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  Job number: JN -012026-199599 Posted: 2026-01-28

  メディカル モニター（Associate Medical Director）

  医師免許をお持ちの方必見です。

  10 - 13 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  Company overview

  Leading global CRO company
  We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.

  Responsibilities

  グローバル臨床試験における安全性管理・医療判断を担うメディカルモニター（Associate～Medical Director）を募集します。日本拠点からAPAC・グローバルチームと連携し、治験に参加する被験者の安全性確保、SOP/ICH-GCP遵守、医療判断、プロトコル適合性の評価などを包括的にリードするポジションです。完全在宅勤務が可能で、医師としての経験をグローバルに拡張できる環境です。
  職務内容：
  治験安全性管理：AE/SAE、検査異常、併用薬、除外/適格基準などの医療判断
  SAE医療レビュー、逸脱判定、盲検解除判断
  プロトコル関連の医療相談への回答、治験医師・KOL・クライアントとの医療協議
  APAC/グローバルMMとの連携・判断共有
  医療パートの教育：プロトコルトレーニング、治療領域トレーニング
  データレビュー（Patient Profile、Coding Listing など）
  ICCCレビュー、医療的リスク評価
  Investigator Meeting等での医療パート説明
  ビジネス開発支援（医療プロセス説明・顧客折衝）
  ※月2回程度、最寄り拠点への出社あり※深夜会議や土日出張が発生する可能性あり（特に試験開始時期）

  

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  Job number: JN -012026-199224 Posted: 2026-01-28

  【大阪】再生医療等製品のCMC研究および製品化検討（研究員またはリーダー候補）

  能力次第で様々な成長の機会を掴んでいただける可能性があります。

  6 - 10 million yen Osaka Pharmaceutical Research & Development

  ---

  Company overview

  A pharmaceutical manufacturer listed on the First Section of the Tokyo Stock Exchange.

  Responsibilities

  ■職務内容：研究開発段階にある再生医療等製品（特に細胞加工製品）のCMC研究および製品化研究製剤化検討（剤型設計、保存法の開発）
  投与デバイス開発
  製法検討（主に下流工程）
  その他周辺技術（製造機器、容器施栓系、輸送法等）の開発
  治験施設への調製手技移転
  日米における治験届・承認申請／IND・BLA業務
  上記に限らず、細胞加工製品の開発において初期から後期まで幅広い分野で活躍いただきます。
  ■この仕事の魅力：新たな医療ソリューションの社会実装・事業拡大の最中にある革新的な再生医療等製品の開発においては、CMCの貢献できる範囲は広く、意欲さえあれば、セクションの垣根を越えて、未知の領域に幅広く挑戦していただくことができます。また米国子会社や海外医療機関との連携によるグローバル開発を進めており、国際感覚やダイバーシティを感じることができる環境です。
  
  ■入社後のキャリアパス：業務に必要な専門知識を磨いて頂くため、国内外の学会や研修に積極的に参加することを奨励しています。また海外子会社と協働して医薬品の研究開発を効率的に進め、且つグローバルな視点で考動できる人材を育成するために、海外子会社への短期或いは長期派遣の機会もつくっています。更に、立候補制による海外留学公募制度や他部門への短期派遣制度を設けています。
  長期的なキャリアパスとしては、専門性をより高め個人の力で成果を出すスペシャリスト人材、あるいは組織力を最大限に活かして成果を出すマネジメント人材に分かれ、各人の資質や希望を踏まえて、上司と相談しながらキャリアパスを描いて頂く事が可能です。
  製剤研究ユニットには他社で活躍後キャリア入社した社員も多く、すぐに職場に馴染み、前職でのご経験を活かして活躍されています。入社後早期にマネジメント職に着任頂いた方もおり、能力次第で様々な成長の機会を掴んでいただける可能性があります。
  
  ■職場の雰囲気：40歳未満が6割を占め、若く活気のある職場です。専門性の高いベテランのバックアップの下、若い時から重要な業務にアサインされ、グローバル開発に挑戦することが出来ます。高い心理的安全性が担保されており、若手から年長までが、垣根なく意見し合い、チームで難題を超えて、革新的な製品を世に届けようとアジャイルに取り組んでいます。
  

  

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  Job number: JN -012026-198931 Posted: 2026-01-28

  QARAマネージャー

  欧州発歯科材料のグローバルメーカー◇品質保証・薬事部門を牽引◎／英語スキル活かせる

  10 - 13 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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  Company overview

  Leading international production of artificial teeth and dental company established in Zurich.

  Responsibilities

  
  同社は、100年以上前にスイスで創立された、
  世界有数の歯科メーカーの日本法人としておよそ20年前に設立されました。
  業界内でも評判の高いオールセラミックスをはじめとした歯科材料・歯科機器を輸入・販売しています。
  そんな同社にて【QARAマネージャー】
  としてご活躍いただけませんか？
  ━━━━━━━━━━━━━━━
  ■具体的な業務内容
  総括製造販売責任者（医療機器、医薬部外品）
  国内品質業務運営責任者の業務（兼務）
  ISO13485及びQMS省令に関連する業務市場への出荷判定およびその記録の管理
  最終製品の保管場所の管理
  薬機法で定める品質の合意文書の管理・更新
  不適合品の取り扱い全般、回収対応
  品質管理に必要な監査の対応（内部と外部）
  SOPその他文書・記録の管理と維持
  
  QARA（品質保証・薬事）部門のマネジメント（現在は部下1名の予定）
  ラベリングのデータ管理とチェック
  返品の再出荷判定
  製品廃止手続き
  同梱資材の調達管理
  海外との品質に関する窓口業務
  業許可の管理（海外及び国内）
  業界及び行政からの調査対応
  法定ラベルのデータ管理
  SDSの作成、管理
  毒劇物取扱責任者
  品質管理に関する教育訓練
  海外品質部門とのコミュニケーション（英文の資料作成含む）
  その他状況に応じて上記に付随する業務
  
  ■働く環境
  条件付きで柔軟にリモート対応可能
  401Kや様々なセミナーなど充実した福利厚生
  
  ━━━━━━━━━━━━━━━#spotlightjob5

  

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  Job number: JN -072024-38866 Posted: 2026-01-28

  Quality Assurance Senior Manager

  Full Remote QA Senior Manager position

  12 - 15 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  The company is a foreign-affiliated pharmaceutical company.

  Responsibilities

  Provide strong support team management for GQP Head on day-to-day basis
  Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
  Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required
  Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
  Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
  Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS
  Perform other duties as assigned such as described below, but are not limited to:
  Provide support for regulatory agency inspection readiness and requests
  Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
  Support business develop
  
  

  

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  Job number: JN -072024-138020 Posted: 2026-01-28

  Medical Doctor - Safety

  1st MD position in the company

  12 - 18 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  Company overview

  We are a global IT services and consulting company that supports business transformation through digital, technology, and consulting services. We provide digital strategy, IT consulting, systems integration, and outsourcing services, aiming to drive industry innovation and efficiency. Additionally, we leverage our global network and advanced technologies to deliver optimal solutions to our clients.

  Responsibilities

  Perform second level triage workflow, review through the entire source document for any potential serious adverse event/s in the case based on conventions
  If the case is serious, then in the activities tab, select the Case level seriousness as Yes
  After the review of the case, document the assessment in the same action item, To be retained as Non-serious OR To be upgraded as Serious with respective rationale and close the action item
  Inform the respective triage associate via email for upgraded case
  Ensuring the ICSR is medically relevant, complete and accurate
  Validation of Seriousness criteria, events captured, coding, labeling, Causality assessment, Writing Company / PV comment. Review and finalize Narratives.
  Generating medically relevant follow-up questions
  Identifying and notifying potential signals
  

  

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  Job number: JN -072024-145164 Posted: 2026-01-28

  Medical Information Specialist/Mangger

  医療業界における顧客対応経験が活かせます。

  6 - 12 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  Company overview

  This company is the world\'s leading pharmaceutical company.

  Responsibilities

  （1）担当する領域の製品、開発品に関する学術的な問い合わせ（電話およびMR経由の依頼）の二次対応（製品情報センターで回答できなかった場合の対応）…文献調査、文献選定、文献内容の要約もしくは関連部署からの情報収集により回答を準備し、電話または文書にて実施（2）問い合わせ対応データから顧客のニーズを判断し、提供用のQ＆A、製品情報センターの口頭回答用のQ&Aを作成、改訂（3）担当する領域の製品に関する顧客からの要望・提案、問い合わせにより生ずるリスクに対し、リスク最小化およびビジネス最大化のための対策を講じる（4）担当製品の関連情報の提供・収集を行い、医療現場における適正使用を確保（5）販売提携などのコ・プロモーション製品においては、提携会社と円滑に情報共有が実施できる体制を構築し、両社における情報提供の整合性を確保（6）グローバルMI担当領域製品チームの一員として下記業務を実施英語での科学的な回答文書（GSRD）の作成、レビューおよびGSRDの日本向けのローカライズを実施
  海外からの英語での問い合わせに対応(文書回答)する。
  （7）GPT（グローバル製品チーム）に参加し、日本のマーケット状況等を共有し、グローバルとしての最適なアクション立案に貢献※専門管理職は上記に加え、マネジメント業務について相応の役割を担っていただきます。

  

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  Job number: JN -072025-191366 Posted: 2026-01-28

  品質管理／品質保証

  GMP、GQPに関する知識をお持ちの方必見です

  6 - 12.99 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  同社は不妊治療等の研究開発を行うバイオベンチャーです。

  Responsibilities

  【採用目的】細胞製品のQC及びQA業務をラボベースからリードできる人材の確保のための募集です。本ポジションでは、細胞製品の品質管理および品質保証業務を担当していただきます。【採用背景及び業務内容】同社はiPS 細胞を利用した生殖補助医療の開発に取り組む会社です。現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定され、そこで同社としてはGMPに準拠した製品供給体制を強化するため、当該パイプラインの開発に関連したQC/QA部門をリードできる人材を募集しています。応募者様のキャリア構築を踏まえいずれはプロジェクト全体のマネジメントや海外を含めたCMOやCDMOとの外部リソースに対するマネジメントなどQC/QAを超えた業務推進もお任せしたいと考えております。

  

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  Job number: JN -072024-5073 Posted: 2026-01-28

  Clinical Trial Manager

  CTM

  8 - 10 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.

  Responsibilities

  臨床試験マネージャーは、治験の開始からデータベース管理まで、臨床業務に従事していただきます。
  臨床試験における様々な側面を管理するマネージャーポジションです。
  他部門との連携が多数発生します（アメリカ拠点との英語コミュニケーション有）。
  定められた目標、タイムライン、予算、および適用される規制要件を順守し、治験の開始から割り当てられたデータベース管理までの臨床試験の運用面を監督します
  

  

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  Job number: JN -072024-6846 Posted: 2026-01-28

  Inexperienced CRA

  Inexperienced

  4.5 - 6.5 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  We are a global leader in biopharmaceutical development based in the United States.
  Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
  Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.

  Responsibilities

  治験を実施する医療機関や医師の選定
  治験の依頼・契約
  治験薬の搬入及び回収
  モニタリング
  GCP、治験実施計画書、SOP に則って治験が進んでいるかを確認
  直接閲覧（SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
  IRB（治験審査委員会）への文書提出及び手続き
  医療機関における保管必須文書が適切に保管されているか確認
  モニタリング報告書作成
  治験の終了手続き 等
  

  

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  Job number: JN -052025-188049 Posted: 2026-01-28

  Account Manager

  Sales incentive: Every quarter+ Annual(5 times per a year)

  5 - 8 million yen Tokyo Pharmaceutical Sales / MR

  ---

  Company overview

  We provide medical and security services, specializing in healthcare, safety, and logistics. Our 24/7 support system spans over 90 countries, ensuring the health and safety of employees worldwide. We offer risk management, emergency support, and consulting services. Our assistance services are delivered by medical and security experts, supporting sustainable business operations by prioritizing employee safety. Our mission is to facilitate safe and sustainable business practices globally.

  Responsibilities

  Manage a portfolio of SME (small/medium) client accounts, either with direct ownership or part of an Account Management Team overseeing a pool of clients, through all stages of the client journey from onboarding, engagement & utilisation, account extension and specifically focused on timely renewal execution as per the defined process.
  Consistently demonstrates an Intermediate level of the following competencies:Develop, manage, and progress a pipeline of renewal and extension opportunities to support successful timely closing and reporting.
  Value and Targeted relationship selling methodology
  Adaptability, creativity, innovative and uses initiative to drive success measures.
  Strategic thinking and critical judgment. 
  Customer orientation (internal and/or external customers).
  Technical knowledge of our services
  Commercial acumen, including the ability to negotiate successfully to protect profitability and increase gross profit
  
  Consistently demonstrates an Intermediate level of the following competencies:Time management, responsiveness, and priority setting
  Verbal, presentational, and written communication skills 
  Self-driven to continue to develop as an Account Management professional
  
  Consistently demonstrates a Proficient level of the following competencies:Teamwork, alongside individual ownership, and action orientated mindset
  
  ━━━━━━━━━━━━━━━

  

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  Job number: JN -072025-191365 Posted: 2026-01-28

  臨床開発やプロジェクトマネジメント

  バイオ医薬品、細胞製品、再生医療等製品での臨床開発またはプロジェクトマネジメントのご経験をお持ちの方必見です

  6 - 12.99 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  同社は不妊治療等の研究開発を行うバイオベンチャーです。

  Responsibilities

  【採用目的】細胞製品上市のために開発をリードできる人材の確保のための募集です。本ポジションでは、細胞製品の臨床開発やプロジェクトマネジメント業務を担当していただきます。【採用背景及び業務内容】同社はiPS 細胞を利用した生殖補助医療の開発に取り組む会社です。現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定されます。そこで同社としては現在、同社の細胞製品の開発を加速し、国内外の規制当局への申請を円滑に進めるため、臨床開発およびプロジェクトマネジメントを担う新たなメンバーを募集します。

  

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  Job number: JN -072024-140855 Posted: 2026-01-28

  Application Scientist

  Pricing and HEOR Hybrid position

  8 - 110 million yen Tokyo Pharmaceutical Research & Development

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  Company overview

  Our client is a life sciences and materials science company.

  Responsibilities

  Provide scientific support to current and prospective customers, which includes demonstrating the optimal use of our life science software suites, facilitating interactions between customers and product development teams, and providing general scientific guidance
  Engage in cutting edge scientific research and provide best practices for modeling automation to our customers
  Consolidate the existing customer base
  Publish scientific papers and present at conferences
  Work from the Tokyo office when not traveling for company business
  

  

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  Job number: JN -072024-137825 Posted: 2026-01-28

  Clinical Trial Leader

  Managing all clinical activities

  12 - 17 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.

  Responsibilities

  Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
  Accountable for oversight of CROs in the execution of Phase I – III global clinical trial(s).
  Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
  Accountable for the successful preparation and presentation of operational content at key governance discussions
  Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team
  Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
  Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
  Accountable for partnering with CRO in audit responses and addressing quality issues.
  Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
  Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
  Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
  Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
  Ensures strong inspection readiness application for all assigned clinical trials.
  Manages a small project or project stream with tasks of low to moderate complexity within a larger project. Leads a small project team with members typically from direct working environment and a straightforward project structure. Coordinates stakeholders from own area or even closely related areas or is partially or even fully responsible for the project’s management within small to medium sized projects. Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
  Accountable for projects within a clearly defined scope and milestones. Receives moderate to low level guidance and direction within broad guidelines.
  

  

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  Job number: JN -072024-138844 Posted: 2026-01-28

  Senior Specialist Quality Assurance / PV Audit

  Global Company

  8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

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  Company overview

  We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

  Responsibilities

  Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
  Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
  Promotes standardization of auditing approach within QA.
  May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
  Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
  Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
  Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
  In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
  In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
  Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
  Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
  Provides inspection management support as appropriate.
  Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
  Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
  

  

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  Job number: JN -072024-137933 Posted: 2026-01-28

  QA Manager

  QA Manager

  10 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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  Company overview

  We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.

  Responsibilities

  Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
  When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
  Ensure full compliance with applicable regulations in Japan.
  Oversee all activities or responsibilities that are delegated to external parties.
  

  

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  Job number: JN -072024-143159 Posted: 2026-01-28

  Medical Affairs PM

  Medical PM

  8 - 14 million yen Tokyo Pharmaceutical Medical Affairs

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  Company overview

  We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

  Responsibilities

  1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
  In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
  In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
  Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
  For US headquarters-led research, work with headquarters personnel to promote the project.
  
  2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
  In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
  Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
  Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
  When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
  After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.
  

  

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  Job number: JN -072024-143741 Posted: 2026-01-28

  Senior Manager Clinical Research

  Global position

  12 - 18 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

  Responsibilities

  Create Japan clinical development plan within global development strategy
  Lead clinical studies in Japan from scientific perspective
  Lead PMDA consultation related to Japan clinical development
  Develop clinical study protocols
  Support development of other study-related materials (e.g. draft Informed Consent, Case Report Form, study related SOP, etc.)
  Support study operations
  Perform medical monitoring of clinical study data
  Develop Clinical Study Reports
  Lead clinical related part of approval review
  Develop clinical sections of the Common Technical Document (CTD)
  Develop responses for clinical related inquiries
  Make presentations at scientific meetings and/or author manuscripts on clinical trials, or provide necessary support for them
  

  

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  Job number: JN -052025-188683 Posted: 2026-01-28

  Regulatory Affairs Specialist

  Tokyo or Osaka OK

  8 - 10 million yen Osaka Pharmaceutical Regulatory Affairs

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  Company overview

  Leading global CRO company
  We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.

  Responsibilities

  Main responsibilities:
  Work related to the preparation, maintenance, and management of clinical trial applications and attached documents
  Various consultations with regulatory authorities (PMDA, MHLW, etc.)
  Work related to approval applications (support for client applications)
  Work related to the collection, maintenance, and management of pharmaceutical information
  Other (participation in various meetings, training, etc.)
  

  

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  Job number: JN -072024-138039 Posted: 2026-01-28

  CRA/Senior CRA

  Both RA and Clinical work

  8 - 11 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC

  Responsibilities

  Clinical Development Operations:
  Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
  Primary point of contact of trial sites with regards to the conduct of the study/ project
  Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
  Ensure that the sites are adequately trained on the protocol and other study specific requirements
  Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
  Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
  Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
  Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
  Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
  Track site budget and payments
  May be involved in preparation of status reports for clients
  Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
  Act as mentor/coach to more junior staff as necessary
  Travel as necessary according to project needs
  Perform other duties as assigned by line manager.
  
  Regulatory:
  
  Ensure study start up processes are done according to applicable SOPs and regulatory requirements.
  Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
  Ensure that product labels are compliant with applicable regulatory requirements
  Collect and submit necessary documents for study drug importation, return and/ or destruction
  Ensure that all documents necessary for site activation are collected
  

  

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  Job number: JN -072024-33887 Posted: 2026-01-28

  Clinical Research Associate/臨床開発モニター(東京・大阪・神戸・在宅可)

  Work on global projects at major CRO

  5 - 10 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  We are a global leader in biopharmaceutical development based in the United States.
  Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
  Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.

  Responsibilities

  具体的には以下のような業務を遂行します。
  治験を実施する医療機関や医師の選定
  治験の依頼・契約
  治験薬の搬入及び回収
  モニタリング ・GCP(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認
  直接閲覧（SDV: Source Data Verification)を実施し、症例報告書（CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収
  IRB (Institutional Review Board)への文書提出及び手続き
  医療機関における保管必須文書が適切に保管されているか確認
  モニタリング報告書作成
  治験の終了手続き など
  
  Specifically, we will carry out the following tasks:
  Selection of medical institutions and doctors to conduct clinical trials
  Making requests and handling contracts
  Delivery and collection of investigational drugs
  Monitoring - Confirming whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
  Performing direct viewing (SDV: Source Data Verification), checking whether the case report form (CRF) matches medical records
  Document submission and procedures to IRB (Institutional Review Board)
  Confirming whether documents required to be kept at medical institutions are stored appropriately.
  Monitoring report creation
  Clinical trial termination procedures
  
   

  

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