Company: SEC Recruitment
Closing Date: 19 Dec 16
Salary (£): 60,000 - 80,000
Regulatory Electronic Submissions Publisher (ESP)Brussels, BelgiumWe have a challenging, business critical positions available to work for a leading, global pharmaceutical company on a 12 month contract basis in Brussels, Belgium. There is excellent potential for extension for high performers. ...
Regulatory Electronic Submissions Publisher (ESP)
We have a challenging, business critical positions available to work for a leading, global pharmaceutical company on a 12 month contract basis in Brussels, Belgium. There is excellent potential for extension for high performers.
Role and responsibilities:
• The ESP will work within the European Regulatory Operations team in Brussels and take responsibility for the preparation of the electronic version of the regulatory filings needed to obtain and maintain marketing authorisation for the company’s medicinal products.
• You will work with the documents and dossiers required for publishing for the eCTD and organise them for regulatory filings in Europe, in accordance with the relevant EU and Global standards
• You will publish the documents (PDFs) with relevant navigations tools, expedite finalisation of the submissions, ensure quality of work, proactively identify and resolve issues and continuously implement process optimisation.
• You will work in close collaboration Global Regulatory Operations dept. to maintain the work processes that support the submission assembly, monitor regulatory changes in Europe and provide operational support for the filing of regulatory dossiers through assembly, finishing, printing and distribution of the dossiers.
Requires skills and qualifications:
• Good experience in publishing with Liquent Insight Publisher (or a very similar package)
• Strong customer service and analytical skills and able to communicate effectively with all levels
• Excellent written and oral communication skills are required
• Able to work to tight deadlines (which can change)
• IT knowledge: working knowledge of the standard computer applications – preferably will have good skills/knowledge of MS Office, Adobe Acrobat, MS Project and Documentum)
• Demonstrable proactive approach to work
• Able to collaborate effectively in a multi-cultural working environment
• Must be able to speak and write English fluently (no other language skills are required)
This is a fantastic opportunity to work for a leading, global pharmaceutical company in a multi-cultural environment, where there are ever-changing challenges to undertake. This position is essential for the business and you will play a key role in their success.
To apply for this position and put yourself under immediate consideration, send your CV to email@example.com or call +44 (0) 207 255 6600
3rd Floor, 13-15 Moorgate London.
|Tel:||00 44 (0) 207 255 6600|
|Fax:||00 44 (0) 1483 888997|
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