Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
The Role:
This role offers hybrid working, requiring 3 days per week in our White City, London office.
As the Translation and Artwork Manager you will be responsible ensuring the availability and implementation of high-quality, regulatory-compliant translations and artwork of key product information documents, in 24 languages and to EMA deadlines. This activity is to support EU approvals via the centralised procedure (CP).
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You will also share your regulatory, linguistic and artwork expertise and strategic advice to colleagues in RA and other line functions, participating in related RA, company and inter-company projects.
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
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
United Kingdom
Site
London (The Westworks)
Company / Legal Entity
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No