Listing

DESCRIPTION
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies is recruiting for a Clinical Data Manager (CDM) Specialist. This position can be located in Spring House, PA; Raritan, NJ; Titusville, NJ; Shanghai, China; Tokyo, Japan; Beerse, Belgium; Leiden, Netherlands; Mumbai, India; High Wycombe, United Kingdom; or Basel, Switzerland. Remote locations within North America, Asia, and Europe may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Clinical Data Manager (CDM) Specialist will be the data management expert who will perform scientific complex clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This individual will be a key contact between the SRP and SRS and the other data management functions in order to support flawless data management execution. This position will contribute or take a lead in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.

The CDM Specialist will provide support for the SRPs and SRSs of the program you are assigned to. Tapping into technical and clinical expertise, collaborate with the SRP, SRS and the study team members when implementing the data management related activities for protocols, with focus on the more complex indication and therapy related elements of the study. As such, you will review all necessary data flows, the Data Management Plans and perform continuous complex data review activities on the studies in your program. The CDM Specialist will work independently, have no direct reports and work will be reviewed with the Data Management Leaders (DML) or immediate manager as needed during major deliverables. The CDM will provide coaching on trial level responsibilities and may delegate work to CDM’s and Senior CDM’s.

Primary responsibilities:

Involvement in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
Take a leadership role with SRP/SRS to establish, align and confirm complex scientific clinical data review expectations for assigned trial(s).
With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
Review content for Electronic Code of Federal Regulations (eCRF) and other data collection tools.
Establish conventions and quality expectations for clinical data.
Set timelines and follow‐up regularly to ensure delivery of all relevant Data Management milestones.
Identify and communicate ways to improve deliverables.
Review complex scientific clinical study data, manages CDM and SRP/SRS related queries in Electronic Data Capture (EDC) system and collaborate with SRP/SRS. Involvement in other review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation).
Lead and/or attend meetings, as appropriate.
Create the trial level or disease area Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Review related clinical data management documents. Ensure compliance with regulatory guidelines and documentation requirements.
Ensure real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.
Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
Identify and participate in process, system, and tool improvement initiatives within Data Management.
Lead or participate, depending on the complexity of the project, in implementing process, system, and tool improvement initiatives within CDM.

DESCRIPTION
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Clinical Data Manager . This position can be located in Spring House, PA; Raritan, NJ; Titusville, NJ; Shanghai, China; Tokyo, Japan; Beerse, Belgium; Leiden, Netherlands; Mumbai, India; High Wycombe, United Kingdom; or Basel, Switzerland. Remote locations within North America, Asia, and Europe may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Senior Clinical Data Manager (CDM) will be the data management expert who will perform scientific complex clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This individual will be a key contact between the SRP and SRS and the other data management functions in order to support flawless data management execution. This position will contribute or take a lead in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.

The Senior CDM will provide support for the SRPs and SRSs of the program you are assigned to. Tapping into technical and clinical expertise, collaborate with the SRP, SRS and the study team members when implementing the data management related activities for protocols, with focus on the more complex indication and therapy related elements of the study. Review all necessary data flows, the Data Management Plans and perform continuous complex data review activities on the studies in your program. The Senior CDM will work independently and has no direct reports. Work is reviewed on an ongoing basis with the Data Management Leader.

Primary responsibilities:

Involvement in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
Take a leadership role with SRP/SRS to establish, align and confirm complex scientific clinical data review expectations for assigned trial(s).
With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
Review content for Electronic Code of Federal Regulations (eCRF) and other data collection tools.
Establish conventions and quality expectations for clinical data.
Set timelines and follow‐up regularly to ensure delivery of all relevant Data Management milestones.
Identify and communicate ways to improve deliverables.
Review complex scientific clinical study data, manages CDM and SRP/SRS related queries in Electronic Data Capture (EDC) system and collaborate with SRP/SRS. Involvement in other review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation).
Lead and/or attend meetings, as appropriate.
Create the trial level or disease area Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Review related clinical data management documents. Ensure compliance with regulatory guidelines and documentation requirements.
Ensure real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.
Identify and communicate lessons learned, best practices and frequently asked questions at the
trial level.
Identify and participate in process, system, and tool improvement initiatives within Data Management.
Lead or participate, depending on the complexity of the project, in implementing process, system, and tool improvement initiatives within CDM.

DESCRIPTION
【職務内容】

特定保守管理医療機器のテニクニカルサポートとして、営業部と連携し機器の安定稼働のためのサービス業務全般を行う。

機器トラブルに対する電話あるいはオンサイトでのトラブルシュート、病院等オンサイトで機器据付、修理、保守点検のメンテナンス業務、引上げ修理の修理取次業務、機器の適正使用の啓蒙活動や、保守契約等のサポートを行う。

■機器のトラブル対応：修理受付、見積作成、修理作業、修理箇所分析（含：製造元とのコミュニケーション）

■機器の出荷指示、搬入、据付、納品作業

■引上げ修理の取次（代替機手配、工場とのコミュニケーションなど）

■機器の定期点検

■作業報告書・修理報告書の作成、データベース入力

■営業部への技術サポート、顧客対応サポート

■作業手順書作成・管理

■代替機器管理、物品管理

DESCRIPTION
We are currently recruiting for a Sr. Analyst, Health Care Compliance to join the Health Care Compliance Global Operations, within the Compliance Technology & Integrations (CTI) team.

You will report directly to the Manager, Global Operations, CTI (APAC) and will have responsibility for partnering with fellow Global Operations team members, Third Party Ethics and Compliance (TPEC) and Health Care Compliance Specialists and Officers. Collaboration with sector Corporate Business Technology (CBT) and Business Unit Information Technology (BUIT) partners is vital to implement plans for global or regional HCC innovative solutions to support key HCC processes such as third party intermediary due diligence, risk assessment and management, monitoring, transaction management, transparency reporting, and HCC document management.

KEY RESPONSIBILITIES:

Provides input into the design, implementation, and maintenance of compliance related solutions to support the ASPAC region and, in certain instances, on a global scale. This includes solutions that support HCC activities and approvals, ensuring adequate documentation to meet compliance obligations and reporting requirements.
Analyzes problems with root cause analysis, requirements, opportunities, and challenges across HCC-relevant processes and systems, using an understanding of associated compliance risks and underlying business drivers
Partners with Health Care Compliance team members, as appropriate, to ensure that systems and related processes meet policies, guidance, and regulatory requirements
Partner with other functional areas such as: Global Data Enablement (GDE), Data Science (DS) TPEC, CBT, BUIT, Global Assessment and Consulting Services (GACS), Global Transparency Reporting (GTR), Global Policy, Training and Communication (GPTC), Privacy, etc. on tactical execution, and implementation of technology and data initiatives within ASPAC and, in certain instances, on a global scale
Execution of day to day business compliance results through implementation of the CTI strategy, across sectors, working closely with Health Care Compliance Specialists and Operating Company employees

DESCRIPTION
Position Summary:

Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

Principal 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.

• Responsible for delivery on established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.

• Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.

• Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.

• Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.

• Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.

• Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.

• Exemplary customer focus with vision to drive solutions

This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Principal Relationships:

This position reports to Manager, Site Contracting

Internal:

• Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties

External:

• Clinical Investigator Sites

• Commercial Suppliers

• Clinical Research Organizations (when applicable).

DESCRIPTION
(Position Summary)

Develop pricing strategy of responsible products
Responsible for material development of New Drug Price Application by leading xfunctional team and the negotiation with MHLW as a company representative
Calculate the expected new drug price of responsible products for BP/LRFP/BD/R&D decision
Conduct a regular calculation/assumption/assessment of price revision, repricing and PMP return for BP/LRFP
Participate in JCoT as a core member to provide input of pricing needs to achieve the target price
Contribute to discussions in industry association activities and collect relevant information

DESCRIPTION
(POSITION SUMMARY)

Responsible for Pricing and Reimbursement of all Janssen products, building the pricing strategies, price negotiation with MHLW, and price revision
Responsible for pricing strategy for company decisions (BP/LRFP/Developmentdecisions)
Contribute to and lead the discussions in pricing related industry association activities
Price negotiation with MHLW

Responsible for price negotiation of all products with MHLW
Support team members directly responsible for price negotiation and lead them to success
Building the pricing strategy

Build pricing strategy that maximizes the value of pipeline products and BD projects
Provide J-CoT (local x-functional team) with input of pricing needs to achieve the target price that maximizes product values at the team discussion (including input on IEGP)
Price revision

Maintains optimal prices, reimbursement of all products
Provides MC/BUs with input of the risk/timing of re-pricing (MER/DCR/ICR)/PMP return for BP/LRFP
Communication with stakeholders

Lead the process of making alignment with global/AP region for the pricing strategy and plan
Support explanation of team member's price strategy to global/AP region
Discuss the market access strategy in cooperation with IMAT members (VE&A, PID and Policy)
Industry activities

Contribute to and lead the discussions in pricing related industry association activities

信頼性保証部安全管理グループにおいて、法規制や社内規定(J&J Standard等)の遵守及び品質マネジメントシステムに基き、日本の市場における製品に関する不具合、安全性に関する情報（安全管理情報）を収集し、顧客、行政に対して適切な情報提供または報告を行なう。
また、品質事象に対して、安全性の評価と適切な安全確保措置の策定を実行する。

・薬機法、QMS、GVP省令ならびにGVP手順書に基づく安全管理情報の収集、評価、安全確保措置の立案の実施（学会、文献、規制当局、業界他社からの安全管理情報の収集、評価、安全確保措置の立案業務等）
・規制当局への不具合・有害事象報告、国内・外国措置報告
・J&J Global Standard 、QMS、GVP省令および関連法規に基づく安全管理情報システムの構築・維持・改善
・添付文書の作成、維持、管理、Web siteへの登録
・薬機法、GPSP省令ならびにGPSP手順書に基づく製造販売後調査等業務の実施（製造販売後調査票の回収、確認、評価、記録、業務進捗管理等）
・規制当局への年次報告、再審査申請
・GVP業務、GPSP業務に関する自己点検、教育訓練の実施
・規制当局、関連学会、業界との連携、対応

このポジションは、SK-II東日本営業担当およびSK-II商品を販売する店舗のストアマネージャー（店長）の店頭活動を支えるべく、データの整理やレポートの作成、契約書、資産や経費の管理、その他事務作業を行うポジションです。各営業担当やストアマネージャー社員の窓口として、日々の営業活動に付随するアドミニ業務・管理業務について主体的にかかわり、彼らがコアワークである営業及び店頭活動に集中し、より多くの時間を割ける環境作りをサポートする。

売上、会員データ、得意先ごとのデータをまとめ、レポートとして営業チームメンバーに配信し、営業活動の後方支援を行う。目標に対する進捗、ビジネス状況をまとめ、ビジネス機会の発見につなげる。
100社を超える得意先企業との契約書をマネージャーの指示のもと押印、発送業務を行い、それらを遡れるように適切に管理する。
経費管理を行い、予算に対する進捗をトラッキングの上、情報共有する。
店頭の資産（什器、タブレット等機器など）を設置費用明細書等関連する資料をもとに資産登録し、管理する。
営業担当が得意先へ支払い処理を行う際に、資料作成サポートおよび予算管理を行う。
営業が各種購入発注や作業明細書を発行する際のサポート。

【仕事内容】
このポジションは、弊社のグローバルスキンケアブランドである、SK-II商品のトータルサプライチェーンを戦略的に構築・運営・最適化することにより、SK-IIの利益成長・売上伸張を最大化することがミッションとなります。各種データ分析及びその分析に基づいた各プロジェクトをステークホルダーを巻き込み、推進することで、SK-IIのビジネス及びサプライチェーンの両面を強化し、SK-IIビジネスの売上・利益向上に貢献いただきます。なお、所属する職種は生産統括部門となります。
【具体的な仕事内容】
• SK-IIの在庫・輸送コスト等のサプライチェーンKPI、および新規顧客数・売上といったビジネスKPIを改善、推進していくためのデータニーズを特定および文書化する。
• 各種ツールを用いて、データの可視化を行い、データに基づく正しいビジネス理解およびプロジェクト実行に繋げる。
• データに基づき、ビジネス価値を高めるインサイトの特定・生成。
• ビジネスに必要な各種データの維持/管理/体系化。
• サプライチェーンおよびビジネスのKPIが目標通りに達成されない場合、その根本原因の特定。
• ビジネスパフォーマンスKPIに関する他部門との協働による計画・実行。
【担当いただくデータ分析例】
• SK-II新規ユーザーの拡大・獲得に向けた分析
• SK-II既存ユーザーのリテンション向上に関する分析
• P&G流通センター・ロジスティクスセンターにおける不採算在庫の削減方法に関する分析
• 輸送コスト削減に関する分析
• メディアおよび消費者への影響に関する分析
担当いただくプロジェクトは、所属するチームメンバーだけでなく、マーケティング、営業企画部門等SK-IIの各部門と協業しプロジェクトを推進していきます。

Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!

Procurement is strategically integrated in the Supply Chain as a key driver of business value – our organization’s vision is to “Partner to shape supplier solutions that transform healthcare.” Johnson & Johnson spends approximately $30B annually across the globe on goods and services. Our procurement professionals work as highly respected partners internally and externally to create and implement strategies and processes that support the business in bringing important health and personal care solutions to people around the world.

Procurement uses the supplier base as a source of innovation by developing closer and more collaborative relationships, and strongly supports sustainability and supplier diversity on behalf of Johnson & Johnson. These creative solutions are facilitated by Procurement through key capabilities, including deep supply market understanding; actionable insights and knowledge; and processes & technology management in order to ultimately accelerate growth & innovation, deliver value for our spend portfolio, and enhance reputation & manage risk. Johnson & Johnson Procurement considers people and talent with diverse perspectives as critical to achieving its vision.

The Procurement Leadership Development Program (PLDP) Internship is a 12-week program that encompasses functional & professional development, as well as completion of challenging project(s) that deals with strategic business initiatives. Interns will have a formal mentor and may participate in organized activities, including sector immersion events, leadership training and local community service projects to understand the company culture and career opportunities.

この度はエムスリーに興味を持ってくださりありがとうございます。

「採用直結型エムスリーウインタージョブ(2days)」に参加を希望される方は、エントリーをお願いします。
エントリー後、事務局から次のステップなどの詳細をご連絡させて頂きます。
（履歴書・ESを添付していただく項目があります。）
※「サマージョブ参加者」や「サマージョブエントリー者(非参加者)」もウィンタージョブへのエントリーが可能です。

■■VALUE QUARTET■■
この夏、高評価を博した 『VALUE QUARTET（バリューカルテット）』のウィンターバージョンを開催決定いたしました！
2daysで「以下4領域(カルテット)の仕事を体感できるGDプログラム」や「現役エース社員を交えたフランクなトークセッション」などを企画しています。

１．戦略系コンサルティングファームの「戦略立案」
２．投資銀行の「M&A」
３．ITメガベンチャーの「新規事業開発」
４．総合商社の「グローバルビジネス」
　
GDプログラムについては、エムスリーのビジネスに関連する4領域の2つの課題についてディスカッションし、チームで導き出したソリューションをエムスリー経営陣へプレゼンしていただきます。
(※サマージョブとはGDのお題は異なります。)

エムスリー役員をはじめ、戦略コンサルや投資銀行出身の社員が、みなさんのアウトプットをビジネスレベルで評価します。