Translation and Artwork/Labeling Manager

Translation and Artwork/Labeling Manager

The Translation and Artwork/Labeling Manager is responsible for ensuring the availability of high-quality, regulatory-compliant translations of key product information documents required for EU approvals into 24 languages within tight EMA timelines and for facilitating the rapid and correct implementation of these texts on the EU market. The Translation and Artwork Manager additionally provides regulatory and linguistic expertise to colleagues in RA. Further, the Translation and Artwork Manager acts as RA expert with regard to EU artwork strategy for products approved via the Centralized Procedure.

Accountability

Manages the translation process required to ensure timely availability of high-quality, regulatory-compliant translations of key product information texts (e.g. prescribing information, patient leaflet, artwork) for products approved in the EU via the centralized procedure (CP; 70+ products). The process requires linguistic and regulatory expertise to ensure compliance with EMA and national HA requirements and includes: issuing translation requests with detailed instructions; performing thorough QC of all incoming translations; liaising with translators on points of procedure and language; submitting completed translations to EMA and national HA reviewers and acting as point of contact to manage and ensure implementation of their feedback; releasing final approved files for implementation on EU market.

• For products under own responsibility, is responsible for ensuring LS linguistic review of the English product information texts and compliance of formatting with EMA requirements.
• For products under own responsibility, contributes to ongoing and comprehensive exchange of information among translation managers.
• Has expert knowledge of all aspects of the Centralized Procedure relating to product information; actively shares this knowledge and provides comprehensive advice and support to colleagues in RA to ensure appropriate planning and manage expectations for products under own responsibility. In the case of complex regulatory procedures, proactively proposes the approach to be taken in order to ensure maximum efficiency.
• As RA expert on CP artwork, participates in EU project strategy discussions and advises RA colleagues and other line functions (AwOps, Marketing, Supply Chain, etc.) on EMA requirements and Novartis practices regarding CP artwork.
• Is responsible for ordering, reviewing and signing off new and updated CP artwork mock-ups for inclusion in regulatory submissions and for ordering and submitting to EMA artwork specimens for launches and license renewals.
• Working with GPRM and AwOps, leads preparation of responses to EMA comments on submitted mock-ups and specimens and negotiates with EMA to reach agreement on final versions.

Role KPI

• Demonstrates operational excellence, teamwork and customer focus.
• Able to work in cross-functional, matrix teams to realize business results.
• Able and willing to make decisions independently, with managerial support as needed.
• Demonstrates excellent communication skills when interacting with teams within and outside of RA.
• Demonstrates thorough knowledge of linguistic, artwork and regulatory requirements relating to the Centralized Procedure.
• Able to understand cross-functional business needs.
• Demonstrates very high level of attention to detail. Effective problem-solving ability to troubleshoot issues.
• Demonstrates superior quality and compliance mindset.

Education / Language / Experience

Education: Minimum of Bachelor’s degree in one or more modern languages required. Specific translation qualification desirable.

Languages: Excellent command of written and spoken English. Excellent knowledge of at least two other EU languages. 1 of the 4 roles, Spanish is required.

Experience

• Prior experience as translator/translation manager.

• Knowledge of Centralized Procedure, EMA guidelines and requirements, labeling, and related business processes.

• Working knowledge of Regulatory Affairs.

• Excellent understanding of the translation process.

• Excellent understanding of the artwork/labeling process.

• Excellent verbal and written communication skills