求人情報一覧

職務内容 医薬品（注射剤）包装業務 - 上記製造業務に付帯関連する業務（日々の業務報告・トラブル対応・準備・片付け・清掃・改善活動など） ※業務具体例※ 包装機器の操作およびマニュアルでの包装作業 包装機器及び包装室の5S（整理/整頓/清掃/清潔/躾)活動 製造にかかわるドキュメントの制改訂などのパソコン業務

製剤設備の予防保全、設備のメンテナンス計画の立案及び実施 製剤製造設備のトラブル時の修理、工程改善活動 製剤製造設備の老朽化による設備更新業務 クオリフィケーション、バリデーション、キャリブレーションの実施および管理

職務内容 ・プロモーション資材、D2Dイベント関連資料の作成 ・D2D イベント企画の推進・運営 ・製品情報問い合わせ窓口 ・学術情報の整備 ※D2D：Doctor to Doctor 入社後の仕事内容（イメージ） ・プロモーション資材、D2Dイベント関連資料の作成：特に当社主力製品関連の資材作成中心 ・D2D イベント企画の推進・運営：学会共催セミナー、当社主催オンライン講演会実施にあたり、演者、座長との交渉、調整など ・学術情報の整備：当社製品のFAQ整備

■募集背景 JMDCは、健診結果やレセプトなどの医療ビッグデータを独自にデータベース化し、製薬会社に提供しております。 製薬会社での医療ビッグデータの利活用が拡大する中で、JMDCに対して、マーケティング精緻化／ R&Dオペレーション改善／データベース研究／新ヘルスケアサービス企画など、データを活用した新しい側面からのビジネスインパクトの創出に向けた相談が増加しています。 この流れを踏まえ、JMDCでは、コンサルタント／医師／データサイエンティスト／エンジニア／プロダクトマネージャーなどが専門性を結集して、製薬企業の課題に対してソリューションを提案・実行し、そのソリューションを踏まえて新規事業化していく部署を立ち上げました。その部署をリードする事業責任者候補を募集しています。 ■仕事内容 製薬会社と、医療ビッグデータを活かした新しいビジネスインパクト創出の可能性を議論し、それに対してソリューション提案・具体化していく中で、JMDCの新規事業として事業化していくのをリードして頂きます。 外資戦略コンサル会社で経験を積んだ役員が事業の立ち上げを牽引し、JMDC社内の医師／データサイエンティスト／エンジニア／プロダクトマネージャーなどの専門家とも連携できる環境で、事業の責任者として、事業戦略・計画／顧客開拓／ソリューション提案／メニュー開発／デリバリー責任を担って頂きます。コンサルとしてのスキルを活用しながら、医療ビッグデータやヘルスケア新規事業立ち上げという新しい強みを身に付けることができる非常におもしろいポジションです。 ■具体的な業務内容 JMDCの医療ビックデータ・各種専門家・プロダクト等を活用し、製薬会社の課題を解決するソリューションの新規事業化を牽引します。 顧客の製薬会社を訪問し、マーケティング／研究開発／メディカルアフェアーズ／営業／マーケットアクセスなど幅広い部門の顧客開拓を推進します。それらに対して、データ活用のコンサルティング提案を行い、プロジェクト獲得とデリバリー管理、そこから得られる示唆を用いた新規事業化まで担います。 製薬業界へのビジネス全般の担当役員や、JMDC内のコンサルティングファーム出身者とも連携し、様々な知見をレバレッジして事業運営できる環境です。 テーマ（例） データを活用した製薬の臨床試験の効率化サポート 他社との連携を通じた新しいヘルスケアデータの収集・活用の企画 グループ会社のデータや技術を活用した製薬向け新規事業推進 製薬企業内でRWDを最大限活用できる専門組織構築サポート データを活用した導入候補パイプラインの評価 この仕事で得られるもの 事業責任者の経験：新規事業の立上＆運営を担い、事業成長を目指す経験を積めます。 製薬業界の変革経験：医療ビックデータを活用した製薬のビジネスモデルの変革を経験できます。 医療ビックデータの知見：データ内容のみならず、ビジネスインパクトの創出方法など最先端の知見を蓄積できます。

【職務内容】 ヘルスケア／医療・介護分野で事業展開している企業や、当該領域への進出を検討している企業に対し、経営・事業戦略の策定から実行支援まで、一貫したサービス提供を行います。シンクタンク部門とも連携し、最新の技術・社会動向も取り入れながら、日本のヘルスケア産業を活性化させることをミッションとしています ◇主なクライアント 医療ヘルスケア業界の中堅～大企業、バイオベンチャー、新規参入企業、中央官庁/自治体　など幅広いクライアントに対してサービス提供します ◇具体的には ・ヘルスケア業界の事業戦略策定 　－最先端の技術（再生医療/遺伝子治療、医療ロボット、デジタル治療など）・社会動向を踏まえた事業戦略（コロナの影響、高齢化など）、マーケティング・営業戦略、海外進出支援戦略等の策定・実行支援 ・異業種からヘルスケア業界の新規参入支援 　－技術的な強みを活用し、ヘルスケア産業への参入を検討している企業に対するビジネスモデルの構築・実行支援を実施。必要に応じ、ジョイントベンチャーの設立等、実際に事業が動き出すまで一貫してサポート ・ヘルスケア業界におけるデジタル化推進 　－医療ビッグデータ、AI、IoT、PHR、デジタル治療、オンライン診療などをキーワードとして、各種メーカー、医療機関、政府/自治体向けにデータ構築からインプリ、実証まで一貫とした支援 【プロジェクト事例】 ・医療機器メーカー　欧米への販路拡大支援 ・化学品メーカー　　医療ヘルスケア領域への新規進出に関する開発戦略構築支援 ・製薬メーカー　　　再生医療に関する価値評価、マーケティング支援 ・中央官庁　　　　　2040年など未来の医療将来像の探索　 ・バイオベンチャー　デジタル化の推進の戦略構築、実行支援 【募集部室】 コンサルティング事業本部　戦略コンサルティングビジネスユニット ヘルスケアコンサルティング室

概要 ・ミッション 製薬企業における営業組織のDX支援を通じて、製薬業界の構造変革に大きく貢献すること ・所属フィールドDXグループ（将来的には他事業兼任の可能性あり） ・担当業務 新規配置の責任者として一人業界全体のDX推進にた事業展開を推進していただきます ー複数のプロジェクトのリーダーとしてプロジェクト運営、及び、更なる価値提供に向けた提案と実行を担い、顧客サクセスの実現を推進していただきます ー担当プロジェクトに関してはチームをマネージし、高品質/高生産性のサービス・デリバリー、及び、クライアントへの適切な提案と実行をリードしていただきます ークライアントのマネジメント等への報告に加え、重要な案件に関しては、社内外チームのワークマネジメント、データ分析・示唆基礎等も行っていただきますー価値拡大に向けて、医師ビッグデータ等のアセットを提供してください活用した、新規サービス開発、及び、既存のサービス改善を社内外メンバーを巻き込みながら推進していただきますー立ち上げ直後の配置を踏まえての成長コア事業組織今後のために、オペレーション標準化、ナレッジ活用、育成や評価等の組織設計等、組織力強化に向けた対話を推進していただきます。

OBJECTIVES/PURPOSE Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements Main objectives (key services) Technology selection Review Capacity Modeling developed by Engineering company Engineering and Equipment Design Safety engineering design and management Recommend strategic preparation of project for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions ACCOUNTABILITIES Acting as Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment. In detail, He/she will: Report to the engineering manager. Develop and maintain process equipment concepts and engineering scope based on approved budget and schedule. Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards and define the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment. With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment. Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Black Utilities Operations, Maintenance, Calibration, Reliability, Automation.

・Global Corporate Affairs（広報）部門のサポートを担当します。 ・GCA（特に日本）のビジネスを深く理解し、ビジネスの問題を解決するためのデータテクノロジーのソリューションを提案します。 ・DD＆T内の関係者と協力してGCAが使用するアプリケーションやソフトウェアの適切な管理とサービス提供をします。 ・As a member of Global Corporate Affairs (GCA) – Data, Digital & Technology(DD&T) in Japan, develop and maintain effective working relationships with GCA stakeholders in Japan to promote their use of data, digital and technology and support the creation of new business processes and improve existing business processes. ・ Develop a deep understanding of GCA's business in Japan and execute product delivery service within the portfolio. ・ Responsible for the day-to-day development and alignment of delivery to the strategic vision ・ Focus on delivery, release plans, and communication progress to stakeholders. ・Work with Global DD&T stakeholders to support the deployment of global platforms/applications. ACCOUNTABILITIES: GCAが主管及び利用するシステムのサポートをします。具体的には以下の業務を担当します。 1) 社内ユーザへのSharePointトレーニングの提供やサイトの設定サポート等 2) 社外Webサイトのコンテンツ作成や修正 3) 寄付管理システム、メールマガジン配信サポート、社内コミュニケーションツールのサポート 4) グローバルプロジェクトへの参加 ・Responsible for delivering operations of the products used by GCA ➢ Support internal website on the Microsoft SharePoint platform and corporate external website on CMS platform. Including (but is not limited to) maintenance, demand management, functional improvement, content editing. ➢ Provide the SharePoint training to end users and advise them how to set up collaboration site. ➢ Create/edit contents(Publish press releases and update site contents) ➢ Support donation management system, email delivery/analytics application, internal social networking service, etc. ・ Participate the global project meetings when it is required. ・ Make sure the team correctly understands the requirements. ・ Support the team in collecting ideas and setting priorities for prototyping and development. ・ Corporate with global development team and solved issues together. ・ Provide IT supports for employee events organized by GCA.

OBJECTIVES/PURPOSE Responsible for designing, developing, and maintaining electrical and automation systems. The successful candidate will work closely with cross-functional teams to ensure that all electrical and automation systems are in compliance with regulatory requirements and industry standards. Project engineering for the Strategic Automation Pillars in the areas of: Automation Security & Integrity Engineering Automation & Control Systems Data Integrity Automation Cybersecurity Automation Solutions & Systems Engineering Functional setups & architectures of systems & components Supervisory Control Structures & Data Mgt. Automation Data Engineering Standard Automation Integration Layer (Shopfloor Systems & Data Integration) Data Channels, HMI, displays & Visuals Historization Automation Data Governance Engineering Data Structures & Contextualization Use Case Owner Liaison Mgt, Technical2Business (and vice versa) translation ACCOUNTABILITIES As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems meet regulatory requirements, client specifications, and industry standards and define the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals.

OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting.

As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities* in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems** meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. * Automation Security & Integrity Engineering Automation Solutions & System Engineering Automation Data Engineering Automation Data Governance Engineering **

OBJECTIVES/PURPOSE Deliver optimal designs, operating procedures and maintenance programs for GMP and non-GMP Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Maintain accurate, consice, effective, up to date operating procedures and maintenance plans for Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Drive continuous improvements through defect elimination in System Design, Operations and Maintenance program and processes Support Sustainability initiatives related to Plant Utilities Systems (e.g. energy, water, waste reduction) ACCOUNTABILITIES Acting as a Plant Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for utilities (black and clean) and sustainability related activities. In detail, He/she will: Report to the Engineering Manager. Develop and maintain utility concepts and engineering scope based on the approved budget and schedule. Ensure that all utility systems meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with the external design company on the procurement strategy and procurement packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Manage the resolution of technical issues.

R&D Finance Japanは日本のR&D部門のビジネスパートナーとして、 ①研究開発費の効率的な実行と柔軟な予算配分を考えながら、限られた予算の中で研究開発課題を最大限に進めることで、患者さんに貢献していただいたこと ②財務データの分析を通じて徹底的に得られた知見を研究開発部門に伝えることにより、効率事業運営やコスト競争力の強化に貢献していること ③ファイナンシャルコントローラーとして内部統制の強化に貢献している ミッションとしています。 そして ①R&D部門から信頼されるパートナーとなること ②事業環境の変化やビジネスニーズを先取りして行動できる「Agility」の高いチームとなること ③R&Dファイナンスを経験すればどこでも使えるようになること を目指しており、その一翼を担ってくれる方にチームに選んで頂きたいと考えています。 ＜主な業務＞ 1. R&D部門（研究、薬学、開発等）のパイプラインコストの予算管理 2.研究開発部門の組織運営費の予算管理 3. POC＆C達成後の開発課題の経済性評価 4. 研究開発部門の会計・税務・内部統制業務関連

医薬品等（低分子医薬品、バイオ医薬品、再生医療等製品、医療機器等）の日本における承認取得後のCMC薬事に関連する下記業務 申請戦略・申請計画のCMCパートについて立案・遂行 当局相談に係る戦略策定及び遂行 製造販売承認申請業務（CMCパート） 導入案件のCMC薬事関連の評価

ACCOUNTABILITIES The role is accountable for the overall quality strategy and quality management system of commer-cial vaccines operations and supplies in Japan. The Head of commercial Vaccines Quality is respon-sible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and compliance to global standards and overall Hikari Site Standards. The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and main-tains good day to day collaboration between the 2 site quality organizations. Ensures that new/revised quality system requirements are deployed to the site timely. Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes. Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures are in place when applicable. Responsible for Quality Control testing and sampling for commercial vaccines (Bulk Drug Substance and Drug Product (BDS, DP)) and partners with other laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Moni-toring, Raw Materials) Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities. Development and refinement of groups’ specific quality systems and procedures. Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs. Living values and fostering a Quality Culture culture of trust and and speak up culture within the team. Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise. Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification) Responsible for site specific QMR management and gathering of APQR data. Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc. Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes. Oversight of execution of product disposition (drug substance). Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes. Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies. Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group. Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global VBU organization. Responsible for budget planning and managing expenses and for timely hiring, training and devel-opment of qualified staff to ensure effective execution of roles and responsibilities, GMP compli-ance, and attainment of operational and development goals. DIMENSIONS AND ASPECTS Knowledge and experience of Biologics manufacturing Knowledge and understanding of Health Regulations applicable to local and other markets supplied Knowledge and understanding of industry, scientific and regulatory trends, established prod-ucts portfolio and market conditions to evolve regulatory and quality profile Strong analytical and problem-solving skills (preferably Lean & 6 Sigma background). Leadership Ability to lead a Quality organization of internal manufacturing with full accountability for all aspects of performance of respective site (Customer Service Levels, GMP compliance, EHS compliance, Opex Cost Savings, lab transformation, People Culture & Change) Ability to build a customer & patient-centered, best in class organization, develop diverse talent and elevate organizational performance Ability to make and recommend Quality decisions impacting Market Actions etc., enabling to deliver on its commitment to put patients first and build trust with society Decision-making and Autonomy An active member of Site Leadership teams and vaccines quality teams Responsible for decision making that balances progress on global initiatives with local priorities Responsible for Vaccines Quality governance (Quality Councils / Management reviews) Responsible for active and timely Incident notifications and associated escalation activities DOA limits to be defined in line with new TMAP Interaction Key stakeholders include: global & Japan VBU, Global Manufacturing and Suplly site Quality, Procurement, Supply Chain, Regulatory Affairs. Local Board of Health Agency, National Control Laboratory

Manager, Japan IP will develop and provide IP strategy and direction in the assigned projects / tasks, especially relating to DD&T field in or across Therapeutic Areas, in Japan IP. You will contribute to global TA support activities, especially relating to DD&T, as part of Global IP TA or Product team on the matters delegated by the team leader (Director, Japan IP). You will serve as a strategic advisor in DD&T related projects within and beyond IP department, and while acting as a primary point person for IP-related matters in DD&T field for select internal communication channels, provide valuable support to enhance DD&T capabilities of Japan IP. How you will contribute: In consultation with the supervisor, develop and implement IP strategies by itself based on region and local needs, including exploring any Business Development (BD) opportunities on the matters delegated by its supervisor, involving relevant stakeholders. As a member of the team, contribute to develop and conduct operational excellences at Japan IP. As a member of the team, contribute to develop and implement short-term and mid-to-long term goal of the team, which covers both activities and budgets Develop human network and find key stakeholders outside IP such as the counterparts at R&D and Commercial functions Develop solutions and resolve problems in the scope of the assigned responsibility, where relevant legal precedents in the area of IP may not exist and laws or regulations are ambiguous Support global IP activities such as TA activities, litigations and business development in the scope of the assigned responsibility Understand the Company’s current and planned business activities, products, facilities, customers, competitors, markets and functions in order to identify relevant legal trends, laws and regulations relating to the assigned tasks. Support and contribute to the external affairs in the regional IP industry groups and attorney associations in Japan Effectively work with outside counsel providing additional legal services relating to IP, and monitoring and controlling fees and expenses in the scope of the assigned tasks.