• Job number: JN -092025-193866 Posted: 2025-09-11

  品質保証・統括業務（変更管理）

  製薬業界または関連業界におけるGMP変更管理経験をお持ちの方必見です

  11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

  ---

  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

  GMPに基づく変更管理プロセスの統括・運用管理
  変更管理に関連する評価、承認、文書管理の監督
  クロスファンクショナルチーム（品質保証、製造、エンジニアリング等）との調整・連携
  規制当局対応及び監査対応サポート
  変更管理システムの継続的改善及び教育・トレーニングの実施
  グローバル標準及びローカル規制の遵守確保
  海外拠点やグローバルチームとの定期的な打ち合わせ・調整
  チームマネジメント
  

  

  Read more

  Save
• Job number: JN -092025-193864 Posted: 2025-09-11

  品質保証・統括業務（システム管理）

  CSVに関する実務経験および知識（計画、実施、レビュー含む）をお持ちの方必見です

  11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

  ---

  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

  システム導入プロジェクトにおけるQA視点での規制適合性監視（CSV管理含む）
  CSV（Computerised System Validation）の計画立案、実行、レビュー、報告の監督
  GMP/GxP環境におけるシステム運用監視およびグローバルシステムの管理・調整
  規制要件（FDA 21 CFR Part 11、EU Annex 11等）に基づくシステム管理の指導
  ITチームメンバーのマネジメント（育成、業務割り当て、評価）
  品質保証部門および他部門との連携、グローバルチームとの調整
  内部・外部監査対応のサポートおよび改善活動の推進
  新しい規制動向や技術トレンドのキャッチアップと社内展開
  
  

  

  Read more

  Save
• Job number: JN -092025-193840 Posted: 2025-09-11

  バイオ医薬品の品質保証（査察対応・サプライヤー管理・プロセスエクセレンス・GMP統括/薬制）

  医薬品を世界中の患者様にお届けする貢献と達成感を実感できる!

  11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

  ---

  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

  ■業務内容：GMPに沿った品質保証業務当局査察対応
  自己点検
  サプライヤー管理/サプライヤーAudit
  パートナー会社とのコミュニケーション
  CAPA管理
  品質リスクマネジメント
  高崎工場内の部署横断的な業務推進および関係部署の課題解決支援
  Quality culture醸成活動
  KPI/リスクレジスター管理
  レギュラトリ―インテリジェンス
  承認書維持管理、薬事支援業務
  薬制業務
  その他
  
  ■採用背景：早期退職制度実施後、組織の再構築を現在進めています。その中で、GMP及びOPEXを推進するリーダーが不足しており、GMP/GQPの経験が豊富な人材の採用が不可欠であり、中途採用で即戦力要員を補充したい。
  
  ■ポジションの魅力：グローバルスペシャリティファーマとして発展するKKCの中核となる製造所において、業務プロセスの継続的改善のための活動へ参画するとともに、バイオ医薬品の品質保証業務に関する幅広い経験を積むことができる。最新のPIC/S及びcGMP規制に基づいた品質保証システムを取りまとめる立場として、2027年に米国に竣工予定の製造所の立ち上げ業務に携わり、グローバル生産に関連する品質システムの構築を通じて、グローバルで通用するキャリアを形成できる。自社で開発・製造した医薬品を世界中の患者様にお届けする貢献と達成感を実感できる。
  
  

  

  Read more

  Save
• Job number: JN -092025-193789 Posted: 2025-09-10

  開発・運用担当者

  GxP ITシステムの導入・運用実務経験をお持ちの方必見です

  7 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

  ---

  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

  下記業務の一部を担う。GxP部門横断ITシステムの企画、開発、導入、運用、廃棄における管理業務
  CSV活動の主担当としての計画立案、リスクアセスメント、テスト計画・実施、逸脱管理、報告書作成
  システム開発・運用を委託するITベンダーの管理・コントロール
  ユーザー部門（品質保証、研究開発、製造等）との連携、業務要件の定義、課題解決の支援
  ER/ES指針、データインテグリティ等の最新レギュレーションの動向調査と、社内システムへの適用推進
  CSVに関するSOP（標準作業手順書）や各種手順書の作成、改訂、管理
  

  

  Read more

  Save
• Job number: JN -072024-142446 Posted: 2025-09-08

  医薬品の安全監視策、およびリスク最小化策の立案、実施

  グローバル人材を積極的に採用しております。

  8 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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

  市販薬および治験薬の安全性管理業務（安全性監視計画の立案、安全性評価（シグナル評価）、RMP策定、添付文書改訂など安全確保措置の策定・実施など）
  規制当局との対応業務（承認申請資料作成、定期報告作成、再審査申請資料作成、照会事項、適合性調査など）
  グループ会社担当者（海外含む）と連携した活動（電話会議、メール連絡、海外出張など）
  

  

  Read more

  Save
• Job number: JN -022025-184711 Posted: 2025-09-08

  リスクマネジメントマネジャー

  英語ビジネスレベルをお持ちの方必見です。

  9 - 13 million yen Osaka Pharmaceutical Pharmacovigilance

  ---

  Company overview

  We are a major Japanese pharmaceutical company. We are a pharmaceutical company focused on eye health in particular, and are engaged in the research, development, manufacturing, and marketing of pharmaceuticals in the ophthalmologic field. We are particularly strong in the treatment of dry eye, cataract, and glaucoma, and have earned trust for our high technology and quality. We also have operations around the world and aim to contribute to eye health from a global perspective. In research and development, we are active in introducing new treatments and technologies to meet the various needs related to vision.

  Responsibilities

  集積安全性情報に基づく、シグナルマネジメントの実行と適正使用推進のための企画、リスクマネジメント活動の立案と実行
  製造販売後調査（PMS）の実施計画・解析計画と結果解析、総括報告書作成
  RMP、安全性定期報告、再審査申請資料、ICH-PBRER、DSURの作成、海外現地セイフティーヴィジランス部門の要請に基づくデータ準備
  KOLとの協調による、情報提供資材の発行、論文執筆や学会発表のコーディネート
  外部／内部環境変化に対応したリスクマネジメント体制（システム）の維持更新と運営
  個別症例評価と規制当局報告
  各国規制要件の変更に伴うコンプライアンス体制の維持更新と運営
  

  

  Read more

  Save
• Job number: JN -072024-36491 Posted: 2025-09-08

  ファーマコビジランス

  治験薬に関する包括的な安全対策業務経験がある方必見です。

  6 - 10 million yen Osaka Pharmaceutical Pharmacovigilance

  ---

  Company overview

  We are a global pharmaceutical company that develops, manufactures and globally markets a wide variety of pharmaceutical products. We are particularly strong in the areas of gastrointestinal, cardiovascular, central nervous system, immunology, and other disease areas, providing innovative medical solutions. We promote sustainable medical innovation to improve the health of patients and the quality of healthcare. The company is also committed to social responsibility by focusing on community involvement and sustainable corporate activities. Through aggressive investment in research and development, as well as product development from a global perspective, the company contributes to the advancement of healthcare around the world.

  Responsibilities

  日本における臨床試験に関する安全性業務臨床試験における安全対策立案と関連文書の作成・レビュー
  グローバル開発チームのPV担当との折衝・情報共有
  治験薬に関する安全性評価（個別症例評価ではない）
  治験薬の安全性に関わる文書の作成（治験年次報告書等）
  承認申請における安全対策立案（添付文書「使用上の注意」、RMP等）、審査対応
  
  日本における承認後の安全対策に関する業務市販直後調査
  安全性情報のシグナル／リスク評価・安全対策立案（添付文書「使用上の注意」、RMP等）
  安全性定期報告等の定期報告書の作成
  再審査申請における安全性評価
  
  グローバル安全性評価チームにおける安全性評価、安全対策立案等
  

  

  Read more

  Save
• Job number: JN -072024-4437 Posted: 2025-09-08

  Japan Risk Management Leader

  Rich pipeline, both Clinical and PMS

  9 - 14 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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

  ake full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices and all activities related to Post-Marketing Surveillance/Clinical study/Database research.
  Take full accountability to prepare Re-examination dossier and GPSP compliance inspection in responsible products/compounds.
  Lead and manage PvA and PMSO in responsible products/compounds.
  Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT members.
  As an extended member of Global Safety Management Team(G-SMT), liaise with G-SMT of responsible products/compounds.Join JCoT, NPI and other related committee with license partner companies as a representative for J-SMT of responsible products/compounds and proactively lead safety risk management related discussions and take necessary actions by covering early stage of clinical development though postmarketed phase of products.
  Lead and contribute to the prevention and rapid resolution of local safety risk management related issues including timely stake holder management (internal and external) of responsible products/compounds.
  Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with Group manager/ Director.
  Contribute to the implementation of continuous process improvements from advanced safety management point of view by utilizing latest technologyes while enhance sustainable efficiency in collaboration wih SPMD.
  Understand the rule and principle of the relevant regulations such as PMD Act., GCP, GVP and GPSP and ensure compliance to those regulations, within own responsibility.
  

  

  Read more

  Save
• Job number: JN -072024-142445 Posted: 2025-09-08

  医薬品の安全性管理業務統括（経営職）

  グローバル人材を積極的に採用しております。

  8 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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

  市販薬および治験薬の安全性情報管理業務統括（RMP策定、安全確保措置の策定と管理、開発プロジェクトへの参画及び臨床研究部門との連携など）
  グループ会社担当者（海外含む）と連携した活動（電話会議、メール連絡、海外出張など）
  規制当局との対応業務（定期報告作成責務、再審査申請資料作成責務、照会事項、適合性調査対応業務など）
  

  

  Read more

  Save
• Job number: JN -072024-142042 Posted: 2025-09-08

  Medical Writer

  Global Company

  6 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  Company overview

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

  Responsibilities

  医薬開発部門（Development Japan）において，メディカルライティング（以下MW）を担当する部署として，治験総括報告書（以下CSR），臨床試験成績の公開用文書，コモン･テクニカル･ドキュメント（以下CTD）等の薬事関連文書を各種ガイドラインおよび該当するテンプレートを含むSOP等に準拠して作成/改訂する。また，必要に応じて，それらの文書の公開を行う。
  Japan Medicine Development Team活動を通じて関係者と良好な関係を構築・維持し，Reviewや記述の確認を通じて，スタッフのスキルアップを行うなど質の向上を推進する。
  Global同時開発・申請品目については，Global Medical Writing Groupと協業し，世界共通CTDを作成し，世界各国での承認申請に貢献するとともに米国申請から2ヵ月以内に日本でも承認申請を行う。
  部長およびラインマネジャーを補佐して，グループの活動が円滑に進むように努める。
  

  

  Read more

  Save
• Job number: JN -072024-138844 Posted: 2025-09-08

  Senior Specialist Quality Assurance / PV Audit

  Global Company

  8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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.
  

  

  Read more

  Save
• Job number: JN -082025-192690 Posted: 2025-09-08

  PV職

  製薬に関わるコンサルティング経験やプロジェクト・イネーブルメントもしくはプロジェクトマネジメント業務を経験が活かせます。

  11 - 15 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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

  グローバルPV企画・管理業務
  安全管理業務に関わるBusiness Excellence/プロジェクトの戦略的な計画立案・推進支援
  

  

  Read more

  Save
• Job number: JN -082025-192679 Posted: 2025-09-08

  【東京】PV職（安全対策基盤担当）

  安全対策基盤業務経験者必見です!

  8 - 14 million yen Tokyo Pharmaceutical Pharmacovigilance

  ---

  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

  国内外の関係者と協業したグローバル安全対策基盤業務
  国内外のAggregate Report作成及び管理
  国内RMP資材作成及びグローバル管理
  国内外の安全対策サポート（各種リストメンテナンス、システム導入後のフォロー）
  上記内容に関する運用方針等への参画
  

  

  Read more

  Save
• Job number: JN -092025-193492 Posted: 2025-09-03

  バイオロジー部副部長候補

  大学院 博士後期課程修了(ドクター)卒の方必見です

  9 - 12 million yen Kanagawa Pharmaceutical Research & Development

  ---

  Company overview

  Our Client is engaged in the research and development of RNA-targeted small-molecule drugs.

  Responsibilities

  RNAを標的とした低分子医薬品の創薬研究（医学・薬理学・生物学・生化学が中心）新規創薬標的の探索・提案
  ヒット／リード化合物の価値最大化（メカニズム分析・PoC／PoM／PoP検証など）
  化合物スクリーニング
  
  年度研究計画策定、実行
  マネジメント（正社員・派遣社員）
  担当役員への報告・連絡・相談
  
  

  

  Read more

  Save
• Job number: JN -072024-38609 Posted: 2025-09-02

  品質保証

  大手外資系ファーマでの次世代ポテンシャル採用

  6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control

  ---

  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

  Overall Job Purpose:
  西神製造所における医薬品／医療機器製造工程、製品試験に関する製品品質保証業務
  Job Responsibilities:
  新製品導入に伴うGMP対応、品質保証システムの構築、社内関係部門との調整（社内の国内、海外関連部門と協働し、GQP, GMPに基づく製造所としての品質基準、保証システムを構築）
  国内販売製品の製造所としての品質管理（製造および試験記録照査、逸脱、変更、バリデーション管理）
  品質情報及び品質不良等としての調査、報告業務
  製造所における監査対応業務、出荷判定業務
  社内の海外製造所との品質改善活動
  
  

  

  Read more

  Save
• Job number: JN -092025-193371 Posted: 2025-09-01

  主任研究員

  顧客/代理店/技術スタッフとプロジェクトの調整を行うことができる方必見です

  5.4 - 7.2 million yen Aichi Pharmaceutical Research & Development

  ---

  Company overview

  Our client is a university-based venture company.

  Responsibilities

  業務内容:
  シングルセルテクノロジーと無細胞タンパク質合成系を組み合わせた独自技術を用いた、モノクローナル抗体探索の受託事業における、実験実務、プロジェクト管理・顧客対応、技術営業をお任せします。また閑散期には社内プロジェクトの研究開発にも携わります。業務詳細:
  割合としては実験実務がメインで5～6割程度、プロジェクト管理・顧客対応が2割程度、技術営業が2割程度です。技術営業では、同社への委託を検討中の顧客に対しての詳細な技術説明や、具体的な案件に関して技術面での協議を進めます。

  

  Read more

  Save
• Job number: JN -072024-33887 Posted: 2025-09-01

  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

  ---

  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
  
   

  

  Read more

  Save
• Job number: JN -072024-143282 Posted: 2025-08-29

  [Osaka or Tokyo] Clinical Team Manager

  Strong Global Foot Print and High Salary

  9 - 15 million yen Tokyo Pharmaceutical Clinical Development

  ---

  Company overview

  Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
  We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.
  
  As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
  We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.

  Responsibilities

  BUILD RELATIONSHIPS WITH CLIENTS AND LEAD
  PROJECTS BY COLLABORATING WITH PROJECT MANAGER (GLOBAL PM OR REGIONAL / LOCAL PM) AND OTHER DEPARTMENTS (INCLUDING PARTNER VENDORS) AS NEEDED -CRA FOR EACH PROJECT, IN-HOUSE CRA, PROJECT LEADS SUCH AS CONTRACTS ASSOCIATE AND START-UP LEAD
  MANAGEMENT OF QUALITY, TIMELINE, AND BUDGET IN MONITORING
  PROACTIVE RISK MANAGEMENT
  CONTRIBUTING TO GROWTH WITH APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS
  

  

  Read more

  Save
• Job number: JN -082025-193322 Posted: 2025-08-29

  開発企画部

  医薬品業界でのご経験の方必見です

  5 - 7 million yen Tokyo Pharmaceutical Regulatory Affairs

  ---

  Company overview

  Our client primarily manufactures and sells prescription pharmaceuticals and in-vitro diagnostic reagents.

  Responsibilities

  CMC担当者として、同社製品の開発に関するCMC戦略の立案及び承認申請業務を担っていただきます。製造及び試験手順の理解に基づくCTD作成（主にCMC）、及び紹介対応
  海外の関係会社/研究機関との協業における資料提出期限や品質の確保
  海外の関係会社/研究機関とのコミュニケーション（医薬品の海外導出）
  DMFの作成、変更対応
  

  

  Read more

  Save
• Job number: JN -082025-193087 Posted: 2025-08-25

  CMC薬事担当

  バイオ医薬品・ワクチンのグローバル申請・承認取得・変更申請に従事したご経験をお持ちの方必見です

  6 - 10 million yen Tokyo Pharmaceutical Regulatory Affairs

  ---

  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

  医薬品の開発段階から承認取得、さらに市販後変更管理に渡る関するグローバルCMC薬事戦略の立案と日本・アジア・太平洋地域におけるCMC薬事業務の推進、資料作成、当局対応、等の業務全般を担当する（実際に担当いただく業務は、採用決定後に配属グループ内で調整し決定される）。 実務のリーダー的役割を担い担当業務を推し進める。複雑な課題に対して専門知識を活かして自律的に解決方法を検討し、実務経験や前例も考慮した判断を行う。複雑な情報を明確に説明し、困難な状況でも合意形成を図りながら、与えられた裁量を最大限に活用し、チームの成果を最大化する。 社内業務プロセスの改善点を特定・提案しながら問題解決や効率化を図る。業務を通じて高い組織成果の創出と後進の育成に貢献し、プロフェッショナルとしての自らの成長を組織の成長に活かす。

  

  Read more

  Save