JOB INFORMATION
求人情報

求人番号 75660-069

製薬・医療機器業界

外資系 メディカル

Manager, Medical IT

  • 年収
    非公開
  • 勤務地
    東京都
  • 英語力
    上級

外資系製薬企業のメディカルITポジションです。

職務内容
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.

応募条件
・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.
Preferable:  
・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.
資格・ライセンス
・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
無料オンライン登録

厳選求人詳細

  • 外資系 メディカル

    サービスデスク サービスアドバイザー

    このポジションでは、ソフトウェア導入後のカスタマーからの各種依頼・問い合わせへの...

    この求人の詳細を見る
  • 外資系 メディカル

    購買マネージャー

    ・コスト削減・安定供給のための、製剤に係る各種手配 ・コスト削減・安定供給のため...

    この求人の詳細を見る
  • 外資系 メディカル

    IT Strategic Digital Transformation Lead

    【業務内容】 Our IT team is looking for an in...

    この求人の詳細を見る
  • 無料登録

求人検索

  • 管理部門の転職情報
  • ISSコンサルティング採用情報
  • オンライン登録

転職のご相談、求人応募・お問い合わせには、
まず無料登録をお願いします。

無料オンライン登録

SNS

企業インタビューやセミナー
業界転職情報をお届け!

Arrow