医療機器 × 臨床研究・臨床開発 の求人情報一覧
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NEW求人番号：Job-00240703 掲載日：2023-03-24
Clinical Lead
World\'s number 1 Ophthalmology company1000 - 1400 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 眼科医療のリーディングカンパニーです。
- 業務内容
- 開発戦略の作成・立案
国内臨床試験計画の作成及び実施（プロトコール作成、総括報告書作成、CROマネジメント）
海外臨床試験データの評価（効能効果、適応疾患などの観点から）
承認申請資料の作成、承認申請後の対応（PMDA照会事項への回答作成等）
PMDA適合性調査の準備
PMDA対面助言相談の実施
臨床研究の実施 （プロトコール作成からデータベース固定まで）
Linh Do
Medical Device -
NEW求人番号：Job-00231018 掲載日：2023-03-20
Lab Supervisor
world\'s largest animal health company750 - 900 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 食品、水質試験、獣医学の領域におけるトップレベルの開発、製造、製品提供を行っている企業です。
- 業務内容
- Manage and supervise each staff in the performance of their duties, together with motivating for Targets and Goals, supporting for their achievement and appropriate feedbacks.
Maintain and monitor Quality Control Programs and Quality Assurance Program; review results, take appropriate corrective action.
Dedicate to manage and improve Laboratory testing process flow, from specimen requisition to, all kinds of testing and reporting.
Lead, direct and manage staff, in order to improve efficiency of routine works within the team.
As the Lab Supervisor in charge of General testing, communicating with other related depts., aim to improve overall Lab service and quality.
Recognize Lab staff’s skills and provide opportunity and support to brush up and acquire.
Direct and supervise each staff in the performance of their duties
Support Lab Manager to build strong team with customer satisfaction focused.
Take care of escalation of customer related complaints or claims.
Manage metrics of Lab operation, analyzing data, establishing counter measures, execution and reporting.
Report to Lab manager and explain to related depts, about Lab operations including any activities, achievements, incidents and accidents etc.
Communicate with related depts or Global team for future growth of Japan Lab and improvement of customer satisfaction.
Vendor management and budget control.
Recruitment and attendance management for Lab staffs
Linh Do
Medical Device -
NEW求人番号：Job-00225454 掲載日：2023-03-20
【東京】薬事（医療機器/承認申請マネージャー）
冠動脈治療用バルーン国内シェアトップクラス800 - 1000 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社は、アジアに本社を置く医療機器メーカーです。
- 業務内容
- 製品開発本部・薬事品質保証部において、高度管理医療機器（カテーテル）の承認申請業務に従事していただきます:
医薬品医療機器等法に基づく承認申請書の作成
部下の業務を含めた申請業務全体のマネジメント
承認申請に係る関係官庁との折衝
薬機法及び関連法規に係る情報収集（国内外の学会参加／業界団体会合への参加等）
海外の開発／製造部門との折衝（e-mail等）
非臨床試験の実施に係る調整業務（PMDA及び海外部門との協議に基づく）
Chiaki Sakane
Medical Device -
NEW求人番号：Job-00222219 掲載日：2023-03-18
Data Scientist, Regulatory Affairs Strategy
【東京/大手外資系医療機器メーカー】薬事申請データ管理、戦略立案800 - 1200 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社はグローバルヘルスケアリーディングカンパニーです。
- 業務内容
- Key Objectives:
This position is key strategic capabilities that Regulatory Affairs (RA) will build to strengthen the data-driven decision-making enabled by advanced data analytics. You will be responsible for crafting, developing, and fielding data solutions in Japan Regulatory Affairs to maximize our value with effect and efficiency. You will report to Senior Manager, Japan RA Strategy team.
Responsibilities:
Mine and analyze data from function and/or company databases to drive optimization and improvement of regulatory activities, function strategies and function/company processes.
Build projects and develop data solutions that support the execution of Japan RA activities to maximize our value.
Assess the effectiveness and accuracy of new data sources and data gathering techniques.
Develop custom data models and algorithms to apply to data sets.
Develop predictive model related to the resource allocation and performance.
Lead and coordinate with different functional/regional teams to implement models and monitor outcomes.
Lead and work effectively with different stakeholders in a cross functional team environment.
Key Competencies:
Teamwork/Communication – Able to effectively partner across functions and region. Able to influence across the organization to drive the higher performance of Regulatory Affairs.
Goal setting – In case it’s under the unstable situation, proactively able to set the goal and take an action.
Possible thinking – able to think how to make it happen by collaborating with others etc, not think about the reason why we cannot make it happen.
Shotaro Tsubaki
Medical Device -
求人番号：Job-00240061 掲載日：2023-03-16
Boston Clinical PM
World leading medical device maker800 - 1300 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 世界最大級の医療機器メーカーです。
- 業務内容
- Responsible for conducting clinical trials for approval of medical devices and applying for approval of clinical data. In addition, we are responsible for applying for approval using overseas data, conducting post-marketing use-results surveys, and applying for use evaluation.Plan, formulate, prepare, and implement projects (clinical trials, use-results surveys, post-marketing clinical trials, etc.) and collect safety and efficacy data on medical devices
Approval application based on collected clinical data, use results evaluation application, and related administrative responsesManage project budgets, timelines, milestones and deliver on schedule
Manufacture of equipment used in clinical trials, drafting import plans, arranging overseas and building domestic equipment management processesSelection, contract, and management of various domestic and foreign vendors
Preparation of protocols, clinical trial device brochures, and other documents related to clinical trials
Management and approval of contracts with medical institutions and cost negotiations
Organize and facilitate project meetings and collaborate with Clinical Research Associates, Data Management, Biostat, Safety, Medical Experts, Field Clinical Specialists, Headquarters Clinical Development Team
Building relationships and cooperation with the responsible doctor, sub-medical doctor, coordinator, etc. of the medical institution
Approval application using existing overseas data as much as possible
Linh Do
Medical Device -
求人番号：Job-00232712 掲載日：2023-01-19
IT Business Analyst (Sales IT)
【東京】大手医療機器メーカー800 - 1200 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社は、医療機器のリーディングカンパニーとして世界的に有名な企業です。
- 業務内容
- Become critical bridge role between North Asia Sales& Marketing business and IT. Main mission is to consult, deliver and support IT solutions, mainly Salesforce.com with balance of business value and IT strategies as a team member. - Lead discussions with business users to elicit complete and accurate requirements - Analyze requirements and propose solutions based on constraints and capabilities ofSalesforce.com - Plan new projects and get agreement from stakeholders - Execute project as a lead business analyst aligned with global IT governance - Responsible for support and operation of our team applications - Contribute to improve application utilization - Take a balance of delivering outcomes to North Asia business and aligning with APAC business and global IT direction
Go Ozawa
Medical Device -
求人番号：Job-00230552 掲載日：2023-01-19
ｺﾏｰｼｬﾙｴｸｾﾚﾝｽ ｽﾄﾗﾃｼﾞｯｸﾌﾟﾗﾝﾆﾝｸﾞ SFE リード
【東京】大手外資系SFEリードポジション800 - 1000 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社はグローバルヘルスケアリーディングカンパニーです。
- 業務内容
- コマーシャル部門の一員として、CXグループマネージャー、営業本部、マーケティング本部、並びに他部門と連携し、顧客満足向上と業績目標達成に貢献する。1. データに基づく営業戦略・施策の立案と実行のサポートならびに導入
2. Sales Force Effectiveness (SFE)関連のプラットフォーム(Eyeforce, Tableau、等)のビジネスアドミン
3. その他、SFE関連のプロジェクトリード
DUTIES & RESPONSIBILITIES
営業戦略、戦術の立案と導入。Strategic Planning Mgrと共にデータに基づく価値あるインサイトを提供し、ビジネスゴールの達成を実現する。
定期的に営業活動に関する実績を把握/分析し、ゴールやKPIに対する進捗を確認しステークホルダーにレポートする。ギャップがある場合は、問題/課題の提起、解決方法の提案を行う
SFE関連のプラットフォーム（CRM及びデータ分析ツール等）のビジネスアドミンとして、ビジネスやユーザー（営業部、など）ニーズを把握し、またグローバルやASPACリージョン、ITとも連携することで、価値の高いビジネスインフラ構築とタイムリーな情報配信を実現する
SFE（Sales Force Effectiveness)関連のプロジェクトをAPリージョンやITと連携してリードする。
Go Ozawa
Medical Device -
求人番号：Job-00231830 掲載日：2023-01-19
コマーシャルエクセレンス、グループマネージャー
【東京】コマーシャルエクセレンスグループマネージャー1000 - 1300 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社はグローバルヘルスケアリーディングカンパニーです。
- 業務内容
- 1. Sales Operation Leading sales data management to support sales activities for achieving BP, driving business for mid term
Responsible for Distributor management in terms of quality management, compliance (due diligence), and rebate contracts
Planning and execution of Sales Programs / Financial Programs for distributors & Hospital/Clinics with preparation and management of contract format
Prepare Sales Incentive program based on BP to drive business
Plan and execute sales campaign to accelerate sales according to market situation and sales trends
Manage capital assets consignment (compliance / BP)
2. SFE Analyze sales performance per accounts and provide periodical reports & insights to support Sales & Marketing strategy planning and execution with customer & market data collected.
Lead and enhance SFE & CRM data management & operation efficiency to achieve BP and drive business.
Deploy, optimize and maintain sales processes and tools to drive business strategies and initiatives.
3. Commercial Operation Take a critical role in designing and monitoring commercial approach and translating strategic objectives into operational plans
Support local SCM by collaborating with Sales & Marketing, Planning and Deliver team and the other functions to maintain product supply and inventory at proper level based on BP
Set and manage commercial operation rules to optimize Shipment, Consignment, and Inventory management in order to prevent back orders and excessive inventory
Provide the constructive suggestions to improve efficiency in commercial operation, prioritize items to be improved, take leads for execution of projects, and track progress and results to make sure of improvement in customer satisfaction and efficiency of commercial operation.
Lead to introduce the global project relating commercial operation system (ex. EyeScan) in Japan
4. Sales Training Manage the development and implementation of the sales training, product training as well as sales management training program.
Help accelerate onboarding training to develop new sales force effectively.
Provides expertise and guidance to sales management on the establishment of training priorities for both long term and short term objectives.
5. Strategic Planning ＆ Execution Work with Sales and Marketing and the other key functions in the organization to generate commercial strategy and business plan
Lead strategic planning initiatives, ensure successful execution by tracking progress and developing action plans for driving performance
Review and drive business performance by market & business insights development, opportunity & risk assessment
Develop KPIs and Generate business performance reports to monitor and improve business performance
6. People Development & Management in Commercial Excellence OrganizationBuild and provide the vision of organization
Maintain strong team engagement to deliver high quality, high performance and best results of the organization.
Develop and maintain healthy pipeline of successor of CommEx Organization
Provide development opportunity to individuals to help them grow to achieve long-term organizational goal.
Go Ozawa
Medical Device -
求人番号：Job-00222218 掲載日：2023-01-19
Data Science & Analytics Manager
【東京/大手外資系医療機器メーカー】ビジネス課題の抽出・解決900 - 1300 万円 東京 医療機器 臨床研究・臨床開発
- 会社概要
- 同社はグローバルヘルスケアリーディングカンパニーです。
- 業務内容
- Key Objectives:
Strategic Insights and Advanced Analytics (SI&AA) are key strategic capabilities that Medical Company will build to strengthen our competitiveness through data-driven decision-making enabled by market and competitive insights and advanced data analytics. The Manager for Data Science & Analytics will be responsible for crafting, developing, and fielding data solutions in Medical Company to drive transformation into a data savvy enterprise.
Responsibilities:
Build projects and develop data solutions that deliver insights to help grow our businesses.
Work with stakeholders throughout the organization to identify opportunities for leveraging company data to drive business solutions.
Develop data analytics strategy and work effectively in a cross functional team environment.
Mine and analyze data from company databases to drive optimization and improvement of commercial activities, marketing strategies, business processes and strategies.
Coordinate with different functional teams to implement models and monitor outcomes.
Assess the effectiveness and accuracy of new data sources and data gathering techniques.
Develop custom data models and algorithms to apply to data sets.
Use predictive modeling to increase and optimize customer experiences, revenue generation, ad targeting and other business outcomes.
Develop company A/B testing framework and test model quality.
Liaise with stakeholders around the business to improve execution of current projects as well as negotiate novel analytic initiatives, serving unmet business needs and accelerating innovation.
Work with supporting technology teams to improve data mining processes of internal and external data sources.
Key Competencies:
Relationships/Communication - Ability to manage successfully in a matrix organization, ability to drive cross-functional team engagement, and create and sustain internal relationships with franchises and functional teams.
Leadership – Has demonstrated the ability to lead cross functional teams and influence key stakeholders in delivering results.
Strategic Understating - Ability to understand market and business dynamics and develop/adapt strategies to drive growth through market expansion, penetration, and market share gains.
Drive for Results – Be a source of strategic insight and direction in the Business Unit and the Franchise. Ability to inspire the teams to fulfill customer requirements and fuel business growth.
Teamwork – Able to effectively partner across franchises and functions. Able to influence across the organization to drive business results.
Business Savvy - Broad knowledge and understanding of the technical, operational, commercial, and marketing elements of the business and the organization. Ability to make good judgments and quick decisions based on robust business understanding.
Go Ozawa
Medical Device
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