Company: SEC Recruitment
Closing Date: 09 Dec 16
Salary (£): 80,000 - 100,000
Regulatory Electronic Submission Publisher – BrusselsContract duration: 9 monthsBrussels, BelgiumThis fantastic job opportunity has arisen within one of the leading global healthcare companies providing innovative medicines, treatments and animal health products.The Electronic Submissions Publisher will work within the EMEA team in Brussels. ...
Regulatory Electronic Submission Publisher – Brussels
Contract duration: 9 months
This fantastic job opportunity has arisen within one of the leading global healthcare companies providing innovative medicines, treatments and animal health products.
The Electronic Submissions Publisher will work within the EMEA team in Brussels. The person will be responsible for preparing the electronic version of the regulatory filings required to obtain and maintain the marketing authorization of the company medicinal products.
Role and responsibilities:
Publishing Documents and Dossiers in eCTD
Organize and assemble the documents for the regulatory filings in Europe in accordance with the EU and global standards for electronic submissions, i.e. electronic Common Technical Documents (eCTD), non-eCTD Electronic Submissions (NeES); and in compliance with company standards and procedures:
• Publish the documents (PDF files) with navigation tools (bookmarks and hypertext linking)
• Expedite finalization of the submissions while maximizing the quality of work
• Proactively identify and assist in the resolution of technical issues
• Continuously identify process optimization opportunities.
• Work in collaboration with the Global Regulatory Operations department
Required skills and qualifications:
• Minimum 3 years publishing experience with Liquent Insight Publisher, knowledge of other publishing tools will be considered as beneficial
• Strong analytical and customer service skills with the ability to work with varying grade levels, educational background and departments.
• Demonstrated ability to work under tight and changing deadlines.
• Proven attention to detail and ability to work with a variety of technical applications.
• Strong knowledge of the English language
• Knowledge of the regulatory registration procedure in EU (CP, MRP/DCP national)
• Knowledge of publishing requirements in other regions will be considered as a plus
Don’t miss this fantastic opportunity to work with one of the world’s leading pharmaceutical companies.
To find out more information about this role please contact Elena on
UK +44 (0)20 7255 6665
FR +33 (0)17 080 7489
DE +49 (0)69 222 22 888
CH +41 (0)44 580 3717
or send your CV to email@example.com
3rd Floor, 13-15 Moorgate London.
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