Jobs list of Pharmaceutical
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NEWJob number: JN -072024-138031 Posted: 2025-10-13
Cell medicine researcher
Cell medicine researcher5 - 9 million yen Tokyo Pharmaceutical Pre-Clinical Trials
- Company overview
- Our client is a biotech venture with the mission of developing cancer peptide vaccines
- Responsibilities
- Development of cell medicine
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -072024-143283 Posted: 2025-10-09
[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation
Rewarding Career, Global Development9 - 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
Industrial & Life Science -
NEWJob number: JN -112024-180118 Posted: 2025-10-09
海外現地法人責任者（ASEAN諸国の責任者）
マーケティング～M＆Aなど幅広い経営の仕事を紹介できます10 - 20 million yen Overseas Pharmaceutical Marketing
- Company overview
- Our client is a pharmaceutical company.
- Responsibilities
- 業務内容：
ASEAN諸国の子会社の責任者候補として入社いただくことを想定。
現法の責任者として事業経営全般をお任せします。
リーダーシップを発揮して事業計画の策定から推進を担い事業拡大に意欲的に取り組んでいただくことを期待
責任者 ：海外現地法人の事業経営全般
Yui Osone
Industrial & Life Science -
NEWJob number: JN -072024-137931 Posted: 2025-10-09
Non-Clinical Manager
1st Non-Clinical Member in Japan10 - 12 million yen Tokyo Pharmaceutical Pre-Clinical Trials
- Company overview
- We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
- Responsibilities
- Contribute to the development the strategy from nonclinical perspective.
Provide / lead the nonclinical-related parts of regulatory documents.
Interpret the outcomes from studies for clinical and plan/manage appropriate studies.
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -072024-36526 Posted: 2025-10-09
Medical Science Liaison (MSL) - 糖尿病領域
MSL position at global maker with strong pipeline7 - 11 million yen Tokyo Pharmaceutical Medical Affairs
- 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
- 職務内容/Job Responsibilities
担当疾患領域（糖尿病／循環器疾患）の専門家として病態や治療薬に関する深い知識を背景に、領域専門医等からの医学・科学的な疑問点やニーズに対応することにより、患者さんの病状改善やＱＯＬ向上に貢献する。また領域専門医等との議論を通じて得た意見やニーズを社内関係部署に還元し、製品価値の最大化に貢献する。
主な職責/Primary responsibilities
領域専門医等のリクエストに応じて、最新医学・科学情報を提供・議論する
領域専門医等の意見、疑問、ニーズならびに共同研究などの機会を探索・収集し、社内関連部署と連携して解決策を探る。
サイエンティフックエキスパート（SE）/ソートリーダー(TL)との関係構築並びに良好な関係維持を行う。
Yui Osone
Industrial & Life Science -
NEWJob number: JN -072024-5073 Posted: 2025-10-09
Clinical Trial Manager
CTM8 - 10 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
- 臨床試験マネージャーは、治験の開始からデータベース管理まで、臨床業務に従事していただきます。
臨床試験における様々な側面を管理するマネージャーポジションです。
他部門との連携が多数発生します（アメリカ拠点との英語コミュニケーション有）。
定められた目標、タイムライン、予算、および適用される規制要件を順守し、治験の開始から割り当てられたデータベース管理までの臨床試験の運用面を監督します
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -072024-6846 Posted: 2025-10-09
Inexperienced CRA
Inexperienced4.5 - 6.5 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
- 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、治験実施計画書、SOP に則って治験が進んでいるかを確認
直接閲覧（SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
IRB（治験審査委員会）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 等
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -072024-143827 Posted: 2025-10-09
品質保証 QA
Global Company6 - 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
- 医療機器、再生医療製品等を含む新たなモダリティへの業務展開
新たな技術の導入、技術の進化
サプライチェーンの多様化
グローバル製品（開発品・市販品）の増加
製造委託先、試験委託先ならびに原材料供給業者の増加
そのため、GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務に精通した要員の補充が必要となった。
IND/IMPD、NDA/BLA作成及び推進、国内申請資料作成及び推進、その他CMC薬事にかかわる業務
Patrick Chang
Industrial & Life Science -
NEWJob number: JN -072024-143287 Posted: 2025-10-09
[Osaka or Tokyo] Medical Writer of Drug Development
Great Company Culture8 - 14 million yen Tokyo Pharmaceutical Research & 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
- PREPARATION OF CLINICAL
TRIAL PROTOCOL- PREPARATION OF CLINICAL TRIAL SUMMARY REPORT
PREPARATION OF DRUG APPROVAL APPLICATION MATERIALS (CTD: COMMON TECHNICAL DOCUMENT) (CLINICAL PART ONLY)
PREPARATION OF INVESTIGATIONAL DRUG SUMMARY
REVIEW OF ABOVE-MENTIONED DOCUMENTS
CORRESPONDENCE BY AUTHORITIES (CLINICAL PART DOCUMENT CREATION, REVIEW, CONSULTING, ETC.)
GENERAL CONSULTING FOR DOCUMENT CREATION THAT MEETS REGULATORY REQUIREMENTS
CONTRIBUTING AS A LEADING ROLE IN THE ABOVE
APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS AND CONTRIBUTION TO MEMBER GROWTH
Patrick Chang
Industrial & Life Science -
NEWJob number: JN -072024-143554 Posted: 2025-10-09
Clinical Project Manager / Clinical Leader
Global Trail and high salary8.5 - 17 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- Manage Clinical Trials
Patrick Chang
Industrial & Life Science -
NEWJob number: JN -052025-187960 Posted: 2025-10-08
PV staff(安全性情報担当)
医薬品製造販売業もしくはCROにおける安全性業務経験者（3年以上）をお持ちの方必見です5.5 - 7 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- We have been contributing to the improvement of patient welfare and access to healthcare by offering innovative biologics to the world.
- Responsibilities
- GVP、GCPに基づく安全性評価業務、安全対策業務安全管理業務全般：安全性情報の評価、当局報告
安全確保措置の検討、立案
RMP策定および管理
安全性情報管理に係る各種ドキュメント作成
社内他部署との連携業務
国内および海外提携会社との連携業務
業務委託先（CRO）の業務管理
教育訓練、自己点検
SOPの運用、管理
規制当局、提携会社等による査察・調査等への対応
その他、安全性に関する業務
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -102025-194836 Posted: 2025-10-08
医療機器営業
プロダクトマーケティングに関する実務経験をお持ちの方必見です5 - 10 million yen Tokyo Pharmaceutical Marketing
- Company overview
- A global medical technology company, we develop and manufacture innovative non-invasive patient monitoring technologies, including medical devices and a broad range of sensors.
- Responsibilities
- 他部門と協業し持続的な成長に向けたマーケティング戦略を策定し実行をお任せいたします。具体的には:
アキュートケア、オルタネートケア、ホームケア製品のマーケティング戦略立案
各種販促資料等の制作、出版
関連部署を巻き込んでの新製品の導入計画の策定及び実施
販促目標達成のための社内関連部署への通達、連絡および調整
潜在的パートナー企業の調査、分析
Go Ozawa
Industrial & Life Science -
NEWJob number: JN -102025-194715 Posted: 2025-10-08
【東京】臨床開発リード ◇グローバルバイオファーマ／神経学・免疫学に特化◇
臨床開発戦略の立案と実行をリード10 - 17 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a company engaged in the manufacturing, sales, import, and export of pharmaceuticals and quasi-drugs. Guided by our philosophy of "enhancing people\'s health and contributing to a richer society," we focus on the introduction and development of innovative new drugs, particularly anti-allergy medications. As medical technology advances with developments such as genomic drug discovery and personalized medicine, we are committed to going beyond the fundamental role of the pharmaceutical industry to support a comfortable life for people, especially in an aging society. Our business includes the import, export, manufacturing, and sales of pharmaceuticals and quasi-drugs, chemicals (such as methylamine and plasticizers), and films (such as label films and sterilization paper). We continually strive to provide truly useful pharmaceuticals to many people, always challenging and progressing forward.
- Responsibilities
- 情熱的で、成長志向があり、戦略的思考力のあるクリニカル・ディベロップメント・リードを募集しています。東京に拠点を置く臨床開発チームの一員として、担当製品の日本における臨床開発戦略の立案と実行をリードしていただきます。社内外のステークホルダーと連携しながら、規制当局対応、申請書類作成、外部専門家とのネットワーク構築などを通じて、製品の成功に貢献する役割です。
■業務内容：日本における臨床開発計画の立案と実行
規制当局との対応および申請書類の作成支援
外部専門家とのネットワーク構築と関係維持
臨床試験の設計、実施、評価、報告の監督
社内外ステークホルダーへの戦略説明と調整
薬事申請、承認、上市に向けた臨床面での貢献
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -102025-194797 Posted: 2025-10-08
医薬事業開発担当
ヘルスケア業界において他社との交渉をまとめ上げた経験や協業をリードしたご経験をお持ちの方必見です6.45 - 10.61 million yen Tokyo Pharmaceutical Regulatory Affairs
- 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
- グローバル展開する同社の医薬品提携業務として、アライアンスマネジメント業務または医薬品ライセンス業務での中心的な役割を果たしていただきます。具体的な業務:
１．アライアンスマネジメント業務（1）提携先との交渉提携後に必要な各種契約の交渉、締結
契約外の事象の取り扱いに関する交渉
（2）提携先との会合の主催各提携品目について年間1～2回開催される運営委員会を主催
各提携品目について週1回～月1回の頻度で開催される定期的な打ち合わせを主催（開発、製造関連のものを含む）
上記の会合のための社内外調整と当日のファシリテーション
（3）社内各部署と提携先との協業サポート自社および提携先の各部署間で開催する打ち合わせへの参加
各部署が主体で締結する契約書のレビューに参加
各部署が契約に基づいて業務を遂行できるように助言、問い合わせへの対応
（4）提携品目に関わる社内対応各種契約の締結に際する決裁対応
中期経営計画、ライフサイクルマネジメントの議論への参加
２．医薬品ライセンス業務（1）導入対象品目の選定社内関係部署と導入戦略、導入領域の立案・選定
導入対象品目へのアプローチ
マッチングカンファレンスにおける案件探索
（2）導入対象品目の評価社内関係部署を用いて案件の科学的評価、事業性評価、当社適合性評価、競合分析等
評価結果を基に導入判断
（3）導入契約の契約交渉、締結Capability Presentation等の社内取りまとめ、先方提示等のマネジメント
ビジネススキームの検討、提案
契約交渉、及びそれに伴う社内関係部署との調整
Yui Osone
Industrial & Life Science -
Job number: JN -072024-38866 Posted: 2025-10-06
Quality Assurance Senior Manager
Full Remote QA Senior Manager position12 - 15 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- The company is a foreign-affiliated pharmaceutical company.
- Responsibilities
- Provide strong support team management for GQP Head on day-to-day basis
Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS
Perform other duties as assigned such as described below, but are not limited to:
Provide support for regulatory agency inspection readiness and requests
Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
Support business develop
Yui Osone
Industrial & Life Science -
Job number: JN -072024-145164 Posted: 2025-10-06
Medical Information Specialist/Mangger
医療業界における顧客対応経験が活かせます。6 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- （1）担当する領域の製品、開発品に関する学術的な問い合わせ（電話およびMR経由の依頼）の二次対応（製品情報センターで回答できなかった場合の対応）…文献調査、文献選定、文献内容の要約もしくは関連部署からの情報収集により回答を準備し、電話または文書にて実施（2）問い合わせ対応データから顧客のニーズを判断し、提供用のQ＆A、製品情報センターの口頭回答用のQ&Aを作成、改訂（3）担当する領域の製品に関する顧客からの要望・提案、問い合わせにより生ずるリスクに対し、リスク最小化およびビジネス最大化のための対策を講じる（4）担当製品の関連情報の提供・収集を行い、医療現場における適正使用を確保（5）販売提携などのコ・プロモーション製品においては、提携会社と円滑に情報共有が実施できる体制を構築し、両社における情報提供の整合性を確保（6）グローバルMI担当領域製品チームの一員として下記業務を実施英語での科学的な回答文書（GSRD）の作成、レビューおよびGSRDの日本向けのローカライズを実施
海外からの英語での問い合わせに対応(文書回答)する。
（7）GPT（グローバル製品チーム）に参加し、日本のマーケット状況等を共有し、グローバルとしての最適なアクション立案に貢献※専門管理職は上記に加え、マネジメント業務について相応の役割を担っていただきます。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-37223 Posted: 2025-10-03
製薬メーカーでの内勤サポート <オフィスメディカル>
豊富なキャリアパス／研修教育環境充実6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- <業務内容＞
オフィスメディカルは、メディカルアフェアーズ機能の内勤職として、医療現場における『アンメットメディカルニーズを把握』し、把握したニーズを充足することにより医療上の価値を最適化するための『メディカルプラン』に基づいて『エビデンスを創出』すると共に、創出したエビデンスを含む医学・科学的情報を『適切に発信、提供』を行う役割を担っていただきます。
業務内容は役割により多岐に渡りますが、代表的な業務内容を下記に記載いたします。
オフィスメディカルには「メディカルアドバイザー」「サイエンスコミュニケーションズ」「メディカルインフォメーション」と呼ばれる職種が該当します。
メディカルプランの作成
アドバイザリーボードの立案/実行
メディカルイベントの企画/実施
資材作成やスライドレビュー業務
パブリケーション戦略、メディカルエデュケーション企画実施
医療従事者や社内 MR、患者様からの取扱製品に関する問い合わせ対応
メディカルインフォメーション（2 次対応）
最新医学情報の収集と社内関連部署への提供
グローバル関連部署との折衝やコミュニケーション
関連業務のサポート全般（書類等の作成、確認、保管、発送業務等）
■研修体制：
同社の豊富な実績やデータ、ネットワークをもとにヘルスケアの基礎から、営業・マーケティング、臨床、データ・テクノロジー、マネジメント・リーダーシップ、経営など、これからの医療・ヘルスケアの担い手に求められる多様なプログラムが体系化されています。MSL専門プログラムも用意されており、基礎から応用、実践まで対応可能です。
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-143843 Posted: 2025-10-03
Medical Writer
Medical Writer8 - 12 million yen Tokyo Pharmaceutical Regulatory 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
- Preparation of investigational drug summary (IB)
Preparation of a general report (CSR)
Creation of Approval Application Material (CTD) Clinical Part
Preparation of draft package insert (clinical part) for development products
Preparation of face-to-face advice (pre-application consultation) materials
Creating answers to inquiries regarding clinical parts after application for approval
Publication of clinical trial results on the clinical trial information registration site
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -102025-194654 Posted: 2025-10-03
PMSスペシャリスト
ファーマコビジランスに関する専門知識と規制理解をお持ちの方必見です7 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are a company engaged in the manufacturing, sales, import, and export of pharmaceuticals and quasi-drugs. Guided by our philosophy of "enhancing people\'s health and contributing to a richer society," we focus on the introduction and development of innovative new drugs, particularly anti-allergy medications. As medical technology advances with developments such as genomic drug discovery and personalized medicine, we are committed to going beyond the fundamental role of the pharmaceutical industry to support a comfortable life for people, especially in an aging society. Our business includes the import, export, manufacturing, and sales of pharmaceuticals and quasi-drugs, chemicals (such as methylamine and plasticizers), and films (such as label films and sterilization paper). We continually strive to provide truly useful pharmaceuticals to many people, always challenging and progressing forward.
- Responsibilities
- 情熱的で、柔軟性があり、責任感の強いファーマコビジランススペシャリストを募集しています。東京に拠点を置くチームの一員として、承認後の医薬品の安全性監視と適正使用を支えるためのシステム運用、調査実施、規制対応を担っていただきます。社内外のステークホルダーと連携しながら、患者の安全と企業のコンプライアンスを両立させる重要な役割です。国内PVシステムの構築・運用と規制遵守
GPSP/GVPに基づく市販後調査の計画・実施・分析
PMDA対応のための文書管理体制の整備
再審査申請やJ-PSURの提出業務
監査・査察対応とCAPAの実施
社内外ステークホルダーとの連携によるPVコンプライアンスの確保
科学的情報の収集・共有とメディカル戦略への貢献
医薬品の価値向上に向けた問い合わせ分析と情報発信
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -092025-194319 Posted: 2025-09-26
マスターファイル登録・審査対応
ビジネスメールにて基本的な対応が可能なレベルの英語力を有する方必見です8 - 11 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a company that offers a diverse range of products and services, including chemicals, plastics, electronic components, machinery and equipment, and food products. With a long history and based on strong relationships with our customers and partners, we are expanding our business both domestically and internationally. We also focus on technological development and environmental initiatives, actively contributing to the realization of a sustainable society. In a wide range of industrial fields, we are continuously growing to meet the diverse needs of our customers by leveraging our expertise and flexible response capabilities.
- Responsibilities
- 入社後の主な担当領域入社後は、既存マスターファイルの維持管理に加え、長期収載品に関する原薬のマスターファイル登録および審査対応をご担当いただきます。
また、新規の後発医薬品に関する原薬についても、マスターファイルの登録と審査対応業務をお任せいたします。
加えて、当社における医薬品製造業（表示・保管）に関するGMP業務（製造管理および品質管理業務）の支援業務をご担当いただく可能性がございます。
将来的な業務展開中長期的には、ご本人の希望や適性を踏まえながら、原薬関連のレギュラトリ業務に加え、化粧品や食品に関するレギュラトリ業務、さらには海外地域におけるレギュラトリ業務にも取り組んでいただく可能性があります。
Martin Tsvetkov
Industrial & Life Science