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Jobs list of Pharmaceutical

325 jobs
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  • Job number: JN -072024-143288 Posted: 2024-10-13

    [Osako or Tokyo] Drug Safety Associate

    New Position with Exciting Salary
    8 - 14 million yen Osaka Pharmaceutical Pharmacovigilance

    Company overview
    Our client is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
    Responsibilities
    THE DRUG SAFETY ASSOCIATE WILL WORK ON SAFETY EVALUATION WORK FOR PHARMACEUTICAL PRODUCTS (INCLUDING INVESTIGATIONAL PRODUCTS), MAINLY INDIVIDUAL CASE EVALUATION, CASE PROCESS WORK AND RELATED WORK
    UNDERSTAND THE OPERATION OF THE SAFETY DATABASE AND THE SYSTEM NECESSARY FOR THE WORK, AND CREATE MANUALS, ETC. AS NECESSARY. 
    RESPONSIBLE FOR-FAMILIARITY WITH SAFETY INDIVIDUAL CASE EVALUATION WORK IN COMPLIANCE WITH GVP AND SOP, AND INSTRUCTING OTHER MEMBERS
    PROPOSING MEASURES AND IMPROVEMENT POINTS FOR PROBLEMS THAT MAY AFFECT BUSINESS PROCESSES, ETC.
    COMPLIANCE DOCUMENT BY REGULATORY AUTHORITIES COOPERATE IN PREPARATION AND RESPONSE TO SURVEYS, ETC.
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -102024-177336 Posted: 2024-10-10

    生産プロセス技術開発(バイオ医薬品)

    大手日系企業 x 多角的な事業展開
    5 - 13 million yen Kanagawa Pharmaceutical Research & Development

    Company overview
    We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
    Responsibilities
    当社の各種細胞に関する知見・ノウハウと、優れた生産プロセス技術を組み合わせた研究開発を推進し、さらなる医療の質の向上、人々の健康維持増進に貢献していきます。これらの実現に向けて、バイオ医薬品の生産性を向上する連続生産プロセスを開発し、その製造導入を行います。
    業務内容:
    バイオ医薬品の生産性を向上する連続生産プロセス(細胞培養・精製)開発~製造導入の推進
    ラボスケールでの培養・精製プロセスの要素技術開発
    ラボ~パイロット~生産スケールへのスケールアップ技術開発
    開発したプロセスの製造導入

    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -092024-176921 Posted: 2024-10-10

    マーケティング市場分析

    プロダクトマネージャーや推進担当などの幅広いキャリアを構成することが可能です
    7 - 10 million yen Tokyo Pharmaceutical Marketing

    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
    業務内容:
    医療用医薬品におけるマーケティング施策の効果検証
    医療用医薬品の売上予測(短期・中長期)
    当該領域の市場分析に基づく担当製品の問題抽出・解決方法の追究
    市場把握/施策の効果トラッキングのためのマーケティングリサーチの設計・検証
    プロダクトマネージャーやオペレーション担当者と共に、医療用医薬品のマーケティング施策の方針策定に携わり担当製品の事業計画達成への貢献に責任を負います。
    Momoka Yamashita
    Momoka Yamashita
    Pharma
  • Job number: JN -082024-173982 Posted: 2024-10-07

    QA Associate Director [GQP]

    GQP Tasks
    18 - 20 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

    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
    This position will be responsible for the General Manufacturing and Sales Manager under the Pharmaceuticals and Medical Devices Act and the Quality Assurance Manager under the GQP Ministerial Ordinance.
    Main responsibilities:
    You will be responsible for quality assurance on our leadership team and will work with the Pharmaceutical Safety Manager to ensure ongoing compliance by making recommendations regarding product safety.
    Based on collated batch records and QC test data conducted in Japan , you will be responsible for continuously monitoring the quality of products imported to Japan and products supplied by contract manufacturers in Japan, and will be responsible for managing the products to ensure their safe shipment.
    You will report safety and quality issues and emergencies to the relevant government agencies in a timely manner.
    Elaine Montes
    Elaine Montes
    Pharma
  • Job number: JN -072024-9547 Posted: 2024-10-07

    クリニカルリサーチ(海外担当)/内視鏡AIの共同臨床研究の交渉や実施など

    海外の医療業界におけるご経験をお持ちの方必見です!
    8 - 12 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is a Japanese AI solutions company specializing in the healthcare sector. With expertise in medical data analysis and advanced AI algorithm development, they are dedicated to addressing key challenges in the healthcare field. Their solutions contribute to optimizing diagnostic support, treatment planning, and overall healthcare efficiency. Much of their investments go into the development of AI solutions for health-related applications, encompassing areas such as patient monitoring, predictive analytics, and overall health management/support.
    Responsibilities
    米国、南米、アジア(シンガポール、韓国、香港、タイ、ベトナム)、欧州(ドイツ、フランス、ポルトガル)の海外医療機関と実施する内視鏡AIの共同臨床研究の交渉や実施及び、論文作成の支援をご担当いただきます。上記対象エリアの共同臨床研究の立案、実施
    提携先医療機関との戦略の立案(学会対応やハンズオンセミナー開催など)
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-145172 Posted: 2024-10-06

    Medical Affairs Review Specialist

    Medical review
    7 - 10 million yen Tokyo Pharmaceutical Medical Affairs

    Company overview
    We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
    Responsibilities
    資材・スライド等の検証
    社内コンプライアンス研修
    部門横断プロジェクトのリード
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -072024-168355 Posted: 2024-10-04

    データマネジメントプロジェクト責任者

    PJTの上流~下流までのデータマネジメント業務に携われる
    4.5 - 7 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Our client is a pioneer and leading CRO contract research organization.
    Responsibilities
    医療機関等から収集したデータ(症例報告書)を予め設定した計画書に基づきデータクリーニングおよびコーディング等のデータ集計および加工する一連の業務を担っていただきます。入社後は、ご経験を踏まえて業務をお任せします。経験の浅い方は、徐々に担当できる業務の幅を広げ、データマネジメントの専門性を深めていただきます。
    業務内容:
    クライアント(依頼者)とスケジュールなどの協議、DM計画書作成
    EDC設計・構築(実際の構築は社内エンジニアチームが担当)
    社内の臨床開発部門・解析部門との連携や業務調整
    プロジェクトのスケジュール管理
    チェックリスト作成
    集計を伴うデータのチェック
    電子化するためのデータベースの準備
    派遣社員マネジメント
    ※データ入力は派遣社員が行います
    Momoka Yamashita
    Momoka Yamashita
    Pharma
  • Job number: JN -072024-142129 Posted: 2024-10-03

    [Tsukuba] Manager of Venture Unit Tumor-directed inhibition

    Global Company!
    11 - 14 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
    Design and synthesize target molecules and analyze assay data for effective drug design as a medicinal chemist
    Participate in program-related meetings and contribute to the progress of the program through useful suggestions and discussions
    Be coordinated with researchers in a chemistry team as well as with multiple expertise such as biology, ADME and toxicology
    Ensure daily experiments to be complied with internal and external laws, regulations, and compliance standards
    -Manage partnership/CRO to promote a research program effectively
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -072024-143283 Posted: 2024-10-03

    [Osaka & Tokyo] Clinical Research Associate (CRA) in Operation

    Rewarding Career, Global Development
    9 - 14 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
    MANAGE / MONITOR THE PROGRESS OF YOUR TRIAL ON-SITE OR OFF-SITE, AND CONDUCT, RECORD, AND REPORT YOUR TRIAL IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL, SOPS, ICH / J-GCP, AND OTHER APPLICABLE LAWS AND REGULATIONS. GUARANTEE THAT YOU ARE
    RESPONSIBLE FOR CONTRACT NEGOTIATIONS AND CONCLUSIONS WITH MEDICAL INSTITUTIONS
    WORK CLOSELY WITH OTHER CLINICAL TEAM MEMBERS TO TIMELY RESOLVE ANY CLINICAL TRIAL ISSUES THAT ARISE
    INEXPERIENCED GIVE APPROPRIATE GUIDANCE TO MEMBERS AND CONTRIBUTE TO THEIR GROWTH
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-38002 Posted: 2024-10-02

    品質管理 (製品品質試験)

    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
    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
    逸脱・トラブルに対する調査及び問題解決策の提案・実施
    変更管理
    新製品導入に伴う試験法技術移管(海外本社・海外製造所と協働して実施)
    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のリード・参画
    その他試験実施に関わる管理業務
    Yui Osone
    Yui Osone
    Pharma
  • 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
    Pharma
  • 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
    Pharma
  • 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
    Pharma
  • Job number: JN -072024-144534 Posted: 2024-10-02

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

    Global Pipeline with Work Life Balance
    4 - 10 million yen Tokyo 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
    Pharma
  • 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
    Pharma
  • 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
    Medical Device
  • 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
    Pharma
  • 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
    Pharma
  • Job number: JN -072024-166795 Posted: 2024-09-30

    【日本橋】マーケティングリサーチ(マネージャー候補)

    マーケティング業務経験者必見です!
    10 - 20 million yen Tokyo Pharmaceutical Marketing

    Company overview
    We are a marketing consulting firm specializing in the pharmaceutical industry in Japan. In particular, we collect and analyze health data and develop diagnostic support systems for medical and research institutions. We utilize cutting-edge artificial intelligence (AI) technology to achieve advanced processing and utilization of medical information. We also promote the effective use of clinical data with the aim of improving the quality and efficiency of medical care. Furthermore, we provide platforms to support patient health management and develop solutions for the digitization of healthcare. In collaboration with medical experts, we are developing innovative services based on the latest medical knowledge and contributing to the development of the healthcare industry.
    Responsibilities
    定量・定性調査の実施・分析等を含め、クライアントである製薬・医療業界企業の商品開発~上市前後のプロモーション業務まで、リサーチ・マーケティング戦略立案から、顧客の中長期的な成長・関係構築に向けたコンサルティングを行います。
    クライアントに対して長期的な提案活動まで可能であるため、成果をフィードバックしながら効果検証を続け、顧客のパートナーとして長期に渡るフォローを行っていきます。
    製薬企業のニーズに基づいた、医師/薬剤師/患者様に対する情報収集、分析、課題抽出、改善策の提案などもお任せします。
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-141139 Posted: 2024-09-29

    [Ascent] CMC RA

    CMC RA
    8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

    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
    Prepare documentation (including for Cartagena Type 1 Applications and CMC Consultations) with team under direction of scientific/ management lead 
    Interact and manage project communications with clients in bilingual environment
    Support interaction with regulatory authorities
    Patrick Chang
    Patrick Chang
    Pharma
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