• Job number: JN -052025-188683 Posted: 2025-06-16

  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: 2025-06-16

  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 -052025-188049 Posted: 2025-06-14

  Account Manager

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

  5 - 8 million yen Tokyo Pharmaceutical Sales / MR

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  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
  
  ━━━━━━━━━━━━━━━#poweredjob5

  

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• Job number: JN -062025-189647 Posted: 2025-06-12

  研究コンプライアンスリード

  研究施設のリスク管理経験者必見です!

  7 - 12 million yen Kanagawa Pharmaceutical Research & Development

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  Company overview

  We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.

  Responsibilities

  主に以下の業務を想定していますが、応募者の方の専門性や経験に応じて具体的に担当する仕事内容を決定します:
  非臨床試験の品質向上に向けた関連委員会の運営管理と指導
  製品の有効性及び薬物動態に関する非臨床試験の実施のための自社基準に基づくマネジメントシステムの構築と維持・管理
  研究規程の更新と最適化を通じた研究業務の戦略的サポート
  研究倫理の遵守と実験動物の適切な管理や規制物質の取扱い
  問題を洞察し,研究の進捗と品質向上のための解決策の提案
  関係者とのコミュニケーション強化による信頼関係の構築と交渉
  

  

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• Job number: JN -062025-189610 Posted: 2025-06-11

  プロダクトマネジメント

  周囲と協調して仕事を進めた経験がある方必見です。

  5.4 - 8.4 million yen Tokyo Pharmaceutical Marketing

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  Company overview

  We are engaged in the development, manufacturing, and sale of chemical products, offering innovative solutions across a wide range of industries. Our products include functional polymers, synthetic resins, and chemicals, utilized in fields such as automotive, electronics, healthcare, and construction. We prioritize sustainable products and environmental considerations, actively pursuing innovative technologies and research and development. Moreover, we provide customized solutions tailored to our customers\' needs, establishing ourselves as a partner in the industry.

  Responsibilities

  製品情報の集約、整理、資料作成（技術、品質保証、営業などと連携）
  国内、海外メンバーへの製品情報提供、ディスカッション
  薬事、上市、サンプル提供スケジュールの管理と社内共有
  歯科医師、歯科技工士からの情報収集（訪問、展示会、学会参加）
  
  

  

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• Job number: JN -062025-189620 Posted: 2025-06-11

  事業開発

  医薬品、医療機器の研究開発や企画部門でのご経験をお持ちの方必見です

  5.5 - 8.5 million yen Osaka Pharmaceutical Sales / MR

  ---

  Company overview

  同社はＰＥＴやＣＴ、ＭＲＩなどのイメージング技術を駆使し、製薬企業の開発効率化や成功率の上昇に寄与しています。

  Responsibilities

  同社が提供するサービス全般に対する事業開発以下サービス例イメージング技術を活用した医薬品、診断薬、医療機器、バイオマーカーの開発支援
  臨床開発支援（モニタリング、品質管理、イメージング・コアラボ業務、画像解析、読影支援等）
  臨床開発に係るコンサルティング
  プログラム医療機器製造販売業
  

  

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• Job number: JN -072024-142437 Posted: 2025-06-11

  【東京】コマーシャルマネージャー（循環器・メタボリズム・眼科領域）

  製薬会社での業務経験があるご活躍いただけるチャンス

  8 - 12 million yen Tokyo Pharmaceutical Marketing

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  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

  コマーシャルマネージャー／新製品企画（NPP）は、特定の疾患領域（DA）を担当し、パイプラインの「エンド・ツー・エンド」の新規フランチャイズおよび製品戦略を構築する重要な役割を担っていただきます。血栓症、非アルコール性脂肪性肝炎（NASH）などを含む循環器・代謝領域、遺伝性網膜疾患などを含む眼科領域など、複数のDAをリードしていただけることを期待しております。また、戦略的コマーシャル機能の代表として、グローバルおよび地域のステークホルダーとのコミュニケーションの窓口となることが求められます。
  主な職務内容：
  循環器領域、代謝領域、眼科領域の化合物について、研究開発部門とともに化合物戦略を策定
  ラベリング機会の最大化、レギュラトリーパスウェイの加速、パイプラインの優先順位の最適化
  アンメットメディカルニーズとエビデンスギャップの発見
  包括的な市場参入戦略の策定、ローリングビジネスサイクルに沿った予測と予算計画
  診断薬のビジネス価値を関連化合物とともに確立
  ローカルかつリージョンビジネス開発戦略を開発するためのパートナーとなり、BD活動をサポートするための商業的専門知識を提供
  上市チームのリーダーとして、担当化合物の新製品の上市をサポート
  患者の予後を改善するため、テクノロジーを活用したソリューションを実施
  

  

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• Job number: JN -062025-189560 Posted: 2025-06-10

  生物統計業務

  承認申請業務経験をお持ちの方必見です。

  7.54 - 12.84 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.

  Responsibilities

  各開発プロジェクト（国内開発およびグローバル開発）における下記業務生物統計学的観点からの臨床開発計画および臨床試験計画の立案
  臨床試験における統計解析計画の立案および統計解析結果の解釈
  承認申請および照会事項対応における統計解析計画の立案および統計解析結果の解釈
  照会事項対応、主要、副次評価項目等の解析プログラミング（必要に応じて）
  業務を委託する場合、ベンダーの管理、監督
  

  

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• Job number: JN -112024-179086 Posted: 2025-06-10

  Critical Care Business Manager (MR)

  Global leader in specialty pharmaceuticals w/ rich history

  5 - 8.5 million yen Tokyo Pharmaceutical Sales / MR

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  Company overview

  欧州に本社を構えるスペシャリティファーマの日本法人です。

  Responsibilities

  Main responsibilities
  
  Professionally managing assigned territory through the targeting of key customers (physicians, biomedical engineers, nurses and pharmacy).
  Promoting products according to approved product labeling and marketing strategies.
  Conduct financial analysis of accounts and carry out contract negotiations compliant with the procurement processes of the key account and/or Health networks   
  Developing strategic territory management plans to ensure revenue growth with company products.
  Meeting assigned customer promotional reach and frequency goals.
  After hours calls duties for the Customer Care after hours call roster, which is based on a rotational roster amongst the front-line team members. 
  Communicating effectively with specialty physicians. 
  Providing manger timely reports on work hours, sales call data, customer objectives, communications responses and expense reporting.
  Working well without supervision.
  Demonstrating aptitude for learning technical and scientific product-related information.
  Demonstrate a high level of negotiation and influencing skills. Experienced in the contracting and tendering processes within the Japanese hospitals landscape.
  Demonstrate a high level of competency in the analysis and interpretation of sales data and translating the insights and knowledge into executable action plans at the account/territory level.   
  Managing monthly invoicing activities by confirming product hourly usage and receiving hospital confirmation prior to invoicing.
  Successfully managing relationship with partner companies to ensure smooth supply product to hospitals.
  Completing all Post Market Surveillance tasks, such as contracting, CRF collection and reporting, in a timely manner
  Operating within approved budget guidelines
  Providing excellent field communication and direction i.e., emails, voicemails, conference calls, etc…
  Co-ordinating activities with Field Teammates, Internal Teammates, Medical Affairs, Marketing, Customer Care, Finance, Operations and Technical Support.
  Adhering to company policy, procedures and the comprehensive compliance program. 
  
  

  

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• Job number: JN -022025-183819 Posted: 2025-06-09

  PV Manager

  CROのPV部門でのご経験をお持ちの方必見です

  8 - 15 million yen Tokyo Pharmaceutical Pharmacovigilance

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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

  医薬品安全性監視部門（PV）におけるProject ManagementおよびLine Management業務全般をお任せいたします。＜具体的な業務内容＞安全性情報管理（医薬品の臨床試験・市販後）のプロジェクトマネジメント
  Projectの進捗と品質、収益等の管理業務、及び、プロジェクトにおける顧客対応業務。また、他のManagerと連携し、Projectの業務計画と要員計画の立案、業務配分調整やProjectの状況の確認・評価、報告を担当いただきます。要員計画、業務配分、業務の指導など、担当するチーム（10名程度）のLine Management業務
  担当するチームのスキルレベルと生産性の向上、および、働きやすい環境作りをリード。
  担当するチームのメンバーと定期的なコミュニケーションを行い、パフォーマンス評価とキャリア開発。
  グローバルチーム、および、提携企業と協力して、顧客との良好で強い関係を維持。
  

  

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• Job number: JN -062025-189530 Posted: 2025-06-09

  臨床開発（シニアマネジャー）

  Project Lead／Project Managementの経験がある方必見です。

  11 - 14 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  Our client is a global pharmaceutical firm with expertise in researching, manufacturing, and selling regenerative medicine. It stands as a trailblazer in the realm of regenerative medicine, having pioneered a new category of medical solutions. While its core focus is on brain injuries/diseases and central nervous systems, it\'s also actively advancing in the sphere of cancer and neurological disorder treatments.

  Responsibilities

  臨床試験の実施に際し、CRO・ ベンダー・試験実施施設を監督し、リスクを特定して運用上の問題を解決することで試験の進捗をモニタリング
  合意されたスケジュール・予算、および社内標準の品質で試験実施施設の管理とモニタリングに関する全てのアクティビティを主導し管理
  施設選定／被験者募集戦略の立案及び実施
  問題をタイムリーに解決することにより臨床試験データの質を確保
  CROが試験実施施設の管理を実行するためのリスク軽減プランとコンティンジェンシープランの作成と管理
  信頼性保証部門と協力して外部/内部監査に関連する活動をリードし、割り当てられたプロジェクトに関して規制当局の査察対応に貢献
  全ての試験関連文書が最終保管されていること、そしてTMFが完成していることを保証
  試験実施計画書、同意説明文書作成への関与、日本語と英語間の翻訳を保証
  試験の管理に関する課題のエスカレーションを行なうと共に、課題解決に貢献
  臨床開発計画立案及び機構相談資料、試験総括報告書、CTD、照会事項回答作成に関与
  

  

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• Job number: JN -052025-188007 Posted: 2025-06-09

  事業化支援コーディネーター

  医学薬学の知識を有し、製薬企業やライフサイエンス系企業等での実務経験を有する方必見です。

  5 - 6.2 million yen Hyogo Pharmaceutical Marketing

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  Company overview

  Our client promotes innovation in the medical field.

  Responsibilities

  都市の進出企業等に対する事業のライフサイエンス分野（特に創薬・バイオ分野）を支援するコンサルティング
  国内外の企業や研究機関、大学、バイオクラスター等とのネットワーク構築
  再生医療勉強会の運営
  研究開発シーズの実用化・事業化等に関する事業の企画立案等
  

  

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• Job number: JN -062025-189534 Posted: 2025-06-09

  臨床試験プロジェクト

  CRA経験かつClinical Trial Manager (CTM)の経験をお持ちの方必見です

  8.5 - 11 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  Our client is a global pharmaceutical firm with expertise in researching, manufacturing, and selling regenerative medicine. It stands as a trailblazer in the realm of regenerative medicine, having pioneered a new category of medical solutions. While its core focus is on brain injuries/diseases and central nervous systems, it\'s also actively advancing in the sphere of cancer and neurological disorder treatments.

  Responsibilities

  臨床試験の実施に際し、CRO・ ベンダー・試験実施施設を監督し、リスクを特定して運用上の問題を解決することで試験の進捗をモニタリング
  合意されたスケジュール・予算、および社内標準の品質で試験実施施設の管理とモニタリングに関する全てのアクティビティを主導し管理
  施設選定／被験者募集戦略の立案及び実施
  問題をタイムリーに解決することにより臨床試験データの質を確保
  CROが試験実施施設の管理を実行するためのリスク軽減プランとコンティンジェンシープランの作成と管理
  信頼性保証部門と協力して外部/内部監査に関連する活動をリードし、割り当てられたプロジェクトに関して規制当局の査察対応に貢献
  全ての試験関連文書が最終保管されていること、そしてTMFが完成していることを保証
  試験実施計画書、同意説明文書作成への関与、日本語と英語間の翻訳を保証
  試験の管理に関する課題のエスカレーションを行なうと共に、課題解決に貢献
  臨床開発計画立案及び機構相談資料、試験総括報告書、CTD、照会事項回答作成に関与
  
  

  

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• Job number: JN -072024-137931 Posted: 2025-06-09

  Non-Clinical Manager

  1st Non-Clinical Member in Japan

  10 - 12 million yen Tokyo Pharmaceutical Pre-Clinical Trials

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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

  Contribute to the development the strategy from nonclinical perspective.
  Provide / lead the nonclinical-related parts of regulatory documents.
  Interpret the outcomes from studies for clinical and plan/manage appropriate studies.
  

  

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• Job number: JN -062025-189347 Posted: 2025-06-05

  医療機器のマーケティング・商品企画

  マーケティング、商品企画業務の実務経験をお持ちの方必見です

  5 - 10 million yen Tokyo Pharmaceutical Marketing

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  Company overview

  We are a comprehensive heavy machinery manufacturer in Japan, providing machinery and equipment for a wide range of industries. Operating in the petrochemical, steel, energy, transportation, and construction industries, we provide high-quality products and innovative technologies. We provide customized solutions to meet our customers\' needs, helping them improve production efficiency and reduce costs. We also provide maintenance, inspection, and after-sales services to ensure customer peace of mind and satisfaction. With our long history and rich experience, we contribute to industrial development. We continue to focus on quality, reliability, and innovation to support our customers\' success.

  Responsibilities

  医療機器のマーケティング・商品企画業務（1）陽子線、BNCT、核医学における、市場・競合情報収集（2）情報分析と商品企画

  

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• Job number: JN -032025-185859 Posted: 2025-06-05

  早期臨床開発の安全性を担当するメディカルドクター

  非臨床研究の経験者必見です!

  10 - 15 million yen Tokyo Pharmaceutical Medical Doctor

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  Company overview

  We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.

  Responsibilities

  自社開発品の早期臨床開発における安全性管理を担当し、グローバルな医薬品開発に貢献する。
  

  

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• Job number: JN -072024-138020 Posted: 2025-06-05

  Medical Doctor - Safety

  1st MD position in the company

  12 - 18 million yen Tokyo Pharmaceutical Pharmacovigilance

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  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 -072024-38765 Posted: 2025-06-04

  Senior Brand Marketing Manager

  Senior Brand Manager at global mega pharma

  12 - 17 million yen Tokyo Pharmaceutical Marketing

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  Company overview

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

  Responsibilities

  Specific responsibilities of the role include, but are not limited to:
  Develop launch strategy, lead commercial activities for the product
  Understand overall market, an environment surrounded the product and customer insights to develop robust launch strategy.
  Develop tactics based on analysis obtained from data, facts, and insights, and lead commercial activities by leveraging omni-channels
  Implement launch activities by leveraging internal resources and partnerships with third-party vendors, industry organizations, and, if required, other pharmaceutical companies
  Keep eyes open for new information regarding company products, competitors, local and global markets, latest discussions among KOLs and academia, and legislation in Japan
  Lead discussions among global/regional/local colleagues to create launch strategies for product and ensure all the cross-functional colleagues pursue the same goal
  Develop revenue forecasts for the product in consistency with global and regional teams for strategies, assumptions, and models
  Oversee promotional content development and marketing activities for HCPs and consumers, make sure those activities are executed in a compliant manner
  Manage marketing budget and ensure related spends are completed within budget and on time.
  Work with team members through coaching and mentoring;Provide the guidance and coaching to brand managers and other members in the TA as necessary to ensure their success as well as self-growth.
  Create a culture and workplace environment that fosters enthusiasm, collaboration and engagements with peers and team members.
  Uphold and adhere to company policies, compliance rules/regulations, SOPs, and pharmaceutical regulatory guidelines (i.e. cGMP/cGLP/cGCP).
  

  

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• Job number: JN -062025-189175 Posted: 2025-06-03

  【東京】臨床開発プロダクトリーダー

  臨床開発のモニタリング経験者必見です!

  7 - 9 million yen Tokyo Pharmaceutical Clinical Development

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  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

  開発部門では国内外で実施する臨床試験の企画・管理・モニタリングなど様々な業務を行っており，チームで企画からモニタリング業務まで担当します。
  分業制をとっていないのが特徴で、PLはプロダクトチェアーと連携し、プロダクトの開発方針を基に試験実施計画書を立案・作成し、試験実施責任者として試験推進をリードしていただきます。
  ＜具体的に＞治験実施計画書の立案・作成、治験薬概要書（臨床）の作成と改訂
  治験の実施責任者として、臨床チーム（CTL,モニター）およびCROを統括管理
  モニタリングおよび施設対応の実施責任者として、モニターを指揮して治験を実施
  CTL、モニターの指導、教育
  総括報告書の作成、国内申請資料（臨床）の作成
  

  

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• Job number: JN -062025-189190 Posted: 2025-06-03

  統計解析者

  関連ソフトウェア言語の実務知識をお持ちの方必見です

  6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

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  Company overview

  Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
  
  Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies.

  Responsibilities

  フェーズI-IVの臨床試験やBIの経験に基づくプロジェクトを含む複雑な研究/プロジェクトの設計、変換、分析、および報告を担当します。また、特定のユースケースやプロジェクト/資産に関連する臨床薬剤ライフサイクルプロセスからの他のデータ（レジストリや実世界のデータベースなど）の設計、変換、分析、および報告を担当します。
  
  

  

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