■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

___________________________

■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。

___________________________

■職務内容

（雇入れ直後 / Immediately after hiring）

Employ expertise to develop programs and initiatives to achive pre-defined policy shaping goals in line with our policy objectives by effectively advocating with policymakers and regulatory authorities. 

Typical Accountabilities:

This role will be responsible for development and execution of healthcare policy advocacy for patient benefits and our business objectives. 
The healthcare policy advocacy of this position will focus on advocacy activities primarily on vaccines and immune therapies.
- Develop and implement advocacy strategies to promote the early adoption of our vaccines into the national routine immunization program.
- Build and maintain relationships with key stakeholders such as vaccine policy experts, government officials, academia, Diet members, industry associations, and patient advocates.
- Monitor and analyze policy developments related to vaccines and immunization.
- Prepare and present compelling evidence and arguments to support the inclusion of our vaccines in the national immunization program.
- Collaborate with internal cross-functional teams (local and global), including regulatory affairs, medical affairs, and marketing, to align advocacy efforts with overall business objectives.
- Organize and participate in meetings, workshops, and conferences to advocate better and earlier access to vaccine products.
- Provide regular updates and reports to senior management on advocacy activities and outcomes.
- This role will report to Director of Government Affairs and Public Policy. 

（変更の範囲 / Scope of change）

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

___________________________

■応募要件

【経験、資格、能力、経験 / Education, Qualifications, Skills and Experience】
＜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＞

• 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

___________________________

■想定年収

規定により優遇

___________________________

■勤務地    

（雇入れ直後 / Immediately after hiring）滋賀県、米原

（変更の範囲 / Scope of change）会社の定める場所

___________________________

・応募＝企業への応募ではありません。

・弊社との面談を希望される場合、この案件にお気軽にご登録ください。

・面談の際に、ご志向などをお聴きし、ご希望に応じた案件もご提案させていただきます。

■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

___________________________

■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。

___________________________

■職務内容

（雇入れ直後 / Immediately after hiring）

TA (Therapeutic Area) Medical Science Director （MSD) is a TA Division Leader, being responsible for leading, managing and developing members of TA Medical Science Department and is accountable/responsible for medical contents/judgements of clinical development strategy of the products within the 
Biopharmaceutical TA portfolio (cardiovascular, renal, metabolic, respiratory, Immunology, Vaccine) and for delivery of medical/scientific contents of clinical development. TA-MSD coaches Project Physician (PP) to deliver right quality of deliverables, to contribute to the progress of relevant projects and to secure optimal patient access to the relevant products in a timely manner.
TA-MSD is responsible to bring up a capability of physicians as future manager and/or leader candidates according to their individual development plan (IDP). S/he makes and implements development/retention plans.TA-MSD acts as a representative physician of TA Medical Science Department against internal and 
external stakeholders, and facilitates engagement with Global and regional (ex. China) senior physicians to provide TA/Disease Area (DA) as well as Key External Experts (KEEs) in responsible TA. TA-MSD is a playing manager and expected to manage 4 project physicians(50-70% of time), while being assigned to specific projects as a PP. 

（変更の範囲 / Scope of change）

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

___________________________

■応募要件

経験 Experience

<必須 Mandatory>

製薬業界での業務経験、臨床医経験、研究歴

<歓迎 Nice to have>

製薬業界での臨床開発経験5年以上、マネージャー経験

資格 License

<必須 Mandatory>

医師免許 医学博士

<歓迎 Nice to have>

循環器、腎臓、内分泌、呼吸器、自己免疫疾患、感染症領域の専門性

能力 Skill-set

<必須 Mandatory>

communication skill, leadership, strategic thinking, logical thinking

<歓迎 Nice to have>

project management skill

語学 Languages

<必須 Mandatory>

日本語 Japanese : ネイティブレベル

英語 English：ビジネスレベル、TOEIC850点以上程度

___________________________

■想定年収

規定により優遇

___________________________

■勤務地    

（雇入れ直後 / Immediately after hiring）滋賀県、米原

（変更の範囲 / Scope of change）会社の定める場所

___________________________

・応募＝企業への応募ではありません。

・弊社との面談を希望される場合、この案件にお気軽にご登録ください。

・面談の際に、ご志向などをお聴きし、ご希望に応じた案件もご提案させていただきます。

■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

___________________________

■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。

___________________________

■職務内容

（雇入れ直後 / Immediately after hiring）

•    Ensure Pharmaceutical Quality System and supporting processes are in place and implemented across the site for compliance and license to operate.
•    Ensure compliance with our Quality standards, Safety Health and Environment requirements.
•    Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area. 
•    Direct quality initiatives and improvement program aimed at ensuring compliance, continuous improvement, enhancing commitment to quality and improving profitability.
•    Leading all internal and external inspection management.
•    Act as point of contact for regulatory bodies at site, dealing with and resolving the complex issues.
•    Be responsible for ensuring that the requirements and implications of all applicable external regulations are understood, the risks and opportunities are identified during assessment and communicated to the right stakeholders for information, advice and decision.
•    Be responsible for ensuring that we are involved with and influential in key external organizations and events that interact with the local agencies that oversee and regulate the pharmaceutical industry within Japan.
•    Proactively look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
•    Proactively work with Regional/Global Quality network to share good practices and learning. Lead significant local cross-functional initiatives and above site initiatives in the regional/global network.
•    Lead and provide guidance in the daily job of the team. Build and develop team and personnel capability. Optimize performance outcomes of direct reports and ensure high quality IDP review.
•    Build and develop strong Quality talent pipeline for site Quality function and wider network. effectively.

（変更の範囲 / Scope of change）

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

___________________________

■応募要件

【経験/ Experience】

- 必須/ Mandatory

•    Substantial relevant experience in pharmaceutical quality, manufacturing or regulatory roles
•    Experience working within cross functional and global teams 
•    Track record of working with regulatory health authorities/ stakeholders/ government bodies / industry associations
•    Experience of establishing and sustaining regulatory compliance culture 

•    Extensive work experience and deep understanding of culture(s) in Japan market 
•    Familiarity with the regulations in Japan
•    Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
•    Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

- 歓迎/ Nice to have

•    Lived and worked outside of Japan
•    Experience within a complex manufacturing/supply site environment
•    Experience in GQP roles

【語学、スキル等/ Languages/Skills】

- 必須/ Mandatory

•    Fluent in Japanese and English
•    Bachelor’s degree and Licensed Pharmacist (Japan)
•    Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

- 歓迎/ Nice to have

•    Ability to work externally and represent us with external industry associations

•    Excellent knowledge of our policies, procedures and guidelines

___________________________

■想定年収

規定により優遇

___________________________

■勤務地    

（雇入れ直後 / Immediately after hiring）滋賀県、米原

（変更の範囲 / Scope of change）会社の定める場所

___________________________

・応募＝企業への応募ではありません。

・弊社との面談を希望される場合、この案件にお気軽にご登録ください。

・面談の際に、ご志向などをお聴きし、ご希望に応じた案件もご提案させていただきます。

■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

___________________________

■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。

___________________________

■職務内容

（雇入れ直後 / Immediately after hiring）

•    Leads Quality function in a manner that maximises its contribution to the achievement of business objectives, profitability and return on investment. May have direct contribution to achievement of objectives across our more broadly.
•    Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit. 
•    Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency. 
•    Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through management reviews and through advocating continuous improvement. 
•    Is responsible for ensuring that the requirements and implications of all applicable external regulations and our Quality Management System and Code of Ethics are understood and effective implementation processes are put in place in all parts of the business area for that is responsible for. 
•    Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area.
 •    Is responsible for ensuring the professional development of the organisation in order to provide sufficient qualified resources and strong succession pipeline for site quality function and wider network. 
•    Is responsible for ensuring that we are involved with and influential in key external organisations and events that interact with the government agencies that oversee and regulate the pharmaceutical development, manufacture and quality systems for medicines within Japan. 
•    Is responsible for the Management review process and outputs for the site and for ensuring appropriate management focus on quality and compliance topics affecting Japan Operations business.
•    Leads the Quality elements of change programmes and projects in their site, working with the business to prioritise delivery of the Global Quality strategy.
•    Optimises key relationships with organisations (e.g. external regulatory bodies and Quality networks) to take full advantage of efficiencies and meet compliance obligations.
•    Works in partnership with the business and specialist Quality colleagues to ensure that an environment of continued professional development is created and individual and team performance is managed effectively.

（変更の範囲 / Scope of change）

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

___________________________

■応募要件

＜必須 / Mandatory＞

'-Leadership of significant cross-functional change programmes/initiatives with Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
-At least 10 years’ experience in the pharmaceutical industry including at least 3 years’ experience in Clinical Development / Assurance / Advice
-Well-informed understanding of drug development process and related GCP activities and understanding of skills and knowledge required for successful delivery of a clinical trial, e.g. GCP, monitoring, data management, study drug delivery etc.
-Proficient knowledge of local and international regulations and guidelines
-Knowledge of Clinical Procedural Documents

＜歓迎 / Nice to have＞

-Process Management including developing / reviewing Procedural Documents in Japanese / English
-Professional excellence: Background of high professional achievement and willingness to encourage this in others

【資格 / License】

＜必須 / Mandatory＞

Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.

＜歓迎 / Nice to have＞

MBA, Project Management Professional(PMP)

【能力 / Skill-set】

＜必須 / Mandatory＞

-Leadership
-Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills in a multicultural environment
-Integrity and high ethical standards
-Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. 
-Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
-Makes effective decisions despite uncertainty and/or incomplete information.
-Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.
-Seeks diverse views and incorporates them where appropriate in order to develop better proposals and creative solutions for the business.

＜歓迎 / Nice to have＞

Consistently exhibits Leadership capability as below
- Commitment to Customers & Integrity; Focuses on What’s Important: Balances and prioritizes across diverse and competing customers, needs and opportunities. 
- Demonstrates the courage to make tough and ethical decisions about where to devote resources.

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：Native Level

英語 English：Business English (Achieve common understanding at the context level with customers, and at monthly global meetings)

___________________________

■想定年収

規定により優遇

___________________________

■勤務地    

（雇入れ直後 / Immediately after hiring）滋賀県、米原

（変更の範囲 / Scope of change）会社の定める場所

___________________________

・応募＝企業への応募ではありません。

・弊社との面談を希望される場合、この案件にお気軽にご登録ください。

・面談の際に、ご志向などをお聴きし、ご希望に応じた案件もご提案させていただきます。

■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

___________________________

■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。

___________________________

■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

___________________________

■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

___________________________

■想定年収

規定により優遇

___________________________

■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

___________________________

・応募＝企業への応募ではありません。

・弊社との面談を希望される場合、この案件にお気軽にご登録ください。

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• 【社長室】CSO（最高戦略責任者）候補
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  • 仕事概要
  • 必須スキル
  • 歓迎スキル
  • 求める人物像
  • 応募概要
  • 企業情報