Tokyo,14.0M ～ 16.0M

Management Consultants welcome

STRATEGY

- Develop long-term strategy and plan as a Japan market, which includes assessment of current environment, defining key objectives, identifying success factors, and comprehending constraints related to the organizational challenges.

- Take leadership operations on long-term strategy and plan, including profitability analysis, process redesign, operational efficiencies, growth strategy, strategic planning, data collection, qualitative analysis, etc.

- Drive annual / quarterly prioritization processes by digesting long-term strategy into mid-term strategy/immediate priorities and visualize company’s overall status and monitor the progress by managing KPIs

CROSSFUNCTIONAL CAPABILITIES

- Support various types of transformation and initiatives within the subsidiary - commercial-related topics and otherwise - and play a lead role in driving changes.

- Support projects include but not limited to agile transformation, go to market strategy, digital capability assessment, customer engagement vision building, demand planning automation, etc.

Hyogo,7.0M ～ 11.0M

- 注射剤及び固形製剤の製品規格試験の実施及び関連する試験法・分析機器のQualification/Validation
- 試験実施に関わる逸脱・変更管理の実施業務
- 米国本社・海外製造所との試験法移管業務
- その他試験実施に関わる管理業務

Tokyo,6.5M ～ 11.0M

治験情報課では、治験由来の症例処理に加え、治験施設に提供する安全性情報の発行、プロトコール等の治験関連文書の作成・レビューを担当しており、がん領域を中心とした治験薬全般に携わっています。また、多くの臨床試験を適切に進めるために、臨床部門、薬事、品質管理、CRAなどのステークホルダーと連携しています。

? 治験薬に関する安全性情報（ICSR、 文献、 集積報告、海外措置情報等）の処理全般（収集、評価、報告）を行う
? 症例処理に関するベンダー管理を行う
? 臨床開発部門と連携し、治験に関わる文書の作成およびレビューを行う（特に安全性に関わるパート）


Preface: Division is working on clinical study with main focus on oncology area, including case processing, summarizing clinical safety information according to protocol, by working with stakeholders (clinical department, QA & RA, CRA etc.) to ensure without compliance issue clinical studies can be ensued.

● Responsible for all aspects of processing and vendor management, etc.
● Responsible for working closely with clinical related department for preparation and reviewing of documents, especially safety related part for clinical study.