職務内容

 

■働く魅力：Great Place to Work®に認定企業

・働きがいのある職場: Great Place to Work®に認定されており、社員が誇りを持って働ける企業文化が醸成されています。

・柔軟な働き方: コアタイムなしのフレックスタイム制度を導入しており、始業・終業時間を自由に調整できます。

・社員の成長支援: 「Learning for Life」プログラムを通じて、リーダーシップ研修やメンタリング制度など、継続的な学習機会を提供しています。・多様性とインクルージョン: LGBTQIA+の支援や障がい者雇用の推進など、多様なバックグラウンドを持つ社員が活躍できる環

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■企業の魅力：

・抗がん剤領域の強さ: 競合他社よりも積極的な新薬開発を進めており、特に免疫療法や分子標的治療に強みを持っています。

・日本市場での存在感: 日本国内の外資系製薬会社の売上ランキングでは、トップに位置しており、競合他社よりも市場での強い影響力を持っています。

・ 研究開発への投資: 年間数十億ドル規模の投資を行い、循環器・代謝疾患、呼吸器疾患などの重点領域で競争力を維持しています。

・ 戦略的提携: 他の製薬企業との提携を積極的に進め、特にオンコロジー領域での成長を加速させています。

境を整えています。

 

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■職務内容

（雇入れ直後 / Immediately after hiring）

Associate Director Clinical Quality Management (ADCQM) leads the planning and implementation of all quality activities adapting to changes in the environment through relevant Clinical Quality Management System. ADCQM is individual contributor and skill expert which meets organizational needs and professional role model for CQM. ADCQM is responsible for proactive contribution to Japan Development Operations(J-DO), and global member in Quality Management or Quality Assurance to develop capabilities to 
achieve high level of performance and productivity in Japan/global.
ADCQ is responsible for
• Contribute to the effective execution and implementation of the CQM, J-DO and R&D strategy.
• Lead the planning and implementation of all quality activities in J-DO through relevant Clinical Quality Management System.
• Drive the robust communications/networking with our global members to ensure our processes are aligned and that we are consistently applying processes and adapting to changes in the environmentin the document quality areas.
• Ensure Always Inspection Ready(AIR) including PMDA, EMA, FDA and other Health Authority inspection ready in Japan:
o Guides study teams to adopt clinical study audit and inspection-ready standard
o Collaborates with DOLT to ensure the all Clinical Studies delivered by J-DO are inspection ready and supports J-DO-related audits and inspections
• Lead to analyses and identifies improvement opportunities by collecting quality related data / quality issue (QI) and communicating with Process Owners(PO), System Owners, Subject Matter Experts and DOLT.
• Lead to assist study teams during development and implementation of CAPA plans and investigations.
• Provide a robust quality risk and issue management expertise to J-DO.
• Provides a compliance risk and issue management service to J-DO.
• Ensure that relevant new regulations are assessed and appropriately encompassed in J-DO.
• Build and maintain strong customer relationships with QA, Compliance Manager, PO, and DOLT etc.
• Leads keeping simplification and consistency of description in Procedural Document including Local SOP and working instructions, working package and training package within DO, R&D Japan and Global.
• Model behaviours that foster Astroureneca’s preferred work environment, including adherence to our Code of Ethics

 

（変更の範囲 / Scope of change）

会社の定める業務/Business as defined by the company

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■応募要件

＜必須 / Mandatory＞

•    Diet members & government engagement and policy advocacy in healthcare for 5 years or more
•    Bachelor's degree
•    Capability of stakeholder engagement strategy development
•    Capability of relationship building with policy stakeholder
•    Knowledge in policy development process

• Knowledge in healthcare policy and policy development processes
• Good story teller
• Team working spirit and skills
• Fluency in Japanese both verbal and written. Good at English reading and writing

＜歓迎 / Nice to have＞

•    Engagement with healthcare policy key opinion leaders
•    Master of Business Administration, Master of Public Health, Master of Public Policy, Medical Doctor, Pharmacist 
•    Fluency in English speaking

【主な利害関係者 / Key Stakeholders】
＜社内 / Internal (to AZ or team)＞

• Vaccine Business Units, Medical Affairs, R&D 
• Corporate Affairs (Regional Health Policy, Pubic Relations, and Patient Advocacy)
• Japan Leadership Team

＜社外 / External ＞

• Diet Members
• Government
• Public Policy/Government Affairs Agencies
• Industry Associations
• Key Opinion Leaders in Public Policy/Health Policy Academia 
• Key Opinion Leaders in Scientific Societies

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■想定年収

規定により優遇

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■勤務地    

（雇入れ直後 / Immediately after hiring）東京都23区

（変更の範囲 / Scope of change）会社の定める場所

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・応募＝企業への応募ではありません。

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