• 求人番号：JN -072024-33523 掲載日：2025-06-16

  Safety Specialist

  理系卒未経験の方歓迎

  600 - 1000 万円 東京 医療機器 品質保証 / 品質管理

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  会社概要

  手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。

  業務内容

  Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market. Take timely and appropriate quality management actions and executing communications with government and internal / external customers. This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:
  Main responsibilities:
  Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
  Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
  Evaluate customer complaints from the viewpoint of product quality, report to company and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
  Completing quality issues by working with regulatory agencies, customers and related functions.
  Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
  Involve in implementation of a field action like a recall.
  Collaborate with QRC team to maintain Quality Management System.
  Work related to product realization (control DMRs and materials for released products etc.)
  Operate product release (IQC, labeling instructions, and market release assessment etc.)
  Manage non conforming products (rework, concession, and hold etc.)
  Work related to data analysis and CAPA.
  

  

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• 求人番号：JN -072024-34143 掲載日：2025-06-16

  CRD x Ambassador

  営業リードの獲得にご興味ある方

  700 - 1000 万円 大阪 医療機器 営業

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  会社概要

  同社は様々な製品を提供する世界有数の医薬品、健康管理事業を行っている米国企業の日本法人です。
  診断薬・機器、医薬品、病院用製品、栄養剤など多彩な製品群を持ち、診断から治療まで広範囲にカバーする高品質・高機能の製品とサービスを提供し、高い評価を得ています。もちろん部門間での異動や情報共有もされており、総合ヘルスケアメーカーとして圧倒的な地位を築いています。

  業務内容

  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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• 求人番号：JN -112024-179334 掲載日：2025-06-16

  Product Manager PI_

  Commit to both personal and professional commitments

  1000 - 1400 万円 東京 医療機器 マーケティング

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  会社概要

  同社は、医療技術（メドテック）分野のグローバル企業です。医療機器、研究設備、診断製品、薬剤管理や感染予防などの医療ソリューションを強みとして医療従事者から親しまれています。

  業務内容

  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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• 求人番号：JN -042025-187215 掲載日：2025-06-16

  Lead Regulatory Affairs Specialist (Project Leader), Japan

  Leading ｍedical device manufacture

  800 - 1000 万円 東京 医療機器 薬事

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  会社概要

  同社は医療機器、医療画像処理機器、診断機器、生命科学関連機器などを提供する大手メドテック企業です。診断、治療、ヘルスケアの向上を支援するための製品やソリューションを提供しており、総合的な医療技術および診断の領域で活動しています。

  業務内容

  Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
  RA project leader is responsible for all RA tasks of own modality without detailed supervision by the direct manager. As a project leader, lead RA members to submit in time as necessary providing guidance from an experienced professional standpoint. Report to direct manager or to core-team co-workers about submission projects status when it’s requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.
  Main responsibilities:
  Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
  Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
  Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
  Assesses changes in existing products to and determines the need for new /revise licenses or registrations.
  Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
  Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
  Contributes to writing and editing technical documents.
  Assesses adverse events through approved license dossier to support Safety Management Team.
  Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required.
  Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.)
  Ensures compliance with pre- and post-market product approval requirements. (Lead communication with authorities as necessary and take appropriate action without detailed supervision of direct manager.)
  Supports regulatory inspections as required. (Support direct manager to have internal and external audit.)
  Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
  
  

  

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• 求人番号：JN -072024-30044 掲載日：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！

  700 - 900 万円 東京 医療機器 マーケティング

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  会社概要

  同社は、医療機器の輸入と販売を主な事業とし、循環器系疾患の検査および治療用デバイスを提供しています。また、神経外科領域にも進出し、新たな事業分野として取り組んでいます。同社の使命は、世界中の心臓病や神経系、慢性疼痛の患者の治療に携わる医療従事者が優れた治療手段を手に入れることを支援することです。リスクの軽減と全ての患者の治療の成功に貢献し、医療技術とサービスの開発に注力しています。

  業務内容

  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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• 求人番号：JN -072024-34389 掲載日：2025-06-16

  Marketing Communication

  顧客Facingな仕事がしたい方歓迎です

  800 - 1100 万円 東京 医療機器 マーケティング

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  会社概要

  同社は日本の医療機器メーカーで、グローバル・メディカルカンパニーとして患者の生活の質向上を目指しています。重度の循環器疾患治療・測定用医療機器の開発・製造・販売・サービスを手掛け、特に弁膜症治療に使用される人工心臓弁や弁形成術製品、また血行動態モニタリングなどのクリティカルケア製品では世界のトップシェアを誇っています。また、環境保護、社会貢献、企業ガバナンスの責任を重視し、持続可能な取り組みを推進しています。医療従事者向けのサポート情報や教育ツールの提供にも力を入れており、世界中で活動しています。

  業務内容

  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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• 求人番号：JN -082024-173752 掲載日：2025-06-16

  Senior specialist/manager, Regulatory Affairs

  勤務地は東京or大阪（リモートワーク有）

  700 - 900 万円 東京 医療機器 薬事

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  会社概要

  同社は、医療技術（メドテック）分野のグローバル企業です。医療機器、研究設備、診断製品、薬剤管理や感染予防などの医療ソリューションを強みとして医療従事者から親しまれています。

  業務内容

  Job Description Summary:
  A global medtech company is looking for a highly motivated individual to join our team as Regulatory Affairs Specialist/Manager in the Pharmaceuticals Division. The successful candidate will be responsible for obtaining regulatory approval of new products and maintaining existing licenses in line with local regulations, while ensuring compliance with all relevant laws and regulations. This role will involve collaborating closely with cross-functional teams to ensure timely and effective product launches, as well as ongoing support for marketed products. The position requires excellent organizational skills, attention to detail, and strong communication abilities.
  Job Responsibilities:
  Lead and coordinate regulatory activities related to drug registration, including preparation of required documents and submission to authorities.
  Collaborate with internal stakeholders such as R&D, Manufacturing, Quality Assurance, Marketing and Sales to gather information necessary for regulatory submissions.
  Ensure compliance with all relevant regulations and guidelines, including GCP standards.
  Stay updated on changes in regulatory requirements and guidance documents, and implement appropriate measures to address any impacts on current or future registrations.
  Maintain accurate records of all regulatory documentation, including filings, correspondence, and inspection reports.
  Support preparation and review of promotional materials to ensure compliance with regulatory requirements.
  Coordinate interactions with regulators during site visits or meetings, providing clear and concise explanations of technical aspects related to product registration.
  Work closely with external consultants and experts to facilitate smooth progress of registration process.
  Provide regular updates to management regarding status of registration activities.
  
  ━━━━━━━━━━━━━━━#poweredjob3

  

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• 求人番号：JN -052025-189088 掲載日：2025-06-16

  Product Manager (Marketing)

  Improve lives through innovation & collaborative teamwork

  600 - 900 万円 東京 医療機器 マーケティング

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  会社概要

  同社は、外資系医療機器メーカーです。

  業務内容

  Main responsibilities:
  Product management and promotion work for medical devices and related solutions in the field of sleep apnea syndrome and respiratory related diseases.
  Planning and executing product lifecycle management and marketing strategies for the product group in charge.
  Education, clinical and product support for products and related treatments.
  Domestic operation of in-house developed software.
  Understanding and analyzing market trends.
  Planning and implementing various academic conferences and events.
  

  

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• 求人番号：JN -052025-188968 掲載日：2025-06-16

  Senior Safety Control Specialist

  Advance surgery, empower teams, and change lives

  764.16 - 1100 万円 東京 医療機器 薬事

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  会社概要

  手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。

  業務内容

  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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• 求人番号：JN -052025-188955 掲載日：2025-06-16

  Quality Assurance Specialist (Product Quality)

  Advance robotic-assisted surgery w/ cutting-edge innovation

  643.45 - 900 万円 東京 医療機器 品質保証 / 品質管理

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  会社概要

  手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。

  業務内容

  This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality.
  Main responsibilities:
  Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
  Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
  Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
  Completing quality issues by working with regulatory agencies, customers and related functions.
  Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
  Involve in implementation of a field action like a recall.
  Collaborate with QRC team to maintain Quality Management System.
  Work related to product realization (control DMRs and materials for released products etc.)
  Operate product release (IQC, labeling instructions, and market release assessment etc.)
  Manage non-conforming products (rework, concession, and hold etc.)
  Work related to data analysis and CAPA.
  

  

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• 求人番号：JN -072024-169637 掲載日：2025-06-16

  【Abiomed】Product Manager, Marketing

  医療機器業界でのプロマネご経験者必見です！

  700 - 1300 万円 東京 医療機器 マーケティング

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  会社概要

  医療・健康関連製品を提供する世界的な医療機器・製薬会社です。医薬品、医療機器、消費財などの製品を取り扱い、健康な生活を支援するさまざまな製品を提供しています。特に、医療技術や研究開発への投資を通じて、先進的な医療ソリューションを提供し、医療の質と効率を向上させています。また、教育や啓発活動を通じて、社会の健康意識を高め、より良い未来の実現に貢献しています。

  業務内容

  Main responsibilities:
  Launch and roll-out new products safely and successfully, and eventually, make the product the standard of care by working cross-functionally with the rest of Mktg, RA, QA, supply chain, field service, education, and the clinical sales team in Japan – as well as with the overseas headquarters including product & software engineering teams and downstream/upstream marketing teams.
  Manage projects of product approval and reimbursement by working closely with RA, Medical Affairs, and the Reimbursement team.
  Implement training plans with the Education team - including preparing user manuals, physician/staff/company employee training materials.
  Develop and coordinate product supply and demand plans with SCM to ensure that product supply is delivered without delay.
  Execute a marketing strategy with Marketing Director by building a deep understanding of the target market and the therapies where the product can be utilized. This includes products and software, and also by building strong relationship with Japanese KOLs.
  Conduct marketing activities with Marketing Director through multiple promotional channels, including company-hosted events, academic societies, marketing materials, digital marketing, etc.
  Collect feedback through internal stakeholders and physician/staff interviews, capturing both bright spots as well as aspects needed to improve a go-to-market strategy, value propositions, and key claims /messaging.
  Provide professional clinical- and business-oriented support to clinical sales team as an Impella product/service expert.
  
  

  

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• 求人番号：JN -072024-144139 掲載日：2025-06-16

  [Janssen] Contract & Compliance Services, Site Engagement Analyst

  Open to CRO CRA Candidates

  600 - 900 万円 東京 製薬 臨床開発

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  会社概要

  同社は、世界的な製薬企業の一部であり、医療・健康分野に特化した製品とサービスを提供しています。主に医薬品の研究開発、製造、販売を行い、疾病の治療や予防に貢献しています。革新的な医療技術と科学的アプローチに基づき、高度な研究と開発を進め、新たな治療法や医薬品を市場に提供しています。また、医療従事者や患者への教育活動や支援プログラムも展開し、医療の質の向上に寄与しています。グローバルに展開するネットワークを活かし、多様な地域と市場でのニーズに応え、持続可能な医療イノベーションを推進しています。

  業務内容

  Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
  Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
  Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
  Manage the contract amendment lifecycle.
  Assume responsibility for all aspects of legal document and metrics tracking.
  Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
  Comply with requests from QA and auditors.
  Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
  Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
  Exemplary customer focus with vision to drive solutions
  

  

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• 求人番号：JN -072024-137933 掲載日：2025-06-16

  QA Manager

  QA Manager

  1000 - 1200 万円 東京 製薬 品質保証 / 品質管理

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  会社概要

  は、日本国内において医療技術の研究開発と提供を行っています。特に、革新的な治療法の開発に注力し、がん治療に関する先端的な技術を提供しています。光免疫療法という新しい治療アプローチを用いて、がん細胞を標的とした効果的な治療を目指しています。この技術は、光と薬剤を組み合わせることで、選択的にがん細胞を破壊することが可能です。研究開発においては国内外の専門機関や大学との連携を強化し、臨床試験や実用化に向けた取り組みを進めています。医療分野における革新と患者の生活品質向上を目指し、日々努力しています。

  業務内容

  Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
  When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
  Ensure full compliance with applicable regulations in Japan.
  Oversee all activities or responsibilities that are delegated to external parties.
  

  

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• 求人番号：JN -072024-143159 掲載日：2025-06-16

  Medical Affairs PM

  Medical PM

  800 - 1400 万円 東京 製薬 メディカルアフェアーズ

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  会社概要

  同社はアメリカを拠点とする親会社を持つ大手ライフサイエンス企業です。主に医薬品やワクチンの研究開発、輸入、製造、販売を事業として展開しています。人々の健康を守り、豊かな人生を築く手助けをすることで、同社の使命・目標に向かって日々奮闘し、日本の満たされていない医療ニーズにいち早く応えてゆきます。さらに、さまざまなプログラムやパートナーシップを通じ医薬品を必要とする人々への製品寄付や供給を行い、医薬品へのアクセスを推進する活動に積極的に取り組んでいます。

  業務内容

  1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
  In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
  In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
  Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
  For US headquarters-led research, work with headquarters personnel to promote the project.
  
  2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
  In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
  Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
  Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
  When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
  After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.
  

  

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• 求人番号：JN -072024-141139 掲載日：2025-06-16

  [Ascent] CMC RA

  CMC RA

  800 - 1200 万円 東京 製薬 薬事

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  会社概要

  Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC

  業務内容

  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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• 求人番号：JN -052025-188683 掲載日：2025-06-16

  Regulatory Affairs Specialist

  Tokyo or Osaka OK

  800 - 1000 万円 大阪 製薬 薬事

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  会社概要

  同社は医薬品の開発過程を支援する各種の受託事業をおこなう日系企業です。医薬品の臨床試験データの収集・分析、薬事申請の支援、品質管理などの業務を担当しています。専門家チームがお客様のニーズに合わせたソリューションを提供し、安全性と有効性の確保に努めています。同社は、厳格な規制に準拠し、高品質なサービスを提供することに注力しています。お客様の医薬品開発の成功をサポートするために、経験と知識を活かしたプロフェッショナルなサポートを提供しています。

  業務内容

  Main responsibilities:
  Work related to the preparation, maintenance, and management of clinical trial applications and attached documents
  Various consultations with regulatory authorities (PMDA, MHLW, etc.)
  Work related to approval applications (support for client applications)
  Work related to the collection, maintenance, and management of pharmaceutical information
  Other (participation in various meetings, training, etc.)
  

  

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• 求人番号：JN -072024-138039 掲載日：2025-06-16

  CRA/Senior CRA

  Both RA and Clinical work

  800 - 1100 万円 東京 製薬 臨床開発

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  会社概要

  Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC

  業務内容

  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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• 求人番号：JN -062025-189751 掲載日：2025-06-16

  【豊洲】ビジネスアナリスト（DX推進におけるプロジェクトマネジャー）

  日本を代表する総合重工業メーカー／海外売上比率約5割超のグローバル企業

  1050 - 1300 万円 東京 営業＆マーケティング 事業開発 / 営業

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  会社概要

  同社は、多岐にわたる産業分野で活動する総合重工業メーカーです。主に、航空宇宙、防衛、エネルギー、プラント、社会基盤の各分野で製品とサービスを提供しています。エンジニアリング能力と技術革新を活かし、高度な機械装置やシステムの設計・製造を行い、社会の持続可能な発展に貢献しています。また、環境問題への対応として、エコ技術や再生可能エネルギーの活用を積極的に推進し、社会全体の課題解決に取り組んでいます。

  業務内容

  【日本を代表する総合重工業メーカー／海外売上比率約5割超のグローバル企業】
  ■業務内容：本社機能を主に担当するチーム、あるいは事業部門を担当するチームいずれかのビジネスアナリストとして、以下のようなDX推進業務に従事いただきます。最新のテクノロジーを活用し、攻めのITとして、業務改革をリードしていきます。
  ■業務詳細：業務プロセス分析、課題抽出、改善・変革の提案
  経営管理・事業運営・業績管理に必要な指標やKPIの設計およびモニタリングシステムの構築
  各業務部署のキーメンバーおよびデータサイエンティスト等とチームを組み、複数のプロジェクトマネジャーとして業務要件定義や、ソリューション選定から業務展開・定着化までの一連のフェーズをマネジメントし、業務改革を実現する（例えば、Aras－Infor Syteline等による設計製造プロセスのデジタルスレッドやSalesforce／Snowflake／Tableau等のモダンデータスタックを活用した実践的な業務に携わっていただきます）
  ナレッジをベースに、SBU／国内外関係会社と連携したグループ横断の仕組み整備（全体最適）
  経営幹部や各事業領域長へのレポート
  まずはご経験を一番活かせるプロジェクトからスタートし、プロジェクトマネジャーとして、本社機能やバリューチェーンの各工程における業務の要件定義から設計・実装までをリードいただきます。日本国内のみならず、海外関係会社へ展開する案件にも携わっていただき、グローバルを舞台に活躍の幅を広げていくことも可能です。
  ■アピールポイント：同社グループでは業務効率・生産性向上と変革が求められています。非効率な業務や急激な経営環境変化に迅速に対応するため、デジタル・ITを活用し変革をリードし、プロジェクトを完遂する人材を増員中です。注力事業や経営基盤を支える変革プロジェクトの中核メンバーとして参画可能で、経営幹部との直接対話や横断組織との連携を通じて企画・実行に取り組めます。社会貢献度の高い製品に携わることで、社会貢献を実感できるポジションです。
  

  

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• 求人番号：JN -062025-189750 掲載日：2025-06-16

  【昭島】民間航空機用エンジン部品・モジュールの生産戦略立案～マネジメント

  日本を代表する総合重工業メーカー／海外売上比率約5割超のグローバル企業

  780 - 1300 万円 東京 製造（電子 / 電気 / 機械） プラントマネージャー

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  会社概要

  同社は、多岐にわたる産業分野で活動する総合重工業メーカーです。主に、航空宇宙、防衛、エネルギー、プラント、社会基盤の各分野で製品とサービスを提供しています。エンジニアリング能力と技術革新を活かし、高度な機械装置やシステムの設計・製造を行い、社会の持続可能な発展に貢献しています。また、環境問題への対応として、エコ技術や再生可能エネルギーの活用を積極的に推進し、社会全体の課題解決に取り組んでいます。

  業務内容

  【日本を代表する総合重工業メーカー／海外売上比率約5割超のグローバル企業】
  ■概要：同社は日本のジェットエンジン生産の60～70％を担うリーディングカンパニーとして、大型から小型まで各種民間航空機用エンジンの国際共同開発事業にも参画し、エンジンモジュールや部品を開発、供給しています。エンジンは分業構造（プログラム）としてOEM（エンジン取りまとめ会社）とサプライヤーのもとで開発～生産が行われており、同社が担当する各エンジンの部品・モジュール生産における戦略立案から出荷までのマネジメント、およびQCD改善に伴う生産プロセスの最適化等に携わっていただきます。
  
  ■業務内容：民間航空機用エンジン（GEnx／CF34／GEPassport20／PW1100G－JM 等）のいずれかの機種における、航空エンジン部品・モジュールの統括リーダーとして、設計変更、生産戦略立案および生産管理計画の策定と、その進捗管理を、社内部門（設計部門／生産部門／購買部門等）や、社外（海外エンジンメーカー／サプライヤー）の幅広いステークホルダーとコミュニケーションを取りながら行っていただきます。お客様（海外OEM）のフロントとして、週に1～2回の英語を使った定例や、社内担当者との調整業務が発生します。さらに、目の前のカイゼンだけでなく、同社の事業競争力向上を目指した、生産効率の改善やゼロディフェクト活動の推進、およびQCDバランスの最適化等に向けたロードマップの企画などに幅広く携わっていただき、航空エンジンのリーディングカンパニーとして日本や世界の空の交通を支えていただきたいと考えています。
  
  ■アピールポイント：設計、生産から出荷後までのあらゆるプロセスをリードするポジションとして、自身の担当製品を搭載したエンジンが、日本や世界の空を飛ぶ実感を得ることができます。実際にそのエンジンが搭載された航空機に乗る機会もあり、自身の業務が人々の生活に貢献しているやりがいを感じることができます。また、海外OEMへの出張で実際に組み上げられたエンジンを見たり、試験を見たりと、様々な経験を積むことができます。エンジンのQCDに幅広く関わることで、グローバルな折衝や問題解決を通したプロジェクトマネジメントスキルを身に着けることができます。
  

  

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• 求人番号：JN -062025-189749 掲載日：2025-06-16

  【東京】既存顧客向け　アフターセールス業務◇世界4大産業用ロボットメーカー

  ローカルディビジョンマネージャーなどへのキャリアステップが目指せます

  620 - 1040 万円 東京 製造（電子 / 電気 / 機械） 営業

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  会社概要

  同社は、産業用ロボットや電気機器、オートメーション技術を提供しています。主に工場やプラントの自動化、省エネルギー化、効率向上を目指すソリューションを提供し、さまざまな産業分野での生産性向上をサポートしています。最新の技術とイノベーションを駆使し、顧客のニーズに応じたカスタマイズされたソリューションを提供することに注力しています。

  業務内容

  【世界4大ロボットメーカー／顧客の電化、脱炭素化を支援する最先進技術を開発・導入、低炭素で資源効率の高い未来へ貢献】
  ■業務内容：EL事業本部で扱うすべての製品（EVチャージャー除く）をお使いいただいている既存顧客へのアフターセールスをお任せします。
  ■業務詳細：（1）スペアパーツ受注後すぐ、製品の納品前に顧客を訪問し、今後始まるコミッショニングで不具合があった場合に備えてあらかじめパーツの購入を提案
  （2）メンテナンス試運転後、顧客のメンテナンス担当者を訪問し、数か月から数年後のメンテナンスを提案
  ※現状メンバー2名のうち1名は社内のコミッショニング案件を担当しているため、もう1名のメンバーと連携しながら顧客のフォロー、関係維持構築を行っていただくことを期待しています※案件受注後はプロジェクトマネジメントチームにハンドオーバーします
  ■ミッション：ELサービス事業部の営業を担当部門 の販売を担当し、指定された市場で戦略に基づいて活動します
  長期的な顧客関係を構築し、顧客のニーズや問題に対応します
  販売機会を特定／開発し、競合他社の設置基盤に対してもリバンピング市場を目指す活動を推進します
  
  ■主な責任：アカウント戦略の策定
  販売目標の設定・提案
  アカウントプラン
  顧客との関係の確立・戦略立案
  顧客知識の獲得・維持・共有
  数量と利益（販売・契約推進）
  市場活動（戦略の策定・実行）
  営業
  マーケティング
  管理業務
  
  ■ポジションの魅力：ローカルディビジョンマネージャー（サービス部門部長）などへのキャリアステップが目指せます。
  

  

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