The Compliance officer, based in Tokyo Office, will report locally to the CEO and functionally to the Head of Global Compliance. He / She will be responsible for the following matters:
- Responsible for all compliance matters for Ardian Japan - Manage a broad spectrum of compliance activities including compliance advisory, AML/KYC, compliance review and testing, compliance training etc. - Develop, implement and update relevant compliance policies and procedures - Provide guidance to ensure that business activities are in line with the necessary regulation - Review agreements to ensure that they are compliant with the existing regulatory framework - Liaise with auditors and regulators on compliance related matters including audits, inspections, surveys, regulatory reporting and filings - Other responsibilities include: corporate secretarial matters, cross-border fund registration / marketing matters, other matters as required
The objective of the Supply Chain Program Lead (SCPL) role in Cell Therapies is to plan and oversee the operational execution of the clinical supply network for one or more Cell Therapies programs in clinical development. SCPL will establish stage and scale appropriate supply strategy that bridges seamlessly among Product, Clinical, and Regulatory functions in the Cell Therapies space and ensure sponsor oversight of the Chain of Custody and Chain of Identity (CoC and CoI) that spans the product journey from vein to vein.
The responsibilities of this role include:
Develop and execute vein to vein (or donor to vein) supply strategy for Cell Therapies programs in clinical development. Responsible for supply chain planning, operations, and execution for Cell Therapy clinical programs. Responsible for oversight of CoC/CoI established and maintained by network of internal partners and external vendors. Provide strategic input and subject matter expertise to the development of clinical development plans, clinical protocols, and/or study-specific work instructions or study manuals to support the operational supply strategy for one or more Cell Therapy clinical programs. Represent the Cell Therapies supply chain at the Global Program Team (GPT) and Clinical Subteam (CST). Participate in Study Execution Team (SET), Product Subteam, Translational Subteam, and other cross-functional working groups as necessary to ensure effective planning, execution, communication and escalation throughout the cell therapy product journey.
●Accountable to the GPT for developing operational supply strategy that optimally supports Clinical Development Plan and Translational Engine strategy and overseeing its execution. ・Identify and assess relevant risk scenarios and provide expert recommendations. ・Evaluate critical program needs (internal and external capabilities, resources, skill sets, etc.), and partners with GPT, Cell Therapy Supply Chain, and other stakeholders to ensure needs are addressed ・Communicate program status, cost, risks, and issues to ensure timely decision-making by GPT
●Collaborate with external strategic partners and other vendors to develop and operationalize clinical supply strategy. ・Key point of contact between GPT and external strategic partners/preferred suppliers. Provide program & study-level direction and support to the strategic partners/preferred suppliers for the development of plans including kitting, labeling, storage, and distribution. ・Responsible for ensuring delivery on time, in budget, and with appropriate quality. ・Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues GPT, to governance committees and to senior management when warranted.
【案件の特徴】 ミッションはマイクロソフト製品の販売ではなく、顧客の経営課題に対し、マイクロソフト・ソリューションを活用して解決することです。 先進的なマイクロソフト・テクノロジーを活かした、難易度の高い案件が多いのが特徴です。 「B to C」・「B to B 」のWebサイトやモバイルアプリケーション、社員向けエンタープライズポータルなど、多岐にわたる領域で、UIだけでなくUX設計を含めたデザインニーズが高まっています。媒体は紙、動画も若干ありますが、基本的にはシステム構築に付帯するデザインが主作業となります。
・ コンサルティングサービスの業務委託契約書（準委任契約および請負契約）、秘密保持契約書、誓約書、再委託契約書等の契約書類のレビュー、ドラフティング ・ Drafting and review of Consulting professional service related contracts including jun inin and ukeoi, NDAs, subcontractor and other associated agreements
・ エンゲージメントチームに対する法的リスクに関するアドバイスの提供、契約交渉の支援 ・ Advice and assistance to professional service partners and staff relating to contractual legal risk and negotiating strategies
・ 案件やグローバルポリシーにおけるリスクマネジメント、コンプライアンス、リーガル、サブコントラクターマネジメントチーム等との連携 ・ Liaison with Risk Management, Compliance, Legal and Subcontractor Management teams
・ 契約管理プロセスおよび関連する業務フローのIT化推進による業務効率化の検討、プロセスマネジメント ・ Consideration of options for process improvement of the contract management process, including technological solutions
●OBJECTIVES/PURPOSE The Head of Commercial Analytics & Insights will personally support - as well as lead a team in supporting - Japan’s Pharma Business Unit (JPBU) and Japan Oncology Business Unit (JOBU) ample Business Intelligence needs. This will include, but not be limited to roadmap & capability definition, business analysis, business consulting, requirement gathering, project management and team management.
The role requires a person who can combine an ability to partner with stakeholders at all levels in the organization, who has deep domain experience in Analytics in one industry (not necessarily Pharma) and who is well versed with technology and the platforms and systems that support the business.
●ACCOUNTABILITIES ・As primary IT contact for JPBU’s Commercial leadership, when it comes to their Analytics & Insights needs, you will be responsible for the delivery of dashboards & reports that produce insights into our brands (new launches & existing ones), sales and other relevant KPIs through the use of technology and digital solutions ・Support our business in their data driven strategy by cleansing and maintaining our large commercial datasets (sales, marketing, multichannel, etc.) so that our systems can provide accurate analytics, as well as continuously bring new relevant data sources (RealWorldData, National patient DataBases, etc.) to our DataLake ・Interact & partner with executives and senior managers in multiple JPBU&JOBU departments such as Sales, Marketing, Distribution/Wholesaler Management, Market Access or Patient Advocacy ・Identify opportunities & provide recommendations on how to leverage system resources, reuse local or global solutions and align analytics needs across JPBU&JOBU’s commercial functions by facilitating cross functional, cross regional discussions and forums ・Lead a team of business analysts & data stewards to capture business requirements which later are built into dashboards and transformed to digital solutions for consumption by multiple layers in the organization (from senior leadership to junior medical representative) ・Partner with JPBU&JOBU’s relevant functions to support them in their data purchases to ensure consistency and availability of relevant data ・Aligns global Analytics & Insights technology roadmap with JPBU&JOBU’s Commercial’s needs ・Responsible, together with your team, for the Analytics & Insights workstreams within the Commercial IT Program in Japan (BI, DWH, MDM, R, SAS, WebFocus, HN) ・Accountable to decommission legacy Analytics &Insights platforms
【具体的な職務内容】 - ビジネス機会創出を目的として、市場・競合調査と分析など各種リサーチ実施する。 - 営業チームと協議しながら、マーケティングキャンペーンの立案と実行及び評価、プロモーション活動の推進、新規ビジネス(病院関連)の事業企画、立案、スタートアップの管理を行う。 - Global Medical Devices Marketing Team と連携し、主にMedical Devicesに関する法規制(薬機法、欧州医療機器規則;MDR/IVDR等)、規格、MDSAP等、Globalで使用している販促資料やWeb などの各種媒体、その他、新しいマーケティングツールに関して、翻訳、コンテンツの作成に責任を持つ。