RA Labeling Coordinator

Bedrijfsnaam: -
Plaatsingsdatum: 02/05/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.The CompanyJanssen Vaccines is committed to developing first-in-class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff, 45% of our employees has a nationality other than Dutch with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.

In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen Vaccines.

Role DescriptionRA Labelling Coordinator with cross-regional scope of work. Support LOCs in submitting compliant local labels in time by quality check of labelling documents in EMEA and Asia Pacific.

ResponsibilitiesMain duties and responsibilities:
• Maintain oversight of compliant labels for EMEA.
• Ensure updates are integrated into the latest available local label in a compliant manner
• Archive/store the local label in English and local language in a central repository
• Initiate content deviation process, if required
• Ensure updates are integrated into artwork in a compliant manner

RequirementsEducation and experience
• 5 or more years of regulatory experience, labelling experience preferred
• University degree or equivalent by experience
• Previous experience in RA role as Associate, Professional or similar role is of advantage
• Able to influence without authority - experience in a matrix structure
• Able to make independent decisions
• Experience of working in a virtual team and/or global organization
• Multitasking, accurate and conscientious
• Knowledge of regulatory IT systems (especially document management and planning)
• Language capabilities: fluent in English, generic feel for languages

• Concern for Quality and Order
• Information seeking
• Personal Motivation
• Detail-orientation combined with being able to take a step back (helicopter view)
• Analytical skills and technical RA knowledge (ability to assess Impact of Label change on current situation)
• Communication skills and cultural sensitivity in working with stakeholders across countries
• Proficient in English (incl technical RA English)
• Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient

Other informationFull time applicants only. Full year resource approval given, in case of strong performance it is expected further extension could be possible, but no guarantees can be given. We're looking for an individual who is precise, accurate and detail oriented, and able to change priorities as needed. Will be working largely virtually so can work completely remote / from home. Good English needed and a sensitivity to other European colleagues.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
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