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Regulatory Document Translator

Novartis
Shanghai, 上海市
全职
3天前

Summary

To ensure regulatory documents are translated (English/Chinese) efficiently, costeffectively, and to a high level of quality.

About the Role

Key responsibilities:

  • Translation:

a. Translate various types of documents (English/Chinese) including but not
limited to Informed Consent Forms (ICFs), Clinical Study Reports
(CSRs), Risk Management Plans (RMPs) and Periodic Safety Update Reports
(PSURs),
b. Conduct post-translation formatting as per specified requirements,
c. Support urgent translation requests for specific regulatory documents
(such as urgent drug safety report and data inspection questions) out of
office hours,
d. Respond in a timely and professional manner to any query concerning
translation.

  • Quality check:

a. Perform quality check on peer translated documents,
b. Provide feedback for preliminary translation (e.g. QC summary).

  • Continuous improvement:

a. Update translation glossary/memory databases,
b. Participate in or plan routine team meetings to discuss work-related issues
and possible improvements (e.g. knowledge sharing),
c. Embrace new technologies (e.g. machine translation) and changes in this
industry to improve translation skillset continuously.

  • Project management and daily operation:

a. Oversee translation request coordination, and process management,
b. Manage project and team finances and resource planning, including
budgeting,
c. Compile translation metrics,
d. Organize trainings for internal and external stakeholders,
e. As representative of RWS team, support development and maintenance
of working tools and systems, e.g. Trados, NovStyle, machine translation
and so on,
f. Perform other special activities or duties when required.

Essential requirements:

  • Bachelor’s or Master’s degree in Life Sciences/English/Translation
  • High level of proficiency in written English and Chinese
  • Around 2 years of translation/writing related experience in the pharmaceutical/healthcare industry.
  • Basic knowledge in medical science/bioscience/pharmaceuticals is required.
  • Familiar with SDL Trados and MS Office.

Desirable requirements:

  • A good team player with excellent communication skills.
  • Ability to prioritize tasks and deliver high-quality translation within tight timelines.
  • Ability to understand, interpret, and translate clinical and scientifi documents.
  • Strong ownership, detail-oriented and strong sense of responsibility.

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
China
Site
Shanghai (Shanghai)
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.
Alternative Location 1
Beijing (Beijing), China
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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