Region MRI Cinical Applications Leader， APAC / 社名非公開
|職種||Region MRI Cinical Applications Leader， APAC|
The role will lead applications excellence ＆ leadership in the GE MRI business， as part of the APAC ＆ India Marketing team， and will have focus in Japan， but also integrate and at times support across the region. They will be responsible to manage and lead the applications team to support the needs of our customers. This role will support the development and collaboration with our KOLs， site visits and optimization of the clinical protocols and workflow to meet regional VOC of our customers.
Provide advanced MRI application support to our customers， both new
and installed base， including product training and protocol and workflow
・Clinical Radiographer background with experience in MRI， 5+ years experience minimum.
・Application experience of MRI equipment， both
1.5T and 3T， preferably in GE MRI systems.
・Excellent Interpersonal skills and working as part of a dynamic team environment either as team leader or individual contributor.
・Knowledge of regional market place and dynamics.
・Strong communication skills， Verbal and Written.
・Fluent English and Japanese. Additional languages are an advantage.
・Willingness and ability to travel occasionally within APAC and India.Percentage of time required for travel is flexible.
optimization to meet customer needs and ensure Customer Satisfaction.
・Provide training to the region Sales teams to support the clinical
differentiating value of our products. This includes: understanding clinical
weaknesses/strengths of competition， translate our strengths into simple
messages， produce the clinical proofs elements， deliver training.
・Lead and identify the training needs and actions of the clinical applications
teams of his/her region. They are responsible for keeping internal training
material updated and delivering training on specific advanced topics.
・Develop and maintain good long term customer relationships， KOLs， and high
customer satisfaction and maintain customer profiles， including key decision
・Bring deeper engaged support to KOL sites， stimulating evaluation of new
techniques and publications of results (peer-reviewed articles and Signa
Pulse). Responsible for the maintenance and optimal operation of Show Sites.
This includes: optimal training of radiographers， optimized protocols， clinical
case library， actual support during visits.
・Organize product demonstrations， sites visits and follow up.
・Communicate customer situation and dynamics to/from the field.
・Communicate effectively with members of sales/marketing/service team.
・Ensures knowledge of and compliance with Company policies and quality
|年収||800万円 - 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