193 days ago on nemensis.force.com

Labeling Specialist (m/f)

nemensis ag

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Labeling Specialist (m/f)

Our client is a global operating biopharmaceutical company. For its site located in the Basel area we are looking for a
Labeling Specialist (m/f)
This is a temporary position for at least 1 year
Job Responsibilities

  • Managing the translation of EU Annexes within the framework of labeling variations or original MAA
  • Coordinating translations of CTA relevant documents
  • Review and adapt processes to changing requirements in Global Labeling
  • Maintains a database of translators, including an appraisal procedure for evaluating translation agencies and individual translators along professional lines
  • Ensure compliance with internal policies on labeling.
  • Maintains a database of world-wide approved labels
  • Managing effective working relationships with stakeholder departments and affiliates within the company
  • Keeping close contact to DRA, Clinical Science, IT and other departments
  • Ensure harmonized worldwide safety labeling through a common Core Safety Data Sheet (CSDS).
  • Interact with local DRA worldwide to ensure timely implementation of global safety labeling changes of CSDS
  Candidate Requirements
  • 2-3 years of labeling experience in an international set up
  • Strong experience in working with labeling text, packaging, leaflets and product information
  • First experience with variations and some knowledge about the whole Regulatory Afffairs chain is a major advantage
  • High attention to details
  • Very good communication and coordination skills
  • Strong team player
  • Fluency in English both oral and written
To apply for this position, please use the application button below.
If you have further questions ,Mrs. Dr. Waltraud Bueb (waltraud.bueb@nemensis.com), Managing Director will be happy to assist for this position.
To ensure a speedy processing of your application, we would like to ask to send us your complete application documents (CV, job references, certificates, diplomas).
nemensis ag
+41 61 205 98 98