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Advanced Resource Managers are currently searching for a Junior Labelling Specialist for our client based in central Munich. They are a leading mid-sized Pharmaceutical company focusing in advanced drug delivery technologies.
You will be involved with the following responsibilities within the role –
· Manage the labeling review and approval processes.
· Support the creation and maintenance of regulatory compliant documents.
· Working closely with the Medical Affairs team to provide medical relevance assessment and labeling guidance.
· Conducting Text comparison (originator, reference vs generic)
· Documenting and monitoring of all global and local changes for the assigned portfolio of brands/products
· Contribute to labeling process improvement initiatives
Skills/Experience needed -
· Degree qualified
· 0-2 labeling experience within the Pharma industry or experience in Regulatory
- Understanding of labeling changes
· Solid knowledge of labeling guidelines and regulations
· Experience in documentation and archiving
· Experience with with docuBridge and drugTrack is an advantage.
· Team player with good communication skills
· Excellent written and verbal communication and interpersonal skills. Fluent in German & English (written and oral) is a must; any further languages are an advantage
This role will be joining new Labeling team based in Munich who have a flat organisation structure therefore there are good progression opportunities within the team and business. The position is compensating €80,000 - €90,000 plus 10% bonus an benefits.
If you are interested in this opportunity please contact Vik Patel at ARM on 00442392
458031 or email me on email@example.com
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