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
Skills • 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.