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Translation and Artwork Manager

2 months ago

London, Greater London, United Kingdom Novartis Full time
About the Role

We are seeking a highly skilled Translation and Artwork Manager to join our team at Novartis. As a key member of our Development Team, you will play a critical role in ensuring the availability and implementation of high-quality, regulatory-compliant translations and artwork of key product information documents.

Key Responsibilities
  • Manage a quality-focused and compliant translation process for key product information texts, ensuring timely completion of translation requests and quality control of incoming translations.
  • Advise colleagues on regulatory and planning requirements, and liaise with EU RA Country Organisation and GPRM/GPRL colleagues on points of procedure and language issues.
  • Submit completed translations to EMA with supportive documentation, and release final approved files to implementation in the EU market.
  • Be independently responsible for training new translation and translation & artwork team members in CP and LS processes, sharing best practice as an expert in all aspects of CP for product information and artwork.
  • Proactively propose and negotiate with the EMA on complex regulatory procedures, working with EU RA and operational leads to manage responses from the authorities to reach agreement on final versions for submission.
Requirements
  • Bachelor's degree in one or more modern languages.
  • Excellent command of written and spoken English, as well as at least two other EU languages.
  • Prior experience in a translation and artwork role, with good knowledge of CP, EME Guidelines, artwork and related business processes.
  • Excellent working knowledge of regulatory affairs, the translation and artwork process.
Why Novartis

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that our employees are our greatest asset, and we strive to create a workplace that is inspiring, challenging, and rewarding.