Tokyo,8.0M ～ 11.0M

Responsibilities
You will:
?Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits

?Perform CRF review, source document verification and query resolution

?Be responsible for site communication and management

?Act as a communication point between project teams and the site

?Leads project team calls on a country level

?Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level

?Participate in feasibility research

?Support regulatory team in preparing documents for study submissions

?Prepare and participate in site audits and inspections

Tokyo,14.0M ～ 18.0M

Manage Quality Information Management/Quality system group which is responsible for following with a view to total optimization rather than limited optimization.

In addition, promote people growth by supporting OJT activity of group members. Act as Quality responsible for Medical Device in J-QMS ordinance.

?Management of the task of Quality Information Management compliance to PMD-ACT, GQP/QMS regulation and company Quality directives.
-Maintaining GQP/QMS system as MAH
-Managing manufacturers of medical devices

?Management of Product Technical Complaint (PTC), Quality Information of responsible products released to the market.
-Handling PTC from receipt of complaint to reply to customers within PTC cycle time.
-Monitoring and analysis of PTC trend to detect any quality risks in a timely manner.
-Reporting PTC to concerned site / functions via defined platform
-Sharing the quality information with related functions, which can be a critical issue
-Supervising the activity of outsourced companies

?Management of the quality risk of the products released onto the market.
-Analysis of the root cause and confirmation of CAPA regarding PTC of manufacturing process-related or product related
-Analysis of the quality risk based on PTC and report to the management, and share the info on the related functions as appropriate
-Proposal of countermeasure to reduce the quality risk based on PTC
-Support to the new product development or launch in Japan with technical knowledge and feedback from the market

?Management of response to customers about PTC and improvement requests
-Arrangement of proper investigation and clarification of investigation results obtained from investigation site, if needed
-Participating in the Defect Evaluation Committee for reporting to HA
-Management of the effectiveness of the activity of outsourced company

?Management of defect reporting of MD and combination products in corporation with PSPV

?Act as support function of MSG (Soukatsu)
-Coordinate meetings of which MSG is the owner, create and store the meeting minutes.
-Create/revise/obsolete/storage of the SOP and related documents
-Plan/implement/document the training

?Quality system maintenance in accordance with global procedure
-Implementation of country quality review
-Coordinate Quality Audit conducted by global organization
-Coordinate regulatory inspection collaborating with related department
-Activity for audit/inspection preparation (Audit/inspection Readiness)
-Third Party management
-Management of global electronical Quality system as a representative of local market.
-Implement/coordinate Self inspection

Tokyo,14.0M ～ 18.0M

-Reports to Japan Portfolio Project Head are a Member of the Global Project Team to ensure understanding & alignment of the global vaccine development strategy and priorities.

-Works in collaboration with all the Global Project Team members & global functions to develop the Japan project strategy and timelines.

-Ensures integration of the Japan activities across all local Japan functions required to meet the Japan project objectives

-Sets up and leads the Japan Team to drive the execution of the Japan activities

-Leads the Japan team in assessing local project risks, developing risk management /mitigation plans, gaining consensus and support for implementing

-Financial acumen and visibility to project budget

-Ensures that Global team understands and integrates the Japan needs and specificities.

-Ensure effective communication and alliance management with third parties including partner companies, academic groups and joint ventures

-Maintain mechanisms to capture and share knowledge, leverage learning and implement improvements within the project team