• Job number: JN -082025-193078 Posted: 2025-08-25

  国内外製造所管理

  グローバル品目の品質保証及び国内品質保証(GQP)の経験をお持ちの方必見です

  6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

  Responsibilities

  上市済みADC製品の品質マネージメントの推進ADC製品にかかわる、国内外の製造所のCMO管理（CMOにおける変更管理、逸脱等の品質課題対応、品質契約締結等の業務）を行い、品質確保を推進する。各CMOの状況に応じ、CMOの品質向上に向けた改善サポートを実施する。また、各国への申請に対し、製造所に対する各国当局からのGMP査察対応をサポートする。
  

  

  Read more

  Save
• Job number: JN -082025-193070 Posted: 2025-08-25

  QA　ワクチン・再生医療等製品担当

  ワクチン、バイオ医薬品、または新規モダリティ品目の国内品質保証(GQP)の経験が活かせます。

  6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

  Responsibilities

  品質課題対応/変更管理/逸脱/品質情報/品質契約/GMP 監査/製造委託先の Data Integrity 維持・向上等
  製造委託先等管理業務の推進と業務改善
  当局査察の準備推進・製造所の支援
  製造委託先等の GMP 向上支援? 当局提出資料（IND/IMPD、CTD、承認申請書、試験報告書等）の信頼性の確保
  

  

  Read more

  Save
• Job number: JN -072024-143159 Posted: 2025-08-20

  Medical Affairs PM

  Medical PM

  8 - 14 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  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.
  

  

  Read more

  Save
• Job number: JN -082025-192746 Posted: 2025-08-20

  QA　国内外製造所管理（第五グループ）

  国内外当局査察対応経験、新製品の国内外申請業務の経験、製造所の GMP監査経験がある方必見です。

  6 - 10 million yen Kanagawa Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

  Responsibilities

  国内外に展開される商用医薬品・治験薬における品質マネジメント推進
  製造委託先管理業務としての品質課題対応/変更管理/逸脱/品質情報/品質契約等の対応並びにGMP向上のサポート
  海外当局査察にむけた Inspection Readiness の推進・製造所の支援
  当局提出資料(IND/IMPD、CTD、承認申請書、試験報告書等)の信頼性の確保(文書監査)
  海外グループ会社を含めた社内関係各部所と連携し、製品(治験薬及び商用医薬品)安定供給の推進
  製造所等のGMP/GDP監査
  

  

  Read more

  Save
• Job number: JN -072024-137824 Posted: 2025-08-19

  Medical Manager

  Strategy planning and data gathering

  13 - 17 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  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

  STRATEGY:
  Act as Local Medical Affairs TA expert in one or more TAs
  Support the Brand or launch teams/ Local TA leadership team in the development of TA, Launch and Brand strategies
  Lead Medical Affairs activities in assigned territory along defined local Medical Launch / Brand strategies
  Consolidate and communicate trends, market insights, and unmet needs identified in the field
  
  OPERATIONS:
  
  Develop Medical material, review marketing material, trainings
  Ensure scientific and clinical accuracy for specific product or brand
  Receives adverse event reports and transmits such reports internally according to Company procedures
  Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations
  Maintains up-to-date GxP knowledge by following internal and external trainings
  Conduct Local internal scientific training and ensure continuous Medical education of existing teams and new employees working in the Local TA
  Develop Medical KTL development plans
  Positively impact external perceptions and knowledge regarding company and company products
  Maintain and demonstrate comprehensive and in-depth scientific TA knowledge when executing assigned tactics
  Ensure operational excellence by sharing best practices
  Map treatment landscape and medical environment for new indications/ programs
  Provide support in the planning and tracking of the (TA-specific) medical budget
  
  DATA GENERATION AND DISSEMINATION:
  
  Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects
  Lead Local publication process, publication dissemination and alignment with Local, Regional and Global publication plan
  Act as a resource, liaison and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy
   Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites
  Assimilate, process and share medical information with stakeholders
  
  STAKEHOLDER ENGAGEMENT:
  
  Provide training to HCPs and support in realising Medical educational events
  Interact with Local stakeholders in Medical community in TA
  Identify and interact with influential members of the Medical community (HCPs/external experts) and other healthcare stakeholders (managed care organisations, government organisations, patient groups) within assigned territory and TA
  Represent company at Medical Education events, programs, meetings and support patient advocacy related activities
  Partner with external stakeholders to develop innovative solutions
  Engage with internal colleagues (Medical Affairs department, Clinical Operations, Commercial colleagues as appropriate, etc.) in developing and delivering and participating in Medical or cross-functional initiatives
  

  

  Read more

  Save
• Job number: JN -072024-37933 Posted: 2025-08-19

  Specialty Care Medical Affairs Lead

  Medical Affairs Lead position at global mega-pharma

  12 - 22 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  Company overview

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

  Responsibilities

  Leadership of medical team, including setting business objectives, performance management and team development
  Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas
  Recruitment, development and retention of talented colleagues as well as coaching and guidance of colleagues to support them achieving their maximal potential
  Membership of Medical and Commercial Leadership Teams
  Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs
  Ensure compliance of medical team with country Code of Practice and relevant SOPs, regulations and guidelines
  Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications
  Work with key external stakeholders during the life-cycle of the company's medicines, supporting the company strategy and bringing external insights to the organization to shape strategy and providing focused, relevant information in response to their needs
  Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs
  Ensure that product materials and related activities reflect the most up to date regulatory labelling and risk management plans and regulatory commitments
  Input into regulatory submissions, clinical overviews, license variations and CDS updates as required
  Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required
  Input into assessment and due diligence of business development initiatives
  Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio
  Support for in country clinical research programs, including protocol and site feasibilities related to portfolio
  Protocol approval and oversight of in country non-interventional studies related to portfolio
  Support for investigator initiated research (IIR) studies to ensure that appropriate records are kept and progress is monitored
  Support for media, government and patient group activities, including policy development, corporate initiatives and issues management
  Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered
  Accountable for medical team IIR and headcount/expenses budgets
  Represent the country and countries interests to European and Global teams
  

  

  Read more

  Save
• Job number: JN -082025-192639 Posted: 2025-08-18

  【早稲田駅】プラスチック分解プロセス研究※リーダークラス◆経済産業大臣賞受賞スタートアップ

  ディレクターといったマネジメントのポジションに進むことも可能

  6 - 9 million yen Tokyo Pharmaceutical Research & Development

  ---

  Company overview

  微生物のシングルセルゲノム解析技術を用いた受託解析及び共同研究開発

  Responsibilities

  【世界最大級の微生物遺伝子データベース／2022年大学発ベンチャー表彰 経済産業大臣賞】■業務詳細酵素を用いたプラスチック分解プロセスの研究を担当いただきます。実験計画の立案
  微生物培養、遺伝子操作、タンパク質発現・精製、活性アッセイの実施
  データ整理・解析・実験ノート管理
  部内ミーティングでの進捗共有・技術知見のまとめ
  論文・特許・社内及び公的機関への計画書・報告書の作成
  
  ■事業内容食品／化学／素材／ライフサイエンスなどの幅広い産業分野において貢献する酵素技術の開発を行っています。
  〈事例〉
  世界的に関心が高いポリエステル樹脂を分解可能な酵素を同社で開発中です。プラスチック分解酵素をバイオインフォマ技術で探索し、実際に活性が認められた有用な遺伝子の活性向上を実施中です。
  
  ■組織構成研究チームは14名程度で組織されており、平均年齢は30代後半と比較的若く風通しがよく、裁量を持って働ける環境です。研究テーマごとに2～3名のチームを組織しています。
  
  ■評価制度年2回の人事評価を実施しています。昇給 昇格は評価に応じて、年齢や社歴に関係なく実力主義でアップしていくような設計になっています。
  研究者のグレードは5段階あり、ディレクターといったマネジメントのポジションに進むことも可能です。
  
  

  

  Read more

  Save
• Job number: JN -072025-192087 Posted: 2025-08-15

  ライセンシング

  商談可能な英会話力をお持ちの方必見です

  6 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs

  ---

  Company overview

  Our client is a new drug manufacturer.

  Responsibilities

  ライセンス（主にライセンスイン）に関連する業務候補製品、新規プロジェクトの探索
  候補製品、新規プロジェクトの初期評価
  プロジェクトの事業性評価
  提携主要条件交渉、社内外合意形成
  
  海外提携先との窓口業務
  社内関連部門とのプロジェクトのコーディネートと推進※当面は実務業務がメインですが、本人の希望や能力に応じ、将来的にはマネジメント業務も検討可能です。
  
  
  

  

  Read more

  Save
• Job number: JN -052025-188683 Posted: 2025-08-15

  Regulatory Affairs Specialist

  Tokyo or Osaka OK

  8 - 10 million yen Osaka Pharmaceutical Regulatory 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

  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.)
  

  

  Read more

  Save
• Job number: JN -072024-39388 Posted: 2025-08-14

  Pharmacoepidemiology Scientist

  Position at global mega pharma with very strong pipeline

  8 - 14 million yen Tokyo Pharmaceutical Data Management / Biostatistics

  ---

  Company overview

  We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.

  Responsibilities

  Responsible to lead safety observational studies as scientific lead and to deliver deliverables 
  
   Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice) 
   Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective. 
  Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases) 
  Review and develop study report/publications. 
  Lead scientific discussion in cross functional team and in discussion with regulatory agency. 
  Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence. 
  
  Support non-regulatory mandatory safety observational studies
   
  Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies. 
  Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders. 
  
  Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle
   
  Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products. 
  Contribute to Japan Risk Management Plan (RMP) development, periodic report development. 
  Review and develop query response to regulatory authority. 
  Demonstrate knowledge of relevant global and local regulatory requirements and practices 
  Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities. 
  
  Contribute to organizational RWE capability development
   
   Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology. 
  Provide pharmacoepidemiology related trainings. 
  Support system/process development to enhance productivity or increase scientific quality. 
  Obtain up-to-date pharmacoepidemiology approach/knowledge 
  
   

  

  Read more

  Save
• Job number: JN -072024-138848 Posted: 2025-08-14

  Manager, Bio-Statistician

  Global Company

  10 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

  ---

  Company overview

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

  Responsibilities

  Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
  Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
  Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
  Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
  Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
  Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
  Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
  Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
  Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
  Communicate and collaborate with global statisticians on assigned projects.
  Provide a strong statistical presence in regulatory and professional circles.
  Participate in research on statistical methodology and its applications to clinical trials/PMS.
  

  

  Read more

  Save
• Job number: JN -082025-192483 Posted: 2025-08-08

  バイオプロセス初期開発

  抗体医薬品又はその他バイオ医薬品の製造プロセス開発のご経験をお持ちの方必見です

  6 - 10 million yen Gunma Pharmaceutical Research & Development

  ---

  Company overview

  Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

  Responsibilities

  バイオ医薬品（抗体及び抗体関連モダリティ）の製造プロセス開発研究（培養もしくは精製）
  国内外製造場所への技術移転・委託先管理、治験申請のドキュメント作成
  

  

  Read more

  Save
• Job number: JN -052025-187650 Posted: 2025-08-07

  Senior Support Analyst / Lead

  チームワーク／結果へコミットメントする文化

  7 - 10 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

  Main responsibilities:
  Argus: with Good understanding or experience preferred
  Ability to understand and speak Japanese language
  Need Will help liaison and interface with Japanese customers for new and existing projects
  A Configuration expert, capable of handling configuration activities across various customers across the PVCoE.
  Able to contribute across multiple projects.
  Good understanding or experience preferred of Argus Safety system and its configurations and backend along with Argus J.
  Ability to perform SQL/PL-SQL updates to E2B customizations , pre-post save functions , ACs etc.
  In-depth understanding of implementation lifecycle of Safety projects.
  Will help in configuration activities across multiple projects in Safety implementation
  Experience in service delivery management. Deep understanding of ITIL process
  Experience in PostgreSQL
  Understanding of R&d domain and landscape, compliance and regulations
  Stakeholder management, experience in ticket analysis and resolution, problem management. Ability to suggest process improvements and optimizations 
  Independent working and good communication skills
  

  

  Read more

  Save
• Job number: JN -072025-191948 Posted: 2025-07-30

  【茨城】遺伝毒性と発がんリスクに関する研究および評価

  医薬品開発経験者必見です!

  9.1 - 13 million yen Ibaraki Pharmaceutical Research & Development

  ---

  Company overview

  We are a leading pharmaceutical company in Japan, offering a wide range of products in the medical field. Our product lineup includes various pharmaceuticals to support patient health, and we are also dedicated to research and development. We strive to develop new treatment methods and medications to contribute to the treatment and prevention of diseases. Additionally, we operate globally, providing our products to patients worldwide. We uphold high standards of quality and safety, contributing to the advancement of healthcare and the well-being of patients.

  Responsibilities

  遺伝毒性および発がん性のリスク評価を立案、実施し、専門性を活して意思決定を支援します。
  社内プログラムにおいて遺伝毒性の専門家として意見を提言します。
  社内プログラムの円滑な推進に必要な知見を集約し、研究推進を支援します。
  非臨床研究における標的と医薬品モダリティに関する遺伝毒性の懸念に関する情報を提供します。
  ステークホルダーの協力を得て、新しい評価系を構築および実装します。
  必要に応じて社内の非臨床安全性の意思決定会議に、専門家として参加します。
  INDやNDAに関する申請文書を作成し、規制当局を含む社外ステークホルダーとのやり取りをします。
  

  

  Read more

  Save
• Job number: JN -072024-144139 Posted: 2025-07-29

  [Janssen] Contract & Compliance Services, Site Engagement Analyst

  Open to CRO CRA Candidates

  6 - 9 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.
  
  In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.
  
  Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.

  Responsibilities

  Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
  Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
  Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
  Manage the contract amendment lifecycle.
  Assume responsibility for all aspects of legal document and metrics tracking.
  Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
  Comply with requests from QA and auditors.
  Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
  Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
  Exemplary customer focus with vision to drive solutions
  

  

  Read more

  Save
• Job number: JN -062025-189182 Posted: 2025-07-25

  治験薬（製剤）品質保証

  医薬品・医療機器等の企業でのGMP/GQP品質保証業務経験をお持ちの方必見です

  9 - 11 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.

  Responsibilities

  国内外レギュレーションに準拠した治験薬（製剤）の品質保証業務をお任せしていきます。【具体的に】委託先・供給業者監査
  （国内のみに限らず海外対応も含む．海外委託先との会議・実地監査）・品質契約（国内のみに限らず海外対応含む．英文品質契約書の締結）の締結変更管理/異常・逸脱対応/苦情対応/回収/自己点検/マネジメントレビュー対応
  治験薬製造記録及び分析記録の照査/出荷判定
  新薬承認申請資料（CTD及び生データ）の照査
  

  

  Read more

  Save
• Job number: JN -072024-137933 Posted: 2025-07-25

  QA Manager

  QA Manager

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

  ---

  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.
  

  

  Read more

  Save
• Job number: JN -072025-191656 Posted: 2025-07-25

  品質保証・薬事

  医薬品の品質保証業務または薬事業務のご経験をお持ちの方必見です

  5.42 - 6.61 million yen Kanagawa Pharmaceutical Quality Assurance / Quality Control

  ---

  Company overview

  Our client is a trading company specializing in the import and sale of pharmaceutical raw materials.

  Responsibilities

  同社は、ジェネリック医薬品の原薬の輸入・販売を行っている専門商社です。品質保証部では医薬品の品質保証および薬事に関わる業務を担当しています。医薬品業界で培ったGMP／GQP等の専門知識やスキルを大いに活かせるお仕事です。専門知識やスキルをお持ちの方は海外監査等の機会もあります。必要に応じて、社内外での研修や通信教育等をご用意しています。具体的な業務内容:
  適性やご経験に応じて管理グループ・調査グループのいずれかに配属予定です。【管理グループ】（1）品質保証業務: 品質情報、変更管理、供給者管理等（2）薬事業務: 品質取決め締結、製造業・販売業許可等の維持管理（3）海外原薬製造所及び国内製造販売業者への連絡、規制当局への対応等【調査グループ】（1）原薬等登録原簿（MF）の登録・変更、外国製造業者認定の申請・更新、GMP適合性調査手配等（2）（1）の業務に伴う申請準備およびPMDA照会対応（3）（1）の業務に伴う海外原薬製造所及び国内製造販売業者への対応

  

  Read more

  Save
• Job number: JN -072024-145172 Posted: 2025-07-25

  Medical Affairs Review Specialist

  Medical review

  7 - 10 million yen Tokyo Pharmaceutical Medical Affairs

  ---

  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

  資材・スライド等の検証
  社内コンプライアンス研修
  部門横断プロジェクトのリード
  

  

  Read more

  Save
• Job number: JN -072024-138020 Posted: 2025-07-24

  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
  

  

  Read more

  Save