募集要項
- 仕事内容
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- Translate/QC/Edit of documents such as BDs for PMDA consultation meetings, CTDs, and other Clinical or Regulatory documents in line with the in-house document standards.
- Participate in document timeline/resource planning within submission teams.
- Prioritize, track and forecast work, and anticipates required future resources.
- Manage and supervise the work of external translation/QC/Edit resources to in-house standards.
- Contribute to development work in relation to document standards, continuing template development, and other aspects of document development and translation/QC/editing.
- 応募資格
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- 必須
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- More than 5 years of relevant experience including clinical R&D or regulatory experience as well as direct clinical document writing, QC and editing experience
- Excellent verbal and written communication skills and interpersonal skills
- Advanced computer skills in Word, Adobe, Excel and the Regulatory Document Management System
- Knowledge regarding applicable regulatory document requirements/guidelines in Japan
- Excellent organization skills and attention to detail, along with ability to work on a number of projects with tight timelines
- 歓迎
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- Deep understanding of industry regulations and guidance
- Strong project management skills
- Ability to collaborate and negotiate within a cross-functional team environment
- 雇用形態
- Full Time
- 勤務地
- Tokyo
- 年収・給与
- 9M - 14M (depends on experience)
