Application Specialist ・ MI， Japan / 社名非公開
|職種||Application Specialist ・ MI， Japan|
Application Specialist ・ MI， Japan， is primarily responsible for MI(Molecular Imaging 核医学)， providing clinical application， product support and training to the assigned customers in Japan. The objective is to provide application and clinical support to the assigned customers and sales team to achieve targeted sales and profit objectives， in accordance with the Country/Regional/Segment Business Plan.
Key responsibilities include (but are not limited to):
・ Provide application， clinical and product training to assigned customers and sales team.
・ Provide insight to sales team for effective planning and strategy on sales
・ Develop sales tools to enhance sales team competency
・ Improve customer satisfaction through continuing education on optimization of equipment utilization by customer
・ Escalate innovation needs and customer feedback on products to Make Center to improve product quality / performance and meet customer expectation
・ Drive business growth by providing customer support and education
・ Maintain key opinion leader engagement by providing application support and regular visit.
・ Provide high level and effective pre-sales demonstration on Workstation features including potential usage， product capabilities and benefits to customers.
・ Support tradeshows and clinical seminars/workshops by performing product presentation ＆ demonstration.
・ Maintain an awareness of competitor activities and developments and ensure that this information is collected
・ Produce well-written pre ＆ post-installation reports and provide regular feedback on customer satisfaction and needs
・ Bachelor’s Degree
・ Minimum of 5 years commercial applications/modality experience with demonstrated successes in high level customer interactions and sales scenarios is required
・ Experience with MI would be an advantage
・ presentation skills (public speaking and lecture experience desired)
・ communication skills to effectively communicate to external customers， global counterparts and to team members in other functional organizations)
・ Willingness and ability to travel extensively within the specified geographic region
・ Team oriented with a customer satisfaction mindset
・ Qualified Radiological Technologist (診療放射線技師資格)
・ Fluent in Japanese
・ Demonstrated ability to understand and present complex material in understandable terms
・ Solid problem solving skills (ability to manage and resolve conflict， communicate issues and propose solutions to both internal team members and external customers)
・ Proven professional business acumen (experience interfacing with both internal team members and external customers as a part of a solution-based sales process)
・ Ability to multi-task effectively and manage multiple priorities at one time
・ Self-motivated， willingness to take the initiative to identify opportunities for improvement and take actions to constantly update on new clinical applications and technologies.
・ Willingness to be flexible/adapt to changing work environments
・ Fluent in English
|年収||600万円 - 1200万円|
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1.Maintenance -Ensure equipment functionality and reliability. Maintain all production equipment， facilities and utilities in an effective operating and compliant state. -Equipment qualification， documentation and change control. Ensure that changes to equipment and systems are carried out， qualified， and documented according to approved change control procedures. 2.Engineering -Planning for Engineering Project aligned with quality ＆ EHS requirements and with the local and global strategy. -Engineering compliance， to provide necessary guidance to ensure compliance with all applicable external and internal regulations and requirement regarding quality and EHS. -Manage engineering budget， run an efficient and effective engineering activity through managing the engineering site budget and resources. 3.People ＆ Organization -Lead a professional engineering team， by identify， develop and retain qualified people to provide engineering and maintenance services. -An influential functional expert within the site management team. Influence decision making and take an active role in promoting cross-site initiatives， collaboration across site’s functions. -Implement global best practices and actively share knowledge and lesson learned to contribute and support a high professional level of engineering globally.
＜Job Description＞ Ensuring the analysis and presentation of biomedical data is accurate and complete. Adherence to Amgen Policies， SOPs and other controlled documents
＜Group Purpose＞ Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen’s commercialization process， and continuously improving our processes and developing our talent ＜Job Summary＞ Support the tactical execution and detailed deliverable to support Regulatory Activities including CTN， PMDA consultation， and NDA (eCTD) ＜Key Activities＞ *Oversight service providers for eCTD and/or e-Data *Execute preparation， compilation， and submission of regulatory dossiers according to Japanese requirements *Ensure the contents and format of dossiers conform to internal and external guidelines and regulations *Provide guidance to global teams on the structure of regional dossiers and eCTD Japan specific requirements *Document management *Responsible for ensuring quality control procedures for dossiers and components are in place and adhered to *Evaluate and ensure timely data entry for regulatory registration tracking system *Participate in the development and maintenance of policies， SOPs and associated documents for GRAAS Japan