Summary
About the Role
Major accountabilities:
You will manage a quality focused and compliant translation process for key product information texts, approx. 70+ products for EU CP approval!
You will advise colleagues on regulatory and planning requirements, timely completion of translation requests and QC all incoming translations. Liaise with EU RA Country Organisation and GPRM/GPRL colleagues on points of procedure and any language issues that arise, addressing HA language reviewer feedback as required.
You will submit completed translations to EMA with supportive documentation and once approved, release final approved files to implementation in EU market.
For personal projects, be responsible for LS linguistic review and compliance of formatting to EMA requirements.
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.
Is proactive in 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.
Your experience:
Bachelors 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 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: 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.
