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Click here to submit your resume ... |
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