Job description

Clinical Publisher Associate - Bilingual French & English

Location: Cork, Ireland - multinational pharmaceutical company

Main responsabilities:

• Serve as an electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
• Demonstrate an 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 on resources and the 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 a 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 [SharePoint]) 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.

Main requirements:

• Degree qualified in a related field
• experience publishing submissions using eCTDXpress.
• Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and customers.
• Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability
• High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
• Proficiency in SharePoint technology
• Proficiency in FRENCH is an advantage

Other Information/Additional Preferences:

• This position reports functionally to a CRR Manager.
• This position is office-based work.
• The shift for the position is Monday through Friday, 8 hours a day.
• Some overtime may be required.

Job Types: Full-time, Permanent

Salary: €30,000.00-€45,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Reference ID: D.B.

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