Jobs list

Safety Specialist

理系卒未経験の方歓迎

6 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control

Company overview: Our client is the global technology leader in minimally invasive surgery.
Responsibilities: 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.

Shotaro Tsubaki
Industrial & Life Science

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

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.

Product Manager PI_

Commit to both personal and professional commitments

10 - 14 million yen Tokyo Medical Device Marketing

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.

Lead Regulatory Affairs Specialist (Project Leader), Japan

Leading ｍedical device manufacture

8 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: Our client stands as a prominent player in the field of medtech, providing a wide range of offerings including medical equipment, medical imaging processing devices, diagnostic tools, and life science-related equipment. It delivers products and solutions aimed at advancing diagnostics, treatments, and healthcare, operating across the comprehensive spectrum of medical technology and diagnostics.
Responsibilities: 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.

Takahisa Hitotsumatsu
Industrial & Life Science

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

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

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

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

Senior specialist/manager, Regulatory Affairs

勤務地は東京or大阪（リモートワーク有）

7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

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: 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

Product Manager (Marketing)

Improve lives through innovation & collaborative teamwork

6 - 9 million yen Tokyo Medical Device Marketing

Company overview: Our client is a foreign medical device manufacturer.
Responsibilities: 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.

Senior Safety Control Specialist

Advance surgery, empower teams, and change lives

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

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

Quality Assurance Specialist (Product Quality)

Advance robotic-assisted surgery w/ cutting-edge innovation

6.4345 - 9 million yen Tokyo Medical Device Quality Assurance / Quality Control

Company overview: Our client is the global technology leader in minimally invasive surgery.
Responsibilities: 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.

【Abiomed】Product Manager, Marketing

医療機器業界でのプロマネご経験者必見です！

7 - 13 million yen Tokyo Medical Device Marketing

Company overview: We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
Responsibilities: 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.

[Janssen] Contract & Compliance Services, Site Engagement Analyst

Open to CRO CRA Candidates

6 - 9 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: 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

QA Manager

10 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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: 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.

Martin Tsvetkov
Industrial & Life Science

Medical Affairs PM

Medical PM

8 - 14 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: 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.

[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

Regulatory Affairs Specialist

Tokyo or Osaka OK

8 - 10 million yen Osaka Pharmaceutical Regulatory Affairs

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: 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.)

CRA/Senior CRA

Both RA and Clinical work

8 - 11 million yen Tokyo Pharmaceutical Clinical Development

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

【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

10.5 - 13 million yen Tokyo Sales & Marketing Business Development / Sales

Company overview: We are a comprehensive heavy industrial manufacturer operating in a wide variety of industrial fields. We primarily provide products and services in the aerospace, defense, energy, plant, and social infrastructure sectors. Leveraging our engineering capabilities and technological innovation, we design and manufacture advanced machinery and systems, contributing to the sustainable development of society. In addition, to address environmental issues, we are actively promoting the use of eco-technologies and renewable energy to solve the problems of society as a whole.
Responsibilities: 【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。

【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

7.8 - 13 million yen Tokyo Industrial Plant Manager

Company overview: We are a comprehensive heavy industrial manufacturer operating in a wide variety of industrial fields. We primarily provide products and services in the aerospace, defense, energy, plant, and social infrastructure sectors. Leveraging our engineering capabilities and technological innovation, we design and manufacture advanced machinery and systems, contributing to the sustainable development of society. In addition, to address environmental issues, we are actively promoting the use of eco-technologies and renewable energy to solve the problems of society as a whole.
Responsibilities: 【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。

【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

6.2 - 10.4 million yen Tokyo Industrial Sales

Company overview: We provide industrial robots, electrical equipment, and automation technology. We mainly provide solutions aimed at automating factories and plants, saving energy, and improving efficiency, thereby helping to increase productivity in a variety of industrial sectors. We focus on providing customized solutions to meet our customers\' needs using the latest technologies and innovations.
Responsibilities: 【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。

Jobs list of 6 - 14 million yen

Safety Specialist

CRD x Ambassador

Product Manager PI_

Lead Regulatory Affairs Specialist (Project Leader), Japan

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

Marketing Communication

Senior specialist/manager, Regulatory Affairs

Product Manager (Marketing)

Senior Safety Control Specialist

Quality Assurance Specialist (Product Quality)

【Abiomed】Product Manager, Marketing

[Janssen] Contract & Compliance Services, Site Engagement Analyst

QA Manager

Medical Affairs PM

[Ascent] CMC RA

Regulatory Affairs Specialist

CRA/Senior CRA

【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）

【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

【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

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