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Publishing Specialist

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.03.04.
Jelentkezési határidő: 2015.04.27.
Hirdetés azonosító: 912282


Publishing Specialist
A Publishing Specialist position is open at our regulatory team of a prestigious multinational company based in Budapest. The main aim of the publishing specialist role is to support and provide coordination, compilation and publishing expertise in the preparation of new and existing regulatory applications including initial applications, amendments, supplements, variations and other submissions in compliance with health authority regulations

The main responsibilities of the Publishing Specialist role are:

• Lead and coordinate the compilation of paper submissions and assembly of electronic submissions
• Perform publishing activities using various electronic technologies including electronic publishing
• Bookmark and hyperlink PDF documents to ensure adherence to ICH guidelines for incorporation into eCTD submissions using PDF editing tools including Adobe Acrobat and ISI Toolbox
• Liaise with regulatory product managers, concerned functions and external Business Partners organizations when applicable; facilitate communication and collaboration to meet submission timelines and plan future work.
• Perform occasional report publishing in collaboration with authors across functions
• Coordinate EU Annexes translations with Product Managers, EU Affiliates and other functions and ensure adherence to EMEA/QRD requirements
• Communicate and advise product teams / individuals on RSG publishing requirements
• Mentor / train junior RSG members & new hires in publishing processes and standards and conduct group training sessions when necessary.
• Assist in assuring adherence to current publishing processes and standards and support development of new publishing standards and processes
• Contribute to the improvement of submission processes and working practices through working groups, submission debrief meetings.
• Write / update submission guidelines and SOPs, as well as conduct user training
• Assist technical teams to develop, validate and implement electronic processes and procedures

The core requirements of the publishing specialist position are:

• Good computing skills – extensive experience in MS Word, Excel, eCTD requirement, lifecycle management, Adobe Acrobat & ISI Toolbox and Compose
• Minimum of 3 years relevant experience in the pharmaceutical industry
• Advanced regulatory publishing experience
• Job knowledge - possesses working knowledge of document management and publishing software and supporting tools
• 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
• Interpersonal & Teamwork Skills - works effectively as a team member in matrix-based environment to produce high quality output while meeting aggressive timelines.
• Planning and organization - independently organizes and prioritizes activities; demonstrates the ability to work under pressure and efficiently deal with multiple assignments
• Analytical skills & problem solving – solves basic problems and applies experience in solving problems of a similar nature

If you are interested please do not hesitate to upload your English CV.

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