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  • Job number: JN -072024-38471 Posted: 2024-10-02

    製品品質保証

    Quality position at mega pharma with strong pipeline
    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
    医薬品、医療機器、コンビネーション製品の国内及び海外製造所等における適正な品質管理の確保
    新製品及び既承認品目の承認取得、維持のため、PMDA等による関連製造所へのGMP/QMS適合性調査の対応
    製造販売業者の許可取得、維持のための品質確保業務(当局査察の対応を含む)
    適用される規制要件及び社内コーポレート基準に従った社内基準の確立並びに維持管理
    製造業者、アライアンスパートナー等との取決めの締結並びに維持管理
    製造業者、販売業者、社内関係部門及び社内コーポレートとの連携にもとづくGQP/QMS品質保証業務(逸脱、苦情、変更、出荷判定等)の実施
    顧客満足の実現を目的とする、製造業者を含む継続的な品質改善活動の指導及び推進
    新製品の上市及び既承認品目の承認維持のためのGMP/QMS調査の対応
    苦情管理チームとの連携による顧客問い合わせへの回答
    Yui Osone
    Yui Osone
    Industrial & Life Science
  • Job number: JN -072024-38610 Posted: 2024-10-02

    品質システム コンプライアンス

    大手外資系Qualityポジション
    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
    文書管理システムの運用及び管理
    文書管理責任者(又は文書管理担当者)
    文書及び記録の保管と管理(GMP Library、GQP/QMS Archive
    GMP/QMS/GQP/GDP 上の基本的な文書(GMP/QMS/GQP 総則、手順書類)の維持
    手順書類の制定及びメンテナンス、及びこれらに関する他部署へのサポート
    署名の管理

    トレーニングシステムの運用教育訓練責任者(又は教育訓練担当者)
    年間教育訓練計画の作成、実施及び/又はサポート
    トレーニングカリキュラムの維持
    各業務エリアにおける認定の実施と維持
    文書・教育に関連する 社内スタンダード 、Global Quality Standards (GQS) のギャップアセスメント及び対策検討
    文書管理システム、及びトレーニングシステムをサポートするためのコンピュータシステム の運用管理Success Factors のデータ管理
    文書管理システムの運用・管理、及び適正な運用のための指導(文書管理システム 管理責任者/文書管理システムワークフロー管理者)
    社内ののデータ・サイト管理
    QSC 内でのトレーニング&文書管理関連業務が円滑に行えるよう、担当者の管理を行う。
    Yui Osone
    Yui Osone
    Industrial & Life Science
  • Job number: JN -072024-37534 Posted: 2024-10-02

    Project Statistician

    Global mega-pharma with strong pipeline
    5.5 - 7 million yen Hyogo 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
    Responsibilities:
    The Project statistician provides strong statistical leadership in the process of drug development, develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is also responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

    Other Responsibilities Include But Not Limited To The Following
    Statistical Trial Design and Analysis
    Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
    Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
    Collaborate with data management in the planning and implementation of data quality assurance plans.
    Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
    Participate in peer-review work products from other statistical colleagues.

    Communication of Results and Inferences
    Collaborate with team members to write reports and communicate results.
    Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
    Respond to regulatory queries and to interact with regulators.
    Therapeutic Area Knowledge
    Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
    Regulatory Compliance
    Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
    Statistical leadership and Teamwork
    Introduce and apply innovative methodology and tools to solve critical problems.
    Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
    Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
    Yui Osone
    Yui Osone
    Industrial & Life Science
  • Job number: JN -072024-144533 Posted: 2024-10-02

    [Osaka] Experienced CRA (including Sr./Pri.)

    Global Pipeline with Work Life Balance
    4 - 10 million yen Osaka Pharmaceutical Clinical Development

    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
    Work to confirm (monitor) whether clinical trials are conducted in accordance with relevant laws and regulations (GCP) and implementation plans (protocols) at appropriate medical institutions under consignment from clients, and whether the human rights and safety of subjects are protected is. Selection of medical institutions and doctors in charge of conducting clinical trials
    Confirmation of clinical trial schedule and contract details, and implementation of briefing sessions for medical institution staff
    Clinical trial progress management: Progress management of the number of cases, collection / inspection of case report reports, collation of case report reports with materials
    Delivery of investigational drug, confirmation of supply management status, collection
    Preparation of monitoring report
    Clinical trial completion procedure, confirmation work
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-29511 Posted: 2024-10-02

    【東京】海外マーケティング担当

    プロジェクトマネジメントがある方必見です。
    6 - 8 million yen Tokyo Pharmaceutical Marketing

    Company overview
    We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
    Responsibilities
    マーケティング調査・分析に基づく成長戦略立案。
    グローバル市場をスコープとした販売体制強化のための提携交渉、海外拠点の組織構造改革の推進。
    新商品企画プロジェクトにおいて、開発、薬事、臨床開発、デザイン、品質保証、提携先、海外拠点など様々なステークホルダーを取りまとめながら、マーケティング戦略のインプリメンテーションとプロジェクトマネジメントを実行。
    特に中国や東南アジアの成長機会を捉えるため、医療機関攻略だけでなく、リテール(OTC)向けのマーケティング・プロモーション戦略の立案と実行力があることが望まれる。
    Shotaro Tsubaki
    Shotaro Tsubaki
    Industrial & Life Science
  • Job number: JN -072024-37400 Posted: 2024-10-02

    品質管理部 SQC Operator

    Opportunity to work at global maker with strong pipeline
    5 - 7 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
    注射剤及び固形製剤の品質管理、分析試験業務(理化学試験、微生物試験)、製品規格試験の実施及びそれに関わるverification
    品質管理に係る手順、記録等の作成及び照査
    上司と共に逸脱・トラブルに対する調査及び問題解決を行う
    上司と共に変更管理を実行する
    部内における業務品質及び生産性改善活動
    グローバル・ローカルプロジェクトへメンバーとしてサポート
    その他試験実施に関わる管理業務
    Yui Osone
    Yui Osone
    Industrial & Life Science
  • Job number: JN -072024-38609 Posted: 2024-10-01

    品質保証 次世代ポテンシャル採用

    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

    Yui Osone
    Yui Osone
    Industrial & Life Science
  • Job number: JN -072024-25962 Posted: 2024-09-25

    医薬品探索研究職

    グローバルに活躍
    5.93 - 9.78 million yen Shizuoka Pharmaceutical Research & Development

    Company overview
    We specialize in the research, development and manufacture of pharmaceutical products. We mainly provide therapeutic drugs for diseases of the cardiovascular system, bone and joint system, and nervous system, with the aim of improving the health and quality of life of patients. We are committed to creating new drugs and improving existing drugs by utilizing our advanced technological and R&D capabilities. We also set strict standards for product quality control to supply safe and effective medicines to the market. In collaboration with medical and research institutions in Japan and overseas, we also focus on developing treatments that incorporate cutting-edge medical technologies. With an emphasis on a patient-centered approach, we have established ourselves as a trusted pharmaceutical manufacturer.
    Responsibilities
    蛋白質の機能解析、構造解析研究(X線結晶構造解析、CryoEM)を中心とした医薬品探索
    蛋白質発現、精製、構造解析、化合物との相互作用解析手法の立案および試験の実施
    構造解析や相互作用解析を中心とした新規創薬技術の調査、検討、立案
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-34410 Posted: 2024-09-25

    【静岡/浜松市】研究開発◆眼科治療機器IOL(眼内レンズ)・挿入器

    光学製品の設計開発を実施した経験者必見です!
    5 - 8 million yen Shizuoka Pharmaceutical Research & Development

    Company overview
    Our client is a Japanese general trading company.
    Responsibilities
    IOL(眼内レンズ)及び挿入器の研究開発(素材設計、光学設計、機械設計等)
    加工技術開発
    研究開発品の設計管理
    製品仕様の策定、技術移管
    知的財産関連の情報整理
    QMS維持管理業務
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-36491 Posted: 2024-09-25

    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
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-169609 Posted: 2024-09-25

    医薬品分析の委託試験窓口担当者 (プロジェクトマネージャ)

    医薬品に関するCMC分析分野での経験をお持ちの方必見です。
    5 - 8 million yen Kyoto Pharmaceutical Research & Development

    Company overview
    Our client provides solutions from R&D to production for pharmaceutical products.
    Responsibilities
    主に医療用医薬品(低分子/バイオ医薬品の原薬・製剤)の分析に関するお客様からの発注内容に基づき、窓口として社内外の業務調整を行います。また、営業をサポートして発注前の依頼内容の相談にも対応します。 顧客との打ち合せ、問い合せ対応(Web会議、対面会議、電子メール、電話対応など)
    試験に必要な書類の作成(品質(出荷、受入)試験の成績書,安定性試験・開発試験法・分析法バリデーションの計画書/報告書、社内への指図書)
    試験担当部門との業務調整
    受託試験の進捗把握・管理
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-30558 Posted: 2024-09-25

    【茨城】抗体等高分子医薬品の分析並びに薬物動態研究担当

    高分子医薬品の生体試料分析の実務経験者必見です!
    5.4 - 10 million yen Ibaraki Pharmaceutical Research & Development

    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
    抗体薬物複合体(ADC)及び抗薬物抗体(ADA)の分析法構築、バリデーション試験及び濃度測定の対応(ICH M10等のガイドライン対応)
    Ligand binding assay(LBA) Working Group(WG)のリーダー業務及びLBAに関する所員の育成指導  
    抗体薬物複合体(ADC)の創薬スクリーニング分析及び評価
    創薬テーマの低分子化合物の濃度測定及びPK解析の実施
    抗体薬物複合体の創薬テーマ窓口業務 
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-38296 Posted: 2024-09-25

    低分子プロセス化学研究リーダー

    CROにおけるプロセス化学研究の業務経験5年以上お持ちの方必見です。
    5.6 - 8.6 million yen Ibaraki Pharmaceutical Research & Development

    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
    リーダーとして、低分子医薬候補の開発加速化を目指したプロセス化学研究の牽引をご担当いただきます。創薬研究部門における初期プロセス化学研究の牽引
    創薬研究部門における開発候補化合物の初期プロセス開発
    CMC部門及び各種原薬や中間体製造委託先への製造技術の情報移管
    初期プロセス研究効率化のための各種情報収集、技術獲得 
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-145700 Posted: 2024-09-25

    【群馬】製剤・技術開発※課長候補

    製剤開発および技術の実務経験5年以上お持ちの方必見です。
    7 - 7.5 million yen Gunma Pharmaceutical Regulatory Affairs

    Company overview
    A major pharmaceutical manufacturer.
    Responsibilities
    当社の製剤開発・技術部門課長候補として、製剤(CMC)関連業務全般をご担当いただきます。医療用医薬品の製剤開発
    市販用(OTC)医薬品の製剤開発
    左記の申請対応業務
    動物薬の製剤開発
    食品、動物用飼料の開発
    上記全般の生産部門へのスケールアップ、技術移管など生産移行対応
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-168812 Posted: 2024-09-25

    【岐阜】開発製剤の分析技術開発、その品質管理戦略に精通した製剤分析研究員

    製剤の分析法開発経験者必見です!
    7 - 9.5 million yen Gifu Pharmaceutical Research & Development

    Company overview
    We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
    Responsibilities
    製剤の各種分析法の開発、安定性試験の実施、品質管理戦略の立案
    自社および委託先など国内外試験サイトへの試験法の移管、或いは技術的指導
    Globalでの申請戦略の立案と申請資料の作成、照会事項回答、および査察などの当局対応
    多様なモダリティ製剤(経口固形、抗体、ADC)の物性研究や新規分析法の研究、技術開発 
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-168813 Posted: 2024-09-25

    【岐阜】注射剤開発に精通した製剤研究者

    バイオ医薬品の開発経験者必見です!
    7 - 9.5 million yen Gifu Pharmaceutical Research & Development

    Company overview
    We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
    Responsibilities
    注射剤の処方設計および製造プロセス開発
    注射剤の治験薬製造(自社、もしくは国内外のCMO)
    臨床試験に関する申請資料の作成(IND、IMPD、CTNなど)
    国内および海外のCMOでの製造プロセスの最適化および商業生産立ち上げ
    申請戦略の立案と申請資料の作成(NDA、BLA、MAA、J-NDAなど)および当局照会事項対応
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-168814 Posted: 2024-09-25

    原薬研究者

    医薬品プロセス開発の経験とスキルをお持ちの方必見です。
    7 - 9.5 million yen Ibaraki Pharmaceutical Research & Development

    Company overview
    We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
    Responsibilities
    治験用原薬の製法開発(低分子、ADC(Antibody Drug Conjugate)等各種モダリティの新規医薬品候補化合物の製造法の探索、スケールアップ研究)
    商業生産製法に向けた製造プロセスの最終化と品質管理戦略策定、サポートデータ取得、申請書作成
    自社、委託先の国内外研究、製造サイトへの技術移管、マネジメント
    新規製造法、新規モダリティ関連の技術獲得
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-168817 Posted: 2024-09-25

    非臨床安全性研究者

    非臨床安全性試験の立案、実施、評価の経験をお持ちの方必見です。
    7 - 9.5 million yen Ibaraki Pharmaceutical Research & Development

    Company overview
    We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
    Responsibilities
    各種細胞、動物を用いた非臨床安全性に関する実験、試験の実施その報告書作成(英文)
    NGS、Single cell analysis含むオミクスデータの解析、安全性評価への応用。
    探索、体内動態、臨床部門等の国内外の関係者との連携による創薬研究の推進
    社内外との共同研究の推進
    医薬品候補化合物の探索プロジェクトならびに開発プロジェクトの推進
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • Job number: JN -072024-146731 Posted: 2024-09-12

    CRA

    CRA
    6 - 8 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
    Responsibilities
    このポジションでは、国全体(米国、APACなど)で進行中のすべての臨床試験および開発プログラムにプロジェクト サポートを提供いただきます。
    また、スタディリードやグローバルスタディチームのメンバーと密接に連携し、臨床段階における製品開発の計画・実行のあらゆる側面において、開発、積極的な管理、
    確実なデリバリー、また前臨床から商業化への製品ライフサイクルを通じて他の機能領域をサポートいただきます。
    <詳細業務内容>
    開発のさまざまな段階で世界中で実施されている1~3件の臨床試験をサポートする場合があります。
    質の高い臨床試験がプロトコールに従って適時に実施され、SOP、ICH/GCP/規制ガイドライン、会社の目標、確立された研究予算に準拠した方法でチームを支援
    主な研究活動と必要性に関する情報を作成、維持、および追跡
    臨床試験を実施するためのさまざまなシステムへのアクセスを作成および維持
    必要に応じ、米国臨床レジストリおよびその他の関連するローカル レジストリを作成および維持
    進行中の臨床文書や活動をサポート
    必要に応じ、適格性審査プロセス、よくある質問、データ審査、調整活動、プロトコル逸脱審査など、その他の主要な臨床活動を支援
    治験実施施設との機密保持契約の法的な執行を調整
    資金管理活動において、臨床業務の主導者を支援し、予算/予測から実際の支出を確認
    サイト固有の規制パケットを取得、確認、追跡し、臨床オペレーションリーダーからの要求に応じて発送を開始
    TMF計画およびファイル試験構造に従い、試験マスターファイルの設定と維持を支援
    TMFのQCレビューを管理し、試験実施全体を通じて部門間でQC活動を調整
    Martin Tsvetkov
    Martin Tsvetkov
    Industrial & Life Science
  • Job number: JN -072024-3357 Posted: 2024-09-12

    Marketing Manager

    Marketing
    10 - 12 million yen Tokyo Pharmaceutical Marketing

    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
    Work with cross-functional teams in sales, digital, marketing to develops field marketingstrategies for raising the awareness of our therapy/ technology in the market.
    Lead the market research to drive the business plan with innovative methods.
    Plan, manage and develop marketing plan
    Martin Tsvetkov
    Martin Tsvetkov
    Industrial & Life Science

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