- 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.
- 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
- Deep understanding of industry regulations and guidance
- Strong project management skills
- Ability to collaborate and negotiate within a cross-functional team environment
CDS is a leader in executive search and recruiting services in Japan. We are a close and trusted partner of multinational corporations and start-up companies on search assignments for board members, country managers, and senior to mid-level management roles. CDS is part of RGF – the global arm of Recruit, Japan’s largest recruiting group – giving us wider client coverage and greater candidate access throughout Asia.
CDS was founded in Japan in 1998 and is headquartered in Tokyo. Our operations include a branch office in Osaka and a strong partnership network across Asia.
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