Clinical Publisher Associate

French Clinical Trial Start up Associate
October 6, 2021
Regulatory Associate
October 6, 2021

Clinical Publisher Associate

  • Permanent
  • Cork
  • Posted 2 weeks ago

Purcelloleary Recruitment

Pharmaceutical

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.

Job requirements:

  • 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.

 

Job requirements:

  • Degree qualified in a related field
  • Three years’ experience publishing submissions using eCTDXpress.

 

 

 

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