Clinical Publisher Associate
3 days ago
**LOCATION: CORK, IRELAND (funded relocation package)**
**Primary Responsibilities**:
- Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
- 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.
- Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission.
- Coordinate with RACMC Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct.
- Educate and influence cross-functional DCoE, Sci Com, and Labelling consultants on submission requirements for CRFs, datasets, literature references, and labelling, to ensure alignment and reduce potential technical issues impacting submission timelines.
- Lead the coordination with other publishing centers and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy.
- Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.
- 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.
- Serve as a single point of contact for customers (e.g., Regulatory Associates, Regulatory Scientists, authors, cross functional stakeholders) for managing the submissions in eCTDXpress backbone.
**Minimum Qualification Requirements**:
- Degree qualified in a related field
- Two to Three years’ experience publishing submissions using eCTDXpress.
- High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
- Proficiency in SharePoint technology.
**Other Information**:
- This position is office-based work
**Job Types**: Full-time, Permanent
**Salary**: £35,000.00-£50,000.00 per year
Additional pay:
- Yearly bonus
Schedule:
- Monday to Friday
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