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Publishing Specialist

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.10.14.
Jelentkezési határidő: 2015.10.27.
Hirdetés azonosító: 960281
lejárt

 

 
 
Publishing Specialist
A Publishing Specialist position is open at our regulatory team of a prestigious multinational company based in Budapest. The purpose of the Publishing Specialist role is to support authors to publish submission ready documents by applying appropriate compliance check.

The key responsibilities of the Publishing Specialist role are:

• Support and provide coordination, compilation and publishing expertise in the preparation of new and existing regulatory applications including initial applications (CTAs, INDs, MAAs, NDAs etc.), amendments, supplements, variations and other submissions in compliance with health authority regulations
• Primary focus is on regulatory submissions of moderate to high complexity both eCTD and non-eCTD format, including all Modules accountability for large submissions
• Coordinate EU Annexes translations with Product Managers, EU Affiliates and other functions and ensure adherence to EMEA/QRD requirements: provide support in the preparation of the English Annexes, initiate & coordinate translation activities
• Write / update submission guidelines and SOPs, as well as conduct user training

Requirements:

• Minimum of 3 years relevant experience in the pharmaceutical industry
• Good computing skills – extensive experience in MS Word, Excel, eCTD requirement, lifecycle management, Adobe Acrobat & ISI Toolbox and Compose
• Regulatory Knowledge - working knowledge of ICH, FDA, EU dossier structural requirements
• Commitment to quality - consistently produces work of high quality, follows procedures while meeting aggressive timelines
• Job knowledge - possesses working knowledge of document management and publishing software and supporting tools
 
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