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新着求人 SE  (IT-35)
募集職種 外資系製薬企業の Manager, Medical IT
勤務地 東京
会社概要 非公開
求人要件 【主な仕事内容】
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. Atleast 3 years to 5 years in supporting and managing Japan PV IT systems.
・Implemented projects and supported IT systems and handled user issues in PV and or Medical and Clinical systems.
・Good English Speaking, Reading & Writing skills, along with fluent Japanese language skills.
・Worked with global team on global IT projects.
・Worked on Safety system data migration projects.
・Worked 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.
・英語ビジネスレベル以上(TOEIC 740点以上) グローバルとのやりとりが多く発生します。
勤務時間:9:00~17:30(所定労働時間7時間30分)フレックスタイム制度(コアタイム 10:00-15:00)
休憩1時間 【休日/休暇】土・日(完全週休2日制)
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