Jobs list of Pharmaceutical
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NEWJob number: JN -122024-182077 Posted: 2025-08-15
【京都・長岡京】保健士（安全衛生 健康管理スタッフ）◆在宅勤務・フレックスタイム制度有／年休127日
働きやすさ◎＜年休127日・土日祝休・フレックス有5 - 10 million yen Kyoto Pharmaceutical Nurse
- Company overview
- This company is a semiconductor manufacturer.
- Responsibilities
- ■具体的な仕事内容：健康管理室としての産業保健業務を担当いただきます。健康診断、面接指導等の実施及びその結果に基づく労働者の健康を保持するための措置、作業環境の維持や作業管理等の労働者の健康管理に関する指導業務
健康相談やその他労働者の健康の保持増進を図るための措置に関する業務
労働衛生教育や健康教育、健康障害の原因の調査及び再発防止のための措置に関連する内容の業務
健康管理上必要な従業員の情報管理を人事部門と連携し、各種健康診断対象者の選定及び組織管理者展開への支援業務
Martin Tsvetkov
Industrial & Life Science -
NEWJob 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。
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -052025-188683 Posted: 2025-08-15
Regulatory Affairs Specialist
Tokyo or Osaka OK8 - 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.)
Elaine Montes
Industrial & Life Science -
NEWJob number: JN -082025-192438 Posted: 2025-08-15
CMC薬事担当者
新規医薬品の承認申請対応や当局相談を含む品質パート薬事対応のご経験をお持ちの方必見です6.55 - 12.97 million yen Tokyo Pharmaceutical Regulatory Affairs
- 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
- 細胞遺伝子治療における国内開発品の品質パート薬事戦略立案、当局相談、申請及び審査対応の実施。
細胞遺伝子治療における海外関連会社との協働。
バイオ医薬品・再生医療等製品・化成品に関する開発品の品質パート薬事戦略立案、並びに国内当局相談、申請及び審査対応の実施。
市販後製品の品質パートの国内薬事戦略立案、当局相談、申請及び審査対応の実施。
輸出品に対しての海外関係会社とのコミュニケーション、連携。
グローバル各国申請における、各国申請薬事担当との協働。
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -082025-192593 Posted: 2025-08-14
プログラムアナリスト
安全性データベース関連業務経験5年以上をお持ちの方必見です5 - 9 million yen Tokyo Pharmaceutical Pharmacovigilance
- 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
- 安全性DBに関連するエンドユーザーの質問を解決
定期的な辞書の更新をサポート
PV安全性DBベンダーと連携し、システムのアップグレード、機能強化、問題解決
PPD Change Controlポリシーに基づき構成の変更やシステムのアップグレードなど、PV安全性DBへの変更を管理
組み込みツール、OBIEE/SQLを使用し、PV安全性DBからカスタム/アドホックレポートを作成
集積安全性レポートを作成及び検証
PV安全性DBのSOP開発/PV安全性DBの内部および外部監査をサポート
PV安全性DB内に新しいテナントを作成/Distribution Rule Configurationsを開発
データ移管計画、設計仕様、概要レポートの作成を含むデータ移管および検証PJを主導し、データ移管活動が要件を満たし、完全、正確であり、高品質で提供されることを確認
事業の成果や業界のコンプライアンス要件をサポートする為、製品やサービスの開発と提供を組織、調整、文書化し、世界中の部門を超えた徴収に提供する準備をするためイニシアチブのリーダーや経営陣と協力
部門の任務と戦略をサポートするためのサポート資料、プレゼンテーション、ツールを開発
プロセス、システム/アプリケーション、トレーニング、コミュニケーションを開発、最適化、改善するため、イニシアチブのリーダーや経営陣と協力
プロセス改善開発・プロセス改善の取り組みを主導
プロセスの遵守状況を評価しビジネスプロセス改善のニーズに優先順位をつけるために必要な情報を特定し、照合
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -072024-39388 Posted: 2025-08-14
Pharmacoepidemiology Scientist
Position at global mega pharma with very strong pipeline8 - 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
Yui Osone
Industrial & Life Science -
NEWJob number: JN -072024-138848 Posted: 2025-08-14
Manager, Bio-Statistician
Global Company10 - 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.
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -082025-192515 Posted: 2025-08-12
【中央区】プロダクトマネージャー オンコロジー・免疫学
製薬マーケティング経験者必見です!7 - 9 million yen Tokyo Pharmaceutical Marketing
- Company overview
- We have been contributing to the improvement of patient welfare and access to healthcare by offering innovative biologics to the world.
- Responsibilities
- 会社方針に則った年次及び中期戦略と戦術を立案実行し、新たなビジネスモデルを構築する
マーケティングミックスの構築と売上最大化のための施策を実行する
利益最大化のために適切なOPEXを意識し、実行する
戦略・戦術の実行の過程で適時、市場分析/業績分析/利益管理を行い柔軟に計画の修正を行う
またこれらを通じ、プロダクト ライフサイクルマネジメントを行う・Global方針を理解し、Globalメンバーとの協業を行う
関連部署との相互理解とRespectに基づいたCommunicationを実施し、協業を推進する
学会イベント実施やPR資材作成を通じ、KOL育成を行う
社外Stakeholderへのアライアンス対応を行う
マーケティング部のエビデンス構築活動に対するサポートを実施する
開発部とともに新製品上市を行う
マーケティング部とともに経営メンバーへの戦略・戦術進捗報告や新たな提案を行う
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -082025-192532 Posted: 2025-08-12
CMCプロジェクトマネジメント
医薬品の原薬製造技術、製剤製造技術において専門的知識をお持ちの方必見です7.66 - 12.97 million yen Tokyo Pharmaceutical Clinical Development
- 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
- CMC開発部門におけるバイオ医薬品のプロジェクトチームのマネジメント（開発/上市プロジェクトのLCMを含むCMC開発戦略・計画策定とCMC関連部門の調整）
国内外の治験薬・商用生産体制の構築および治験薬・製品供給計画の策定と実行
CMC戦略、薬事規制等の情報収集及び発信
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -082025-192519 Posted: 2025-08-12
PV担当（一般職）◆LS関連業務
医療用医薬品に関する副作用DB（LS、Argus等々）の3年以上の運用経験が活かせます。5.27 - 7.13 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- Our client is in the pharmaceutical manufacturing.
- Responsibilities
- LS関連LSのベンダーであるAris Global社／Nextrove社との窓口業務
システムのVersion upやMedDRA/J DrugのVersion up等の対応業務
他社からの医療用医薬品承継時におけるDB移行業務（現時点で確定している承継品はありません）
LSユーザー（安全性情報部/CRO）に対するヘルプデスク対応支援業務
GVP関連業務記録の保存、社に教育訓練等々を含めるが、応相談。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192485 Posted: 2025-08-08
供給マネジメント担当者
製薬企業等で治験薬供給マネジメント業務のご経験をお持ちの方必見です6 - 10 million yen Tokyo Pharmaceutical Clinical 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
- 治験薬供給マネジメント
（臨床試験向け供給計画調整、治験薬製造施設との製造計画調整（製造委託先との調整を含む）、治験薬保管・配送戦略立案と実行管理等）
Martin Tsvetkov
Industrial & Life Science -
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
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-191956 Posted: 2025-08-07
研究開発型製薬メーカーにおける造血幹細胞遺伝子治療に関する研究基盤業務／経営職
細胞やウイルスの製造やプロセス開発の経験,が活かせます。11.25 - 12.97 million yen Tokyo Pharmaceutical Research & Development
- 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
- 遺伝子・細胞療法に関する開発候補物質の創製
遺伝子・細胞療法に関する研究基盤テーマの立案及び遂行
幹細胞研究を通じた標的探索や疾患解明研究
外部との共同研究の推進や外部技術の評価
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192274 Posted: 2025-08-07
免疫研究者
免疫学に関連した探索研究のご経験をお持ちの方必見です7 - 12 million yen Kanagawa Pharmaceutical Research & Development
- 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
- 免疫学と分子細胞生物学の深い知見に基づき，プロジェクトの非臨床安全性研究を推進する。主として各種のin vitroツールを駆使しながら，安全性に関する課題を特定し，解決策の立案・実行を牽引することで，プロジェクト意思決定と画期的な新薬の創出に貢献する。
医薬品の安全性とヒト予測性の向上に向け，毒性発現メカニズムの解明，新規in vitro評価モデルの構築，新たなバイオマーカーの探索と検証等の先端研究をリードする。
国内外の研究者やビジネスパートナーと連携したグローバルな視点での研究開発を加速させる。
Martin Tsvetkov
Industrial & Life Science -
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
Elaine Montes
Industrial & Life Science -
Job number: JN -082025-192325 Posted: 2025-08-06
CPL+MA（心不全・CKD領域）
臨床試験／臨床開発に関連する規制に関する知識をお持ちの方必見です6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development
- 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
- CDP/AEP：アセットのCDP（臨床開発計画）を評価、提案、実行します。
アセットのAEP（アセットエビデンス計画）が日本のニーズ（現地の医療／競争状況および差別化を含むがこれに限定されない）を統合し、グローバルアセット戦略と一致していることを確認します。これは日本およびコーポレートアセットチームによって合意されています。
J-NDA & 登録：コアエビデンスチームのメンバーとして、割り当てられたアセットの提出および登録をサポートします。
J-CTD臨床概要を作成し、科学的レビューアーとしてCTDモジュール2を監督します。
承認が得られるまでのJ-NDA審査期間中に、臨床部分に関連するPMDAの問い合わせ対応をリードします。等
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-188049 Posted: 2025-08-05
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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Elaine Montes
Industrial & Life Science -
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。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-191966 Posted: 2025-07-30
グローバルプロジェクトマネジメント業務
新薬の開発経験をお持ちの方必見です7.66 - 12.97 million yen Tokyo Pharmaceutical Clinical Development
- 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
- 開発プロジェクトのプロジェクトマネジメント業務下記の活動を通じてプロジェクトを計画通り推進する。開発プロジェクトチームの主要なインテグレーターとして、プロジェクトマネジメントツールおよびテクニックを活用し、チームビルディングとチームのモチベーションを向上させるリーダーシップスキルを発揮する。
さまざまな開発相にわたる開発プロジェクトを組織の目標とスケジュールに沿うように管理する。
包括的なプロジェクト予算とリソースを作成し、モニタリングする
チームと協力して統合されたプロジェクトタイムラインを作成し、進捗をモニタリングし、必要に応じて変更を施す
潜在的なリスクを事前に特定し、リスク緩和策を策定、実行する。
部門、チーム、地域を越えて効果的にコミュニケーションを取り、プロジェクトを推進する。主要な文書の管理、透明性の確保、教訓やベストプラクティスの共有により、チームのパフォーマンスを最適化し、組織内のプロセス改善を促進する。
組織の要求事項に対応し、ガバナンス会議、承認プロセス、部門間の連携などを含め、プロジェクトを円滑に進め、管理する。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-144139 Posted: 2025-07-29
[Janssen] Contract & Compliance Services, Site Engagement Analyst
Open to CRO CRA Candidates6 - 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
Patrick Chang
Industrial & Life Science