[Innovative Medicine] Project Lead, Regulatory Medical Writing, Japan Document Management Group, IB

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:
Position Summary:

This role will play a key role in the continued transformation of the Translation Office by leveraging AI translation, translation management technology, and data-driven process improvement.

The Project Leader will contribute to advancing translation operations by identifying new opportunities, translating them into practical solutions, and leading their implementation in collaboration with cross-functional and global stakeholders.

We are looking for someone who combines strong project management capabilities with digital acumen and a continuous-improvement mindset.

The successful candidate will be comfortable exploring emerging technologies, challenging established processes, collaborating across organizational boundaries, and turning innovative ideas into sustainable business improvements.
Key Responsibilities:


* Play a key role in transforming translation processes for drug development and clinical study-related documents, identifying and implementing new ways to improve how translation work is performed.


* Drive the optimization and further development of AI-enabled translation and translation management capabilities to improve translation quality, efficiency, consistency, and scalability.


* Lead the effective utilization and enhancement of Translation Memory, terminology, feedback data, and other translation assets to continuously improve translation quality.


* Develop and implement data-driven approaches to evaluate translation quality and process performance, identify improvement opportunities, and translate findings into actions.


* Explore and implement opportunities to standardize, simplify, and automate translation and quality-control processes.


* Participate in or lead cross-functional initiatives for digital transformation, process innovation, and business improvement.


* Collaborate with global teams, technology partners, vendors, and business stakeholders to incorporate Japa...