※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
The Companion Diagnostics (CDx) Project Manager-Japan will be responsible for implementing the Japan CDx related activities within the defined timeframe and budget. The CDx Project Manager-Japan will support the interactions between the external Diagnostic Partners in Japan and the internal stakeholders in partnership with the Global CDx Leader and CDx sub team to accomplish the Japan-specific CDx related activities.
- In alignment with Global CDx strategy, creating and executing CDx project work plans including regulatory communications with local Diagnostic partner and internal stakeholders, and modifying as appropriate with Japan specific concerns to meet changing needs and requirements
- Tracking project scope, costs, expenses, budgets against defined metrics for Japan in active alignment with Global CDx Lead and key functional stakeholders
- Providing complete tracking of all project phases and activities in Japan - communication of timelines, and milestones
- Organizing east CDx sub team with providing the agenda discussing with Global CDx lead, reporting the meeting minutes to Global CDx sub team
- Ensuring that project documents are complete, current, and available to CDx Sub team and relevant Clinical and regulatory teams in Japan
- Communicating issues and minimizing risks as well as creating associated mitigation strategies for Japan-related CDx projects
- Candidate will have a degree in biological sciences or a related discipline. A BS or MS degree with 7+ years of relevant experience managing complex development projects required or a PhD with 3+ years of work experience in pharmaceutical/diagnostics setting required.
- Experience in Companion Diagnostics strongly preferred.
- Completion of Project Management Training is a plus.
- Demonstrated track record of success working on a multidisciplinary pharma/diagnostic development team.
- Knowledge of design control, market and product requirements management, and the IVD development process is a plus.
- Knowledge of molecular diagnostics technology, competitors, and market space is preferred.
- Established expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, SharePoint and remote meeting tools such as WebEx, Live Meeting
- Expert planning and tracking skills, with the ability to capture details and summarize in an integrated cross-functional plan
- Well- organized, focused on results, capable of managing multiple projects, excellent time management skills.
- Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
- Solid interpersonal and verbal and written communication skills
※Experiences and skills will be considered
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