Manager, Medical IT
- Responsibility for IT support for Product Safety Risk Management (PV), Medical Affairs and Clinical Research business functions;
1.Leading project planning and implementation of Japan local IT projects for these functions.
2.Coordinating with external vendors and ensuring they deliver the services for the IT projects.
3.Coordinating with business functions to understand and capture the user requirements and user acceptance of the technology solutions provided to them.
4.Collaborating with the Global IT team for implementation of Global projects where the project scope also involves Japan rollout.
5.Support existing applications that are Live. Coordinate with the vendors hosting the solution or providing technical solutions to fix the issues reported by the Business users.
6.Prepare the Computer System Validation documentation required for the GxP systems. Coordinate with the IT Validation Manager and Quality Assurance for assistance and approval of the CSV documents.
7.Assist in capturing the new business needs and budget estimate preparation.
8.Track and monitor the contracts and agreements of external vendor hired for the Japan IT project.
9.Local IT Business Partnering and system support of Regulatory Affairs, Quality and R&D as member of Japan IT team.
- ・7 years in IT and min. 3 years in supporting and managing Japan PV, Medical, Clinical, Regulatory systems (e.g. Argus, CW5, Perceive, Aris G).
・Project management, support IT systems and handle user issues.
・Good English speaking, reading and writing skills, along with fluent Japanese language skills.
・Working experience in Pharmaceutical company or IT consulting company providing services to Pharmaceutical companies in PV, Medical, Clinical, Regulatory areas.
・Knowledge of PMDA regulations in PV and or Medical domain. Knowledge of E2B R3 and IDMP regulations.
・Computer Science graduate.
・Knowledge of Argus Safety / CW5 / Perceive / ArisG
・Knowledge of Computer System Validation (CSV) and Change Management process.
・Authored or executed IQ or OQ test scripts or CSV documents.
・Knowledge of PL SQL and Query writing, or custom report development.
英語力 TOEIC Score 800