Summary
About the Role
Major accountabilities:
As a Translation Manager, you will be responsible for:
Managing a quality focused and compliant translation process for key product information texts, approx. 70+ products for EU CP approval.
Advising colleagues on regulatory and planning requirements, timely completion of translation requests and QC of all incoming translations. Liaise with EU RA Country Organisation and Global Program Regulatory Manager (GPRM) / Global Labelling Manager (GLM) colleagues on points of procedure and any language issues that arise, addressing HA language reviewer feedback as required.
Supporting submission of completed translations to EMA with supportive documentation and once approved, release of final approved files for implementation in the EU market.
Supporting, for assigned projects, Language Services linguistic review and compliance of formatting to EMA requirements.
Supporting teams in proactively proposing and negotiating 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.
Ensuring the linguistic quality of English product information texts, performing thorough review of all text versions to ensure appropriate linguistic style and quality and compliance of formatting and terminology with EMA requirements.
Your experience:
Bachelor’s degree in one or more modern languages. A specific translation qualification is desirable.
Excellent command of written and spoken English, as well as at least two other EU languages.
Prior experience in a translation role, with good knowledge of CP, EMA Guidelines, and related business processes.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
