• Job number: JN -062025-189985 Posted: 2025-06-18

  MDプランナー

  ファッション業界、FMCGでのMDプランナー経験をお持ちの方必見です

  7 - 8.5 million yen Tokyo Supply Chain Management Distribution

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  Company overview

  A global manufacturer of brand-name clothing.

  Responsibilities

  ホールセールにおけるMDプランニングをお任せします。ターゲットとなる顧客を意識した販売計画、予算管理を行い顧客の求める商品を適正な価格、量、タイミングで提供することをミッションとしています。

  

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• Job number: JN -062025-189950 Posted: 2025-06-18

  遺伝子治療の新規技術開発を目指した非ウイルスベクターを用いたデリバリー技術の専門性を有する研究員

  ご自身の専門性を活かし、共に取り組みたいと考える方を心から歓迎いたします

  7 - 12 million yen Kanagawa Pharmaceutical Research & Development

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  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

  ■業務内容：LNPなどの非ウイルスベクターの開発によって、体内の特定の細胞に対して選択的かつ効率的に遺伝子を導入する独自の技術を開発し、遺伝子デリバリー創薬分野における競争力を確立します。さらに、開発した技術を活用した新たな治療法の探索を行い、従来の技術ではアプローチが困難だったターゲットや疾患領域での創薬プロジェクトの提案および推進を担当していただきます。様々な専門性を有する研究員と協働しつつ、ご自身の専門性を発揮していただくことで、革新的な成果を創出します。
  
  ■職種の魅力：当社独自の創薬プラットフォームを活用し、革新的な医薬品の開発に貢献できる人財を募集しています。私たちの使命は、十分な治療法が存在しない患者さんに新たな希望を提供することです。この目標の実現のため、世界トップレベルの科学者たちと協働しながら、ご自身の専門性を最大限に活かし、伸ばす機会を提供いたします。専門知識を基に、まだ誰も踏み入れていない研究領域を探求し、世界中の患者さん及び社会に実質的な価値を提供できる医薬品の開発を目指しています。この貴重な挑戦に、ご自身の専門性を活かし、共に取り組みたいと考える方を心から歓迎いたします。
  
  

  

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• Job number: JN -062025-189971 Posted: 2025-06-18

  海外工場長候補

  製造及び生産設備に携わった経験をお持ちの方必見です

  7 - 13 million yen Tokyo Chemical Production Engineer

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  Company overview

  Our client is an instant food manufacturer.

  Responsibilities

  工場マネージメント業務全般（労務管理、品質&コスト管理、安全衛生、環境保全、SCM業務、現地人材育成など）
  
  現地法人の生産戦略の検討、立案、実行
  トラブル時の対応、是正案の立案、実行管理（重要事案の場合、本社への報告業務を含む）
  
  コスト削減の方策立案、実行管理
  現地法人の取締役業務（状況により）
  

  

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• Job number: JN -062025-189977 Posted: 2025-06-18

  コーポレート戦略・オペレーションマネージャー

  事業企画、経営企画、または事業会社における類似の職務での経験をお持ちの方必見です

  10 - 15 million yen Tokyo Accounting & Finance Business Planning / Corporate Strategy

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  Company overview

  Our client operates IT devices, etc.

  Responsibilities

  法務、財務、ガバナンス、人事などの企業機能を推進し、最適化する
  複数の地域にまたがるグローバルな業務と社内ルールの設計と標準化
  異なる利害関係を持つ部門（ビジネス部門と法務部門など）間の調整と意思決定を主導する
  経営幹部の意思決定に必要な情報を整理し、部門間の連絡役を担う
  部門横断的な取り組みを計画、主導、管理する
  

  

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• Job number: JN -062025-189845 Posted: 2025-06-18

  技術開発 ・製品化設計（印刷ユニット)

  社員一人ひとりの成長を大切に／充実した福利厚生も魅力の一つ

  8 - 10 million yen Aichi Industrial Product Development

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  Company overview

  Our client is a Japanese electronics manufacturer.

  Responsibilities

  In the office business area, we aim to create a sustainable society and digitalize our customers by visualizing and resolving the social and environmental issues faced by our customers through the provision of office-related products centered on MFPs and various IT services. In the Digital Workplace Business, the MFP Process Development Department is consistently involved in the planning, technology development, and commercialization of printing technology for the development of next-generation digital MFPs, and provides new value to customers.
  Main responsibilities:
  Technology development and product design for functional units of MFPs (imaging unit/fuser)
  Development of functional parts of MFPs (rollers/belts, etc.) Business Content
  In order to realize our customers' DX, the Digital Workplace Business aims to build long-term relationships with customers by combining MFPs, related products, and IT services to propose optimal solutions that meet their needs.
  
  デジタルワークプレイス事業は、お客様のDXを実現するため、複合機と関連商材、ITサービスを組み合わせ顧客ニーズに合致する最適なソリューションを提案し、お客様との長期的な関係構築を目指します。オフィス事業領域においては、顧客が直面する社会課題/環境課題に対して、複合機を中心としたオフィス関連商材、各種ITサービスの提供を通して顧客課題を見える化し課題解決する事により、持続可能な社会の形成、顧客のDX化、を目指しています。「MFPプロセス開発部」はデジタルワークプレイス事業の中で、次世代デジタル複合機開発の印刷技術に関して企画から、技術開発、製品化まで⼀貫して関り、顧客への新しい価値提供を実現します。
  業務内容：
  複合機の機能ユニット(作像ユニット/定着器)の技術開発・製品化設計
  複合機の機能部品(ローラ/ベルトなど)の開発
  
  

  

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• Job number: JN -062025-189956 Posted: 2025-06-18

  【東京】グローバルにおけるITガバナンスの構築（管理職ポジション）

  ITガバナンスでの業務経験者必見です!

  9.3 - 15.5 million yen Tokyo Information Technology System Administrator

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  Company overview

  We provide products, services, and mobility technology related to automobiles. We offer technology and solutions to automobile manufacturers and related industries, supporting performance improvement, safety, and environmental considerations. Moreover, we focus on developing advanced technology and innovative products, positioning ourselves as one of the leading companies in the automotive industry. As an independent global supplier, we serve automotive and motorcycle manufacturers worldwide, consistently engaging in cutting-edge technology development. We can handle both domestic and international clients, expanding our opportunities to contribute globally.

  Responsibilities

  世界5地域（米、欧、中、アジア、日）のIT規定の棚卸、評価
  全社IT規定の整備、包括管理（ITポリシーハウスの構築）
  ガバナンス強化に向けた業務プロセスの見直し、改善、実行
  各種監査プロセスのドキュメント化、関連ドキュメントの整備、ガイドラインの発行
  リスクマネジメント、及び全社リスク管理体制との連携
  ITの目的意識を定義、明確化しその達成手法を検討する。またそれらをITビジョンやミッションに取り込み、戦略的な実行計画を策定する
  ITガバナンスの枠組みを設計し実行する。目的、ガバナンスプリンシパル、ポリシーやガバナンスメンバーの役割と責任及びプロセスを策定し、枠組みと合わせて、会社のビジネスゴールや戦略施策を支える形を整える。
  COBITやTOGAFなどのべスプラフレームワーク手法を用いて推進し、必要に応じて更新する
  IT組織の倫理規定を、モラルや価値観をもとにHRと共創する。ルールや基準を設け、ITスタッフのあるべき姿勢や行動規範を定義する。
  ガバナンス関連の教育やトレーニングの構築を支援しIT組織の文化を醸成する。IT組織内外との接し方、姿勢を定義する
  ガバナンス部門の責任であるコンプライアンスを向上維持させ、IT組織が常に法規、規則や規約に準じた業務が行るよう支援し、ガバナンスフレームワークと合わせて倫理/文化フレームワークの醸成を行う。
  効果的なリスクマネジメントプロセスを確立する。全社のリスクマネジメントを支援し、ITに関わる事業継続性や危機管理を行う。ITの全てのグローバルファンクションやリージョン、サイトにいたるまでの活動をモニターし指導する
  

  

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• Job number: JN -062025-189843 Posted: 2025-06-17

  自動化装置技術者

  日々進歩するロボティクスやAI画像解析技術を活用し、常に時代の先を行く

  6.5 - 8.5 million yen Aichi Industrial Production Engineer

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  Company overview

  Our client is a Japanese electronics manufacturer.

  Responsibilities

  当社では、生産工程における自動化の取り組みを進めており、現在は少量多品種製品の生産性向上、AI検査導入による品質向上、物流自動化にもミッションを拡大し自動化に取り組んでいます。主力事業の二事業の原価低減に貢献する重要な役割を担っています。
  業務内容：
  情報機器生産拠点の中期自動化設備導入計画の立案・推進
  国内外の情報機器事業の生産拠点への自動化推進
  部品サプライヤ等取引先への自動化推進
  生産工程に導入する自動組立・自動検査装置の工程設計、自動化設備構想設計、設備設計から現場立ち上げ
  組立/調整/検査の自動化要素技術開発（ロボット・機器の制御技術、ハンド技術、AI画像認識技術等）
  開発部門と連携した自動化し易い製品設計への変更提案
  中期自動化設備導入計画および技術開発計画の立案
  

  

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• Job number: JN -042025-187604 Posted: 2025-06-17

  FP&A担当

  行きたくなるオフィス／スキルアップのための研修あり

  8 - 15 million yen Tokyo Accounting & Finance Financial Analysis / FP&A

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  Company overview

  Our client is a real estate developer and an investment company that also invests in related business areas.

  Responsibilities

  業務内容：
  年次予算策定業務関連部署、戦略チームと連携し、予算策定に向けたプロセスをリードし、各部署から収集した様々な情報をもとに年次予算および中長期予測を策定し、経営陣やグローバルチームへ説明を行う。
  
  予実管理業務策定した予算を基に四半期等での予実管理を行い、その過程で生じた経営課題の解決をサポート・推進する。
  
  年次経営計画策定のサポート各部門がボトムアップで作成する経営計画を確認しつつ、主にファイナンシャルや予算との整合性の観点からのインプット・サポートを行う。
  
  各種KPI策定・管理業務戦略チーム、グローバルチームと連携し、全社のKPIを検討/策定の上、進捗管理を行う。
  
  

  

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• Job number: JN -072024-15412 Posted: 2025-06-17

  Controller

  グローバルに事業を展開する医療機器メーカーです

  9.5 - 11.5 million yen Tokyo Accounting & Finance Controller

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  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

  事業計画作成と予実管理業務。組織各部門の事業活動をモニタリング、組織の売上と収益の拡大に結び付けるバックオフィス業務
  月次決算、年次決算業務、P/L、C/F、A/R、与信管理に関する管理と分析
  日本法人として、納税や配当金の管理、税務調査対応
  カンパニーの中長期的な成長と収益拡大を推進させる事業計画やKPIを策定しマネジメント
  米国本社との月次ミーティング参加（Teams等）
  関連部署と連携し、戦略や施策実現を適時適格に行われる共闘体制に参画
  関連部署と一緒に事業オペレーションの実行
  収益改善やコストダウンに取り組み、既存オペレーション方法の見直し・革新（デジタルトランスフォーメーション）を実現する
  

  

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• Job number: JN -062025-189363 Posted: 2025-06-16

  医療機器開発 - プログラム医療機器の臨床開発

  【東京】評価の高いプログラム医療機器の臨床開発

  6 - 10 million yen Tokyo Medical Device Clinical Trials / Clinical Development

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  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

  【担当職務】AIを活用した医療機器の臨床評価設計や、医療機関・規制当局との連携を通じた承認取得業務などの多岐にわたる業務をリードしていただきます。＜具体的には＞①プログラム医療機器（SaMD）の臨床開発└性能評価試験の設計デザイン└試験計画書や承認申請書類等のメディカルライティング└試験の進捗管理及び施設対応や医師折衝└試験結果の統計解析・考察└CROコントロール及び管理└社内関連部門、外部審査機関との折衝②各提携先病院・大学との臨床開発や共同研究の推進└研究実施機関との契約及び倫理審査手続き└研究の進捗管理及び施設対応や医師折衝
  【仕事の魅力】・最新の医療AI（SaMD）の開発に関わることができる・医療AIの社会実装を推進することで医療の質向上に貢献できる・多くの関係者を巻き込みながらプロジェクトを推進できる
  

  

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• Job number: JN -062025-189661 Posted: 2025-06-16

  内部監査

  海外に駐在した経験がある方必見です。

  8 - 13 million yen Tokyo Accounting & Finance Audit / Risk

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  Company overview

  Out client is a non-life insurance company.

  Responsibilities

  コンプライアンス態勢整備へ向けた企画・立案（海外コンプラ関連の規程整備、コンプライアンス・プログラムの策定）
  コンプライアンス事項に関する支援・指導
  
  

  

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• Job number: JN -072024-32242 Posted: 2025-06-16

  Clinical Marketing TMTT

  新規事業部のClinical Marketing

  6 - 9 million yen Tokyo Medical Device Marketing

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  Company overview

  We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.

  Responsibilities

  Lead business expansion, especially market share increase by penetrating compelling clinical contents with evolving related stakeholders
  Main responsibilities:
  Develop clinical contents strategy of congress seminar and BU initiated events with evolving stakeholders (Product marketing, Congress mgmt, ProfEd and Medical affairs) and review it periodically
  Create compelling clinical contents for external dissemination
  Proactively identify, assess, and summarize relevant clinical literature not only TMTT area but also related therapeutic area
  Provide promotional training to sales team to implement and enhance clinical sales approach to deliver 'Values' to customers
  Create meaningful contents (procedual techniques, case mgmt, competitor info etc) for internal use by attending congresses and communicating global team
  Establish customer relation through creating clinical contents
  Others
  

  

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• Job number: JN -072024-25913 Posted: 2025-06-16

  Regulatory Affairs Specialist

  Global pioneer in healthcare industry

  7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

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  Company overview

  We specialize in the development and marketing of medical devices. We provide advanced medical devices used primarily in the fields of cardiovascular, urology, and gastroenterology to assist in the treatment and diagnosis of patients. With an emphasis on innovative technology and research and development, we are continuously introducing products to the market that meet the needs of the medical field. Our product lineup includes catheters, stents, and endoscopic devices that boast high quality and safety. Through collaboration with medical experts, we also aim to promote effective therapies and improve medical technology. With a mission to improve the quality of life of patients, we leverage our global network to provide superior solutions to medical institutions around the world.

  Responsibilities

  Main responsibilities:
  Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
  Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
  Provide management team with regular updates on product registration and new regulations from government body.
  Provides input on regulatory- related issues associated with compliance and achieving the business plans.
  Prioritize and plan on product registration for his/her respective product lines.
  Preparing, coordinating and submitting regulatory applications to the local health authority.
  Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
  Provide the management team with regular updates on product registration.
  Ensure product registrations are reviewed and renewed as required.
  Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
  Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
  Supports tender operations by timely supply of accurate regulatory documents.
  Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
  Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
  Serves as regulatory consultant to marketing team and government regulatory agencies.
  Complete the mandatory Quality training subject to the defined timeline.
  And ensure compliance with internal Quality system and policy.
  

  

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• Job number: JN -072024-34143 Posted: 2025-06-16

  CRD x Ambassador

  営業リードの獲得にご興味ある方

  7 - 10 million yen Osaka Medical Device Sales

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  Company overview

  We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.

  Responsibilities

  Represents the business to targeted customers in order to increase awareness of the business and its brand, generate sales opportunities and build customer preference. Embodies what the company stands for and creates awareness, attention and sales lead opportunities.
  Main responsibilities:
  Represent the company and its products to the media and customers in a positive manner.
  Has well-developed knowledge of the company’s sales and marketing goals and objectives and executes initiatives to achieve them.
  Plan and implement awareness creating programs to reach out to potential customers.
  Share customer feedback to the company in anticipation of improving products and services and participate in developing marketing ideas.
  Develop and maintain strong communication with buying offices and customers.
  Conduct product training and handle inventory preparation initiatives.
  Monitor brand movement, pricing and distribution penetration.
  Build and sustain business relationships with key accounts within assigned areas.
  

  

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• Job number: JN -112024-179334 Posted: 2025-06-16

  Product Manager PI_

  Commit to both personal and professional commitments

  10 - 14 million yen Tokyo Medical Device Marketing

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  Company overview

  Our Client is a global medtech company that provides medical devices, lab equipment, and diagnostic products in their focus areas such as medication management, infection prevention, diagnostics, and healthcare delivery solutions.

  Responsibilities

  Main responsibilities:
  Drive top line by working closely with sales team while maintaining the business profitability and Gross Profit (GP) targets.
  Develop and implement marketing strategies and tactics to maximize commercial outcome by working closely with internal functional teams: e.g. sales managers, trainers.
  Work with/Establish KOLs via developing strong relationship in order to execute business unit strategy.
  Work with sales trainers and build training programs for local sales teams and distributor reps to penetrate critical marketing messages, such as product positioning and competition analysis.
  Build marketing plan for responsible products and obtain management approval as needed. See ahead to future possibilities and translate them into breakthrough strategies.
  Obtain & update market insight by visiting current customers as well as prospects.
  Prepare a new product launch plan and obtain management approval. Take an ownership for domestic product launch initiative.
  Expand market through customer education and enlightenment of appropriate use.
  Plan and execute events such as academic conferences, exhibitions, seminars and events for building and maintaining key customer relationship.
  

  

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• Job number: JN -072024-30044 Posted: 2025-06-16

  Product Marketing (TAVI) | プロダクトマーケティング（TAVI）

  製薬業界マーケティングからのご応募も可能です！

  7 - 9 million yen Tokyo Medical Device Marketing

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  Company overview

  Our primary business is the import and sale of medical devices, offering devices for testing and treatment of cardiovascular diseases. We have also entered the field of neurosurgery, which is a new business area for us. Our mission is to help healthcare professionals treating patients with cardiac, neurological, and chronic pain around the world gain access to superior treatment tools. We focuse on the development of medical technologies and services that contribute to the reduction of risk and the successful treatment of all patients.

  Responsibilities

  The TAVI Product Manager is responsible for setting strategic direction in Japan for the portfolio and for tactical implementation of activities aligned to a patient-centric, customer-centric and goal-achieving culture, leading to optimal clinical adoption, outcomes, and customer satisfaction within the space.The TAVI Product Manager is responsible for the following related to their portfolio:
  Main responsibilities:
  Develop Japan-specific marketing strategies and tactics for new product launches including market analysis, clinical strategy, reimbursement strategy, product positioning and messaging.
  Contribute to the achievement of objectives via development and close execution of annual marketing plans.
  Design and prepare the workflow, procedure, logistics and documentation required for product launch and business operation driving the cross-functional teams.
  Plan and execute TAVI marketing tactics, especially for messaging for brand positioning and differentiation, peer to peer event to demonstrate product benefit, and activities to deepen customer engagement in TAVI market.
  Set appropriate KPIs (leading KPIs, activity KPIs, clinical KPIs and performance KPIs) for marketing tactics, analyze data and track to take timely corrective actions as necessary
  Leverage customer relationships, technical expertise and product knowledge to plan and coordinate new launches, and provide the sales team with appropriate messaging, campaigns and tools highlighting objective, relevant differentiation. 
  Develop promotional tools and optimize others provided by Global Marketing; launch with appropriate localization, training, and tracking.
  Create open, productive lines of communication between the sales and clinical team and all other areas that affect the product: Regional and Global Marketing, RA, QA, etc.
  Provide clinical and sales staff with clinical knowledge and promotional guidance, ensuring products are targeted appropriately to satisfy customer needs and expectations.
  Stay up-to-date on key publications, trials, indications, society guidelines, and market dynamics and reflect to the communication / marketing strategy
  Interface with Public Relations firms, market research companies; design agencies and other vendors and customers to effectively grow business in a profitable manner while maintaining a customer focus throughout all activities. 
  Develop and maintain professional relationships with key customer accounts as well as market influencers.
  The TAVI Product Manager is responsible for achievement of the goals and objectives associated with their products including revenue, margin, and expense budget. Business Process goals will be measured against commitments in the annual marketing plan. Strict compliance with the company's Quality System and all Ethics/Compliance guidelines is required
  

  

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• Job number: JN -072024-34389 Posted: 2025-06-16

  Marketing Communication

  顧客Facingな仕事がしたい方歓迎です

  8 - 11 million yen Tokyo Medical Device Marketing

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  Company overview

  We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.

  Responsibilities

  Manage annual congress strategy and seek opportunities to expand company presence.
  Main responsibilities:
  Manage all national and regional medical congresses from development to implementation; provide support for global congresses as needed
  Negotiate higher volume and complex contracts
  Develop strategies for the effective management and execution of medical congresses, marketing events and projects intended to maximize company exposure and produce sales leads
  Develop relationships with associations to ensure maximum exposure and greatest benefit for Edwards sponsorship and participation
  Manage relationships with multiple vendors and lead vendor teams for congress execution and event management
  Manage new booth development; audit booth asset inventory; remain current on new trends in exhibit design
  Plan and execute educational symposia and customer events within medical congresses; contract negotiations, logistics, F&B, AV
  Active budget forecasting, management and reconciliation; and fiscal responsibility
  Lead cross functional teams to successful results
  
  

  

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• Job number: JN -052025-188968 Posted: 2025-06-16

  Senior Safety Control Specialist

  Advance surgery, empower teams, and change lives

  7.6416 - 11 million yen Tokyo Medical Device Regulatory Affairs (RA)

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  Company overview

  Our client is the global technology leader in minimally invasive surgery.

  Responsibilities

  Main responsibilities:
  Preparation and implementation of GVP in compliance with Japanese PAL.
  Collection and first reviewer of local and overseas post-marketing safety information.
  Review / approve the evaluation of local and overseas post-marketing safety information.
  Manage an outsourced contractor daily work.
  Complaint handling management for filings and prepare the customer letter.
  Communication with head office on complaint cases for preparation of customer letter.
  Support quality management activity and work with QA team to maintain the appropriate quality 
  management system. 
  Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality 
  management in a timely manner.
  Continuous improvement and management of the safety/quality assurance process in accordance with Product Development Process. 
  Work directly with regulatory agencies on safety/quality issues and submissions. 
  Documentation of Package Insert and PMDA web maintenance of Package Insert
  

  

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• Job number: JN -072024-141139 Posted: 2025-06-16

  [Ascent] CMC RA

  CMC RA

  8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

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  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
  

  

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• Job number: JN -072024-138039 Posted: 2025-06-16

  CRA/Senior CRA

  Both RA and Clinical work

  8 - 11 million yen Tokyo Pharmaceutical Clinical Development

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  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

  Clinical Development Operations:
  Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
  Primary point of contact of trial sites with regards to the conduct of the study/ project
  Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
  Ensure that the sites are adequately trained on the protocol and other study specific requirements
  Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
  Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
  Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
  Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
  Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
  Track site budget and payments
  May be involved in preparation of status reports for clients
  Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
  Act as mentor/coach to more junior staff as necessary
  Travel as necessary according to project needs
  Perform other duties as assigned by line manager.
  
  Regulatory:
  
  Ensure study start up processes are done according to applicable SOPs and regulatory requirements.
  Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
  Ensure that product labels are compliant with applicable regulatory requirements
  Collect and submit necessary documents for study drug importation, return and/ or destruction
  Ensure that all documents necessary for site activation are collected
  

  

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