By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description:
Please note this job requires business level Japanese in speaking, writing, and reading.:
タケダの紹介:
タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。
タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです。従業員は創業時から受け継いできたタケダの価値観であるタケダイズム(誠実=公正・正直・不屈)を道しるべとしながら、患者さんに寄り添い(Patient)人々と信頼関係を築き(Trust)社会的評価を向上させ(Reputation)持続可能な事業を発展させる(Business)を日々の行動指針としています。
"Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We're looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates
Integrity, Fairness, Honesty,
and
Perseverance,
with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
募集部門の紹介:
PMS ストラテジックマネジメントは、MAHの責務である製造販売後調査(PMS)と再審査申請に責任を持って業務を行っています。そのため、Oncologyを含む3つのスタディーマネジメントグループと2つのkey groupがあります。この2つのkey groupは、再審査制度とGood Post-marketing Study Practice (GPSP)に関する規制要件を満たすため、業界トレンドに合わせた分析と方針を決定するGPSP Management groupと、全てのTaskのFoundationとして組織を機能させるOperational Excellence groupがあります。また、医療現場におけるField MonitoringはCROのPMS専任モニターが担っています。
私たちは、部門ビジョンを実現するために以下を重要な部門要素として設定しています。
- 品質とコンプライアンスを担保することで再審査の規制要件を満たす
- 革新的なアプローチによって業界をリードする
- エビデンスジェネレーションの強化とPMSデータの価値を最大化する
- オペレーショナルエクセレンスを強化する
- 社内外に認知されたタレントを育成する
職務内容:
- 再審査に関する規制要件業務の遂行
- 規制要件の遵守とProcess Improvement
- 上市製品の再審査申請、GPSP Inspection
- PMSのバックオフィスCRO Management
- PMSを実施するための基盤作り
- Cross Functional initiativeのLeadまたはMember
- Business Modelの提案
応募要件:
<学歴>:
学士以上
<実務経験>:
以下のいずれかの経験を有していること
- 3-5年以上のGCP/GPSPの実務経験
- 製薬会社、CRO、ヘルスケア関連コンサルティング会社、またはアカデミアにおいて合計3年以上のPMSモニタリングおよび再審査申請業務の経験、または臨床研究・治験関連業務の経験
- 再審査申請又は新薬承認申請の経験
- ビジネスモデルの提案・導入
<スキル・資格>:
Management skill:
Leadership/Ownership/Decision making/ 問題を積極的に予測して解決する能力/ Root Cause Analysis及びFact Based Approachを実践する能力/Communication/IT関連スキル
Professional skills(次のいずれかのスキル):
Project Management, Study planning, CRA/PMS monitoring, Regulatory affairs
<語学>:
TOEICスコア730点以上
<その他>:
3日/週、又は月間約2/3以上、Office勤務が出来る方
出張に対応できる方
求める人物像:
- Cross Functional Teamの中で、未経験の業務であっても、関係者と良好な協力関係を築きながらProjectを強力に推進できる方
- 個人の経験を組織全体のCapability向上に役立てることができる方
- 外部環境変化に応じた新たな業務に対して興味を持ち、AgilityをもってLeadできる方
仕事のやりがい:
医薬品の安全性/有効性を科学的に確認・公表することを通じて、医療への貢献を実感できる
本職務で身につくスキル・経験:
科学的な企画力・判断力・考察力
行政通知を理解するスキル/それを実務に導入することで得られる経験
タケダのDE&I
Better Health, Brighter Future:
Takeda Compensation and Benefits Summary:
- Allowances Commutation, Housing, Overtime Work etc.
- Salary Increase Annually, Bonus Payment Twice a year
- Working Hours Headquarters (Osaka/ Tokyo , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
- Holidays Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
- Paid Leaves Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
- Flexible Work Styles Flextime, Telework
- Benefits Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
- It is possible the job scope may change at the company's discretion.
- It is possible the department and workplace may change at the company's discretion.
Locations:
Tokyo, Japan
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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