TLAC Medical AssociateJuly 29, 2021
Clinical Publisher Associate
Purcelloleary Recruitment are looking to recruit a Clinical Publisher Associate for a pharmaceutical company in Co. Cork. This is a REMOTE position for the foreseeable future; however, the successful candidate must be able to be onsite in Cork in the future. This is an exciting opportunity for a driven individual.
- Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
- 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, and LillyNet [SharePoint]) to ensure compliance. Stay up to date on system and tool upgrades.
- Degree qualified in a related field
- Three years’ experience publishing submissions using eCTDXpress.