求人・転職情報

Working with the Head of DSPV-Japan, this role is responsible for ensuring optimal patient safety as first priority by developing a state-of-the-art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance in Japan.

This role is responsible for promoting quality and regulatory compliance for pharmaceuticals and medical devices through GMP/GQP/QMS activities in Japan.
The position supervises local Quality Assurance and Quality Control operations, including product release, audits, change control, and regulatory correspondence.
As the Quality Assurance Officer (Hinseki), the role leads the GQP team and collaborates with internal and external stakeholders to ensure compliance with local and global requirements.

【職務概要】
Medical Affairsは、医療・科学分野の窓口として、医療従事者（HCP）、医療学会、規制当局、学術機関などの外部関係者と連携します。フィールドおよびオフィスの医療チームと協働し、科学的・医療的専門性の維持・向上を図りながら、製品価値最大化と医療戦略の実行を支援します。

【主な責務】
チームメンバーの育成と変化への対応をリードし、部門内外の連携を促進。
医療機関や関係者から得た情報を活用し、製品の安全かつ効果的な使用を促進。
医療戦略や臨床計画の策定と実行に貢献し、未充足医療ニーズやデータギャップの解消を目指す。
医療計画に沿った活動（アドバイザリーボード、教育セミナー、科学的コミュニケーション等）を実施。
非プロモーション活動を通じた医療専門家との科学的交流を推進し、信頼関係を構築。
医療情報の適時収集と提供、研究助成のフォローアップを行う。
医療・科学的資料の作成、リアルワールドエビデンス生成、研究支援を実施。
主要医療専門家との長期的な関係構築に努め、医療・公衆衛生の洞察を社内に共有。
関係部門と連携し、未充足医療ニーズの分析や解決策の検討、医療教育プログラムの提供を行う。
社内規則や法令遵守、適正なコミュニケーションを実践。
副作用報告義務を認識し、適切な安全情報の収集・報告を行う。
必要に応じて、新規治療候補の特定や重要な供給問題への迅速対応も支援。

医療制度・政策に関する情報収集、関係先との関係構築
チームマネジメント

<Job Description>

Cell Therapy Field Clinical Advisors (FCAs) are part of the Global Cell Therapy Clinical Operations team and play a critical role in the successful execution of cell therapy clinical trials—driving recruitment, retention and safety management while enabling early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline engagement. The role requires close collaboration with other CTCO Functions, Clinical Development, and Medical Affairs across multiple indications and business units to advance AstraZeneca’s diverse cell therapy portfolio.


<Typical Accountabilities>

Scientific Expertise and Education
￣￣￣￣￣￣￣￣￣￣￣￣￣￣￣￣
・Pipeline Mastery at Scale: Build and continuously maintain deep knowledge of AstraZeneca’s cell therapy pipeline across multiple indications and assets.
・Recognized Thought Leadership: Establish and sustain highest-level scientific and medical expertise in cell therapy; recognized internally and externally as a go-to expert, shaping guidance, training, and best practices for assigned protocols and sites
・Strategic Portfolio Communication: Lead site-facing and expert stakeholder communications that clearly convey AstraZeneca’s cell therapy strategy, portfolio breadth, and product differentiation; ensure consistent, compliant messaging across regions.
・Initiative Ownership and Execution: Design, lead, and implement high-impact local initiatives with trialists and key experts to support R&D or study implementation, aligned with GPT, Global R&D, and Country Medical Affairs; track outcomes and scale successful approaches.
・Education Gap Identification and Closure: Systematically assess educational needs across owned sites, deliver advanced protocol training, and escalate patterns to Global Clinical Development with recommendations for enterprise-level solutions.
・Insight Generation and Influence: Capture, synthesize, and deliver actionable field insights (feasibility, operational bottlenecks, patient pathways) to global and local stakeholders; drive early risk identification and influence protocol/process adjustments.

Clinical Trial Support
￣￣￣￣￣￣￣￣￣￣
・Advanced Education and Readiness: Lead delivery of SIV content; provide advanced protocol education and competency-based staff training to ensure readiness, compliance, and consistency across sites and indications. Drive patient selection quality, safety management, and site-specific action plans; deliver measurable improvements in start-up timelines and protocol adherence
・Recruitment and Retention Performance: Implement targeted protocol education (e.g., inclusion/exclusion criteria application etc.) to uplift enrolment rates, reduce screen failures, and minimize attrition.
・Issue Triage, Escalation, and Risk Mitigation: Serve as the primary field point for protocol and clinical issues; triage and escalate appropriately, drive root-cause analysis, and implement corrective/preventive actions to reduce deviations and data queries.
・Structured, Compliant Scientific Exchange: Lead timely, high-quality scientific and medical communications with trialists and internal partners, ensuring alignment with compliance policies and legal requirements; standardize messaging and capture learnings for reuse.
・Insight Loop and Continuous Improvement: Systematically capture site-level insights; synthesize trends for study teams and cross-functional stakeholders, influencing protocol/process adjustments and scaling proven practices.

Operational
￣￣￣￣￣￣
・Cross-functional orchestration: Lead coordinated delivery with CTCO Functions, Clinical Development, Medical Affairs, Supply/Logistics, Patient Operations and Country Ops to ensure rapid, reliable service to internal stakeholders and study sites.
・Portfolio coverage and resiliency: Provide proactive coverage for other FCAs and high-priority sites; implement standardized playbooks to maintain continuity of operations during surges, vacations, or escalations.
・Regulatory and policy stewardship: Maintain current knowledge of local regulations, guidelines, codes of practice, and AstraZeneca policies relevant to Clinical Development; translate requirements into practical site actions and support inspection readiness.
・External scientific engagement: Attend and contribute at relevant scientific meetings and conferences; synthesize takeaways into concise briefs and recommendations for study teams and operational processes.
・Innovation sourcing and scaling: Build relationships with industry leaders and ecosystem partners; identify, pilot, and scale innovations (e.g., workflow tools, logistics optimizations, patient support solutions) that improve cycle times, quality, and site experience.

Cross Functional
￣￣￣￣￣￣￣￣
・Global workstreams: Provide country specific field insights and subject-matter expertise to priority global initiatives; review/shape core strategies and deliverables to enable scalable, locally compliant adoption.
・Medical Affairs: Partner on scientific strategy, congress/education plans, and field content; ensure accuracy, balance, and governance compliance across materials and training.
・Commercial (within governance): Coordinate through approved interfaces to align on market dynamics and objectives
・Evidence and insights: Elevate actionable field signals to inform global research strategy and lifecycle plans; ensure traceability from signal to decision.
・Governance: Operate within AZ policies/SOPs and local regulations

Impact
￣￣￣
・Operational velocity and quality: Directly improve speed, quality, and consistency of AstraZeneca’s cell therapy trials—reducing cycle times, elevating protocol adherence, and accelerating patient access to innovative treatments.

職務内容

日本における医薬品（化学合成品、バイオ医薬品）の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者

・申請戦略・申請計画のCMCパートについて立案・遂行
・薬事関連の当局相談に係る戦略策定及び遂行
・製造販売承認申請業務（CMCパート）
・導入案件のCMC薬事関連の評価
・グループメンバーの教育訓練及び人財育成

Job Description
As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company’s vision/mission/value.

・Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
・Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discussions are anticipated.
・Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.
・Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.
・Lead a group of individuals to support group’s goals according to agreed timelines, standards and business priorities

主な業務内容：
・組織または特定の治療領域の戦略的な科学的、治療的、および商業的ニーズを満たす事業開発機会を創出する。
・リーダーシップと戦略構築
・プロジェクト管理：メディカルケミストリープロジェクトの設計、実行、および管理を監督し、タイムリーな進捗と高品質な成果を確保する。
・チーム開発：社内の毛ミスとチームを指導・育成し、協力的で革新的な職場環境を醸成する。
・他部門との横断的なコラボレーションの推進

職務内容

日本における医薬品（化学合成品、バイオ医薬品）の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者

・申請戦略・申請計画のCMCパートについて立案・遂行
・薬事関連の当局相談に係る戦略策定及び遂行
・製造販売承認申請業務（CMCパート）
・導入案件のCMC薬事関連の評価
・グループメンバーの教育訓練及び人財育成

Job Description
As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company’s vision/mission/value.

・Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
・Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discussions are anticipated.
・Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.
・Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.
・Lead a group of individuals to support group’s goals according to agreed timelines, standards and business priorities

Project Physician (PP) is a medical expert who is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for AZ assets in Japan.His/Her accountability/responsibility is mainly at project-level, however, he/she is also involved in study-level activities as needed.

Other major responsibilities/accountabilities include but are not limited to:

Generate Japan clinical development strategy in collaboration with Clinical Scientist (CS) by providing expert knowledge as a physician-scientist, influencing the study design such that it reflects clinical practice, evolving landscape of medicine, regulatory and reimbursement requirements and that it meets the strategic program objectives.
Draft and/or review study design, regulatory documents to ensure alignment with agreed clinical development strategy.
Be responsible/accountable for KEE engagement from R&D perspectives including but not limited to group advisory board mtg and 1:1 consultation as local internal medical expert to lead scientific discussion for clinical development strategy in collaboration with CS and global teams.
Act as a study physician of Japan standalone studies as well as support global study physicians of global leading studies

1. Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.

2.Drive assigned projects forward as Japan project team lead with Japan cross functional team members. Interact regularly with Global Development Team Lead to exchange project information including strategic aspects.

3. Provides scientific support to The Company functions including but not limited to Clinical Development, Clinical Operations, Biostatistics, Data Management, Medical Writing, Clinical Pharmacology and Medical Affairs.

4. Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support The Company’s development programs.

5. Responsible for the design of Japanese clinical studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols.

6 Prepares and presents （if applicable） scientific information concerning The Company’s development programs internally and at external meetings as required.

7 Critically assesses requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials and Grant requests:

8 Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings. Attends and presents The Company position at informal and official Consultation meetings with PMDA and MHLW.

9 Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.

10 Coordinates the preparation and/or review of regulatory documentation including but not limited to IND annual reports, IND safety reports, Investigator Brochures and J-NDAs.

臨床および研究開発の専門知識と指針を地域・国レベルで提供し、臨床チームのリーダーとしてグローバルプロジェクトチームの臨床代表を務めます。担当疾患領域の専門家として、臨床開発計画や試験関連文書について規制当局や独立委員会、アドバイザリーボードと議論を主導。地域やグローバルの関係者と連携し、申請資料の臨床部分の責任を担い、規制当局との事前相談や申請会議にも関与します。

臨床チームのリーダーとして、グローバルプロジェクトチームの臨床代表を務め、担当する疾患領域の専門家として、臨床開発計画（CDP）や試験関連文書（プロトコル、結果など）について、規制当局や独立データモニタリング委員会、アドバイザリーボードなどと議論を主導します。

The Regulatory Affairs Senior Manager is responsible for leading regulatory activities from development through life cycle management in collaboration with global and Japan stakeholders. Key responsibilities include managing interactions with health authorities, leading NDA and sNDA submissions, preparing Japan-specific regulatory documents, overseeing post-marketing change control processes, and managing electronic package inserts and promotional material reviews. The role also involves mentoring team members, managing vendors, supporting SOP updates, and ensuring compliance with regulations while driving process improvements.