サイトの医薬品製造管理者として、サイトの品質保証、品質管理、GMPコンプライアンス活動を指揮し、責任を負い、これらの分野における支援と専門知識を提供し、かつサイトにおける各品質チームの管理を担います。

薬事、製造、設備、環境衛生安全（EHS）、研究開発、サプライチェーンの各チームと協力し、グローバル基準を満たす最新のGMP（cGMP）を順守し、当社製品が当サイトから供給されるすべての市場において、要求される安全性、同一性、有効性、品質基準を満たし製造されるように品質を保証します。

すべての規制要件とサイト基準が満たされるように品質システムとプロセスが整備され、市場と参天製薬の社内基準を満たす高品質な製品がタイムリーかつ一貫した方法で市場に供給されるようにし、またそのために担当するサイトがcGMPを遵守した状態に維持されるよう管理します。


■品質管理
・他のサイトの医薬品製造管理責任者、品質・安全SME、テクニカルサポート、研究開発、薬事と協力し、効果的な連携とコミュニケーションを図り、必要に応じてサイトの活動をサポートするためのリソースを確保し、継続的な改善を推進する
・グローバル含む他の拠点、すべてのサイトライセンスが維持されていることを担保する
・規制当局とのやり取り、規制当局査察の際の指揮および支援を行う
・各種調査、エスカレーション活動をサポートする
・管理報告プロセスに従って、必要に応じて逸脱やその他の品質およびコンプライアンスに関する事項を日本の品質保証ヘッドおよびその他の品質リーダーに報告する
・コンプライアンス、および効果的・効率的な品質を担保できる組織の構築に向けて、品質マネジメントシステムの枠組みの中で、継続的な改善と目標の文化を推進する
・顧客の要求に従って、テストやその他の活動のスケジュールを監督する
・サイトの各種事業や逸脱を管理し、リスクを評価し、リスクの軽減に関連するアクションと今後の対応策を提言・実行指揮する
・各品質チームが製品サプライチェーンにタイムリーで効果的な支援を提供し、品質と規格に適合した製品を顧客へオンタイムで納品できるようにする


■組織マネジメント
・品質管理（QC）および品質保証（QA）チームをリードし、ベストプラクティス、Quality Principalの実践をリーダーシップをもって行う
・新しい人材の獲得、既存の人材の維持、配下の組織メンバーの適切な教育・育成など、配下チームメンバーの管理を行う


■人材／リソース管理
・配下の組織メンバーが適切なトレーニングを受け、cGMPの原則を理解し、無菌操作に関する訓練と資格を有しているようマネジメントする
・品質資源を効率的かつ効果的に活用する
・組織のパフォーマンスを積極的に評価し、能力開発、指導、育成を通じて組織内の後継者育成を確実に実施する
・品質の組織と全拠点のメンバーに”Quality Culture”を浸透させる
・Quality Principal、インクルーシブな活動、ベストプラクティスに関するコーチングを含むチームメンバーのマネジメント

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

Are you interested in a regulatory affairs role that allows you to mitigate risk and accelerate compliance across the business? If so, this Regulatory Compliance Manager could be an ideal opportunity to explore.

As a Regulatory Compliance Manager Professional, you will be responsible for supporting the implementation and improvement of regulatory processes, assessing risk and proposing mitigation during internal and external audits, as well as providing regulatory overview.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

・Support the development and embedding of risk-based strategies to assure "total" Global Regulatory Affairs (GRA) compliance.
・Support business risk mitigation activities as required and ensure Risk Management
・Compliance Boards are updated centrally and regionally, focusing on key risks and mitigation strategies.
・Key Regulatory interface for certain internal and external inspections and audits of central regulatory affairs (with links to the GSK business quality organization).
・Support the Chair of the Global Regulatory Oversight Committee, represent business GRA compliance as required on business wide or Enterprise wide Compliance/Governance Boards as required.
・Support the generation, interpretation & drive of continuous compliance improvement programs for Global Regulatory Affairs.
・Support the generation of metrics that promote the value of compliance in Global regulatory affairs, including training compliance tracking. Identify and escalate opportunities for improvement Enterprise-wide.
・Support training in internal/external inspections and audits and carry out internal inspections of Global Regulatory Affairs (centrally and locally) as required.

■休日：完全週休二日制, 年末年始

【Job Purpose】
The CPMS Asia/Japan Manager will provide technical therapeutic, and product development support for GlaxoSmithKline projects. Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice of Modeling & Simulation (MS) and optimal application of Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds.

臨床薬理及びモデリング&シミュレーション（CPMS）Asia/Japanマネジャーは、グラクソ・スミスクライン（GSK）の開発品の治療および製品開発について、臨床薬物動態学（PK）、薬力学（PD）を用いて、Modeling & Simulation（M&S）の実践に習熟し、効率的な医薬品開発、リスク管理、承認申請に向けてModel Informed Drug Discovery & Development（MID3）を適用することに貢献します。

【Key Responsibilities】
Work as member of both Asian CPMS and global CPMS teams to develop and deliver Model Informed Drug Development Modelling and Simulation strategies to impact project strategy, decision making and accelerated approvals.
Contribute to the design of an efficient clinical development program and a robust registration package for the Asia region and specifically Japan.
Design the component of the Asia Phase 1 PK/PD strategy and associated study design elements within the assigned therapeutic area(s).
Analyze and interpret clinical pharmacology studies, including those to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics.
Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators.
Innovate through working effectively with colleagues in the department and others such as statisticians, physicians, and regulatory affair staffs.
Promote long term strategic initiatives in the development of innovative MID3 solutions to complex R&D problems.

アジアおよびグローバルのCPMSメンバーとして、プロジェクト開発戦略、意思決定、承認取得の促進に影響を与えるMID3の適用
アジア地域、特に日本における効率的な臨床開発プログラムおよび臨床データパッケージの設計
担当領域におけるアジアの第I相試験の必要要件および関連する試験デザインを提案
PKおよびPDに対する内因性および外因性の潜在的影響の評価を含む臨床薬理試験の解釈
臨床薬理における戦略および結果を社内ガバナンス委員会および規制当局に提示・説明
社内外のステークホルダーと効果的に協力し、変革を推進
複雑な研究開発の問題に対する革新的なMID3を用いた開発における長期的な戦略的イニシアチブを推進

■休日：完全週休二日制, 年末年始

【Job Purpose】
The Japan Medicine Development Lead (J-MDL) is accountable for medicine development in Japan to ensure delivery of differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL serves as the asset level point-of-contact for central MDL, and asset single point of contact to Japan senior management and Japan governance board.

■Key Responsibilities
・Acts as a single point of accountability for all aspects of a medicine development in Japan from initiation of Japan development to launch in Japan.
・Delivers differentiated medicines of value for patients, stakeholders and markets in Japan on time within budget, through an evidence package that supports regulatory approval, market access, and product life cycle in Japan.
・Leads the multi-disciplinary matrix team in Japan (i.e. Japan Medicine Development Team); supports differentiated development for team members; owns the performance of J-MDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-MDT.
・Collaborates with the central Medicine Development Team (MDT) to create strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Medicine Profile. Serves as the asset level point-of-contact for the central Medicine Development Leader (MDL).
・Works closely with the Japan Early Development Leader (J-EDL) as well as Japan Medical Lead (J-MAL) and Japan Commercial Lead (JCL) to ensure a smooth transition.
・Asset single point of contact and spokesperson to Japan senior management and Japan governance board (e.g. Portfolio Investment Board Japan).
・Proactively identifies unmet medical needs that could be addressed through line extensions in Japan.
・Prioritizes and maximizes the asset’s portfolio options including developing multiple indications in Japan.
Increases visibility amongst the external communities (physicians, regulators, patients, payers) in Japan, to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK.
・Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
・Accountable for delivering and managing the asset resourcing plan in Japan. In addition, the JMDL is accountable for managing the asset budget in Japan.

■休日：完全週休二日制, 年末年始

※職務の目的および主な業務内容 Job Purpose & Key Responsibilities※

Purpose:

•Lead GSK Japan cross-functional launch team to develop and implement the launch plan for Bepirovirsen and Linerixibat for Hepatitis B, and Primary Biliary Cholangitis (PBC), respectively

•Member of the Global/Japan cross-functional team shaping global strategy and co-creation of materials

•Understand global strategy and initiatives, as well as local environment and insights in order to develop annual marketing/business plans

•Operationalize tactical plan collaboration with sales team without delay

•Track and understand performance and KPIs

•Achieve target for national sales, profit and promotion budget on a monthly basis

Key Responsibilities:

•Lead the Japan efforts to support the launch planning and commercialization of Bepirovirsen and Linerixibat

•Lead the cross-functional team to ensure alignment across medical, sales, business excellence, pharma technology, market access, regulatory, supply chain, compliance, legal, and finance both in terms of launch plan development and effective implementation

•Represent Japan needs into Global TA to ensure Japan launch is successful including proactive provision of strategic inputs and insights to global. This will include provision of insights to global brand leader and directors to help develop Japan brand strategy and alignment with global brand strategy.

•Build/monitor national quarterly/annual sales forecast/targets and promotional expense plan

•Develop sales materials with MR input to support the key message strategy

•Communicate brand tactics for flawless implementation and motivate the sales team as the brand champion for Bepirovirsen and Linerixibat

•Establish and maintain relationships with KOLs, relevant organizations and other key stakeholders and build/execute external customer engagement plan to understand and shape as appropriate the external environment

•Identify growth and competitive opportunities, including via development and tracking of KPIs

•Escalate and resolve issues including matters linked to performance and governance

•Key member of the Japan Hepatology leadership team

•(After product approval) Spend 25~30% of time in the field and work with cross-functional team (medical affairs, business excellence) to understand customer needs as well as real market issues and highlight evidence needs so that these can be considered/evaluated frequently at key forums and meetings

※Future scope of job and working location will be determined by company.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

【Job Purpose】
The Japan Head, R&D Procurement will be accountable for Japan R&D Procurement capabilities for Clinical, Medical & Regulatory, with accountability for supporting the country implementation of certain category strategies. He/She will also be responsible for supporting local R&D Procurement requirements within Japan for the categories in scope. This will include alignment with the key GSK leaders responsible for these goods & services; the development and implementation of category strategies where it makes sense; the contracting for master/service/product agreements within the categories; the management of supplier relationships that fall outside of the enterprise SRM structure for these categories; and for ensuring the key global and regional suppliers commit to deliver GSK’s performance/quality/financial requirements.

He/She will also be part of Asia R&D Procurement to provide necessary support in other Asian countries beyond Japan region when needed

■Key Responsibilities:
・Manage a spend of ~£50million by creating comprehensive localized sourcing, contracting, and supplier relationship management strategies for the relevant categories.
・Demonstrate in-depth knowledge of the in-scope categories, their relevant industries/markets, and GSK’s forward-looking capability requirements and use this knowledge to engage with senior stakeholders to help shape, assess, and source GSK’s R&D requirements.
・Attract, retain, develop, and grow professional sourcing, contracting, and supplier relationship management talent. This includes developing the broad capabilities, both technical and behavioural, for all direct reports, indirect reports, and matrixed reports to drive continued improvements to team performance.
・Role model and consistently demonstrate GSK values and behaviours, foster the environment of a modern employer and promote GSK network/brand.
・Deliver cultural change to enable an organisation focused on decision-making accountability, quality, speed, performance, results, and collaboration.
・Ensure clarity of roles/job descriptions, expectations/objectives, and development plans for all team members.
・Ensure Master and service-level agreements are strategically aligned with R&D Business goals by engaging all relevant stakeholders in the sourcing strategy and contract management activities and delivering a strategy for most efficient contracting and buying-channel.
・For select suppliers, establish and manage SRM structure aligned with broader R&D Procurement SRM structure.
・Build strategic relationships and ensure the appropriate communication strategy is in place with relevant senior GSK stakeholders; understand business requirements, identify opportunities to create value, position Procurement’s value proposition, and align sourcing strategies to assurance of supply (risk management), compliance, quality, service, cost and innovation.
・Create compelling business cases for change and obtain approval to execute from GSK R&D and/or other support functions (Finance, HR, etc.) senior management; agree how benefits will be achieved and accounted for.

Build strategic relationships with leaders of key suppliers to ensure the value of the supplier-GSK relationship is optimised; account for cross-GSK
requirements in supplier relationships and leverage business review meeting process to drive the relationship.
This role will interact with JET and JET-1 leaders to nurture collaboration across GSK. The role holder will establish connections with senior leaders of key suppliers and influence supplier long term strategy.

■休日：完全週休二日制, 年末年始

We are seeking CRM Tech Lead for Japan Commercial and Medical who will contribute to the success of our Japanese business by leveraging global strategies while focusing on the unique needs of the local market. This role is hired for Business As Usual support for Japan CRM, and potentially, this role will conduct Japan Veeva KT to global commercial central team and being the Japan onsite point of contact to support global central team migrating Japan Veeva to global Vault. The ideal candidate will not only be proficient in CRM functionalities but will also be expected to enhance our Omnichannel and AI strategies using data-driven insights.

■Key Responsibilities are:

・Implement and optimize CRM strategies leveraging global initiatives and cater to the Japanese market.
・Utilize Veeva CRM knowledge to improve customer engagement, sales/medial effectiveness, and business outcomes.
・Utilize CRM data to inform and drive Omnichannel marketing efforts and AI integration (such as MyInsights) implementations with other GSK teams.
・Collaborate with cross-functional teams to integrate CRM solutions with other business solutions and processes.
・Provide insights and recommendations to the business on CRM best practices and innovations.
・Ensure CRM tools and data are leveraged to their full potential to deliver personalized customer experiences.
・Manage CRM-related projects, ensuring they meet business requirements, timelines, and budgets.
・Ensures that technical delivery is fully compliant with GSK Security, Quality and Regulatory standards.
・Ensures continuity of business execution i.e. operational support for relevant applications
・Ensures adherence to GSK Service Management standards and SLAs
Role oversees and monitors the work provided by GSK partners and CWs

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

【Job Purpose】

・Responsible for driving commercial success in Japan LOC by bringing local environment understanding and insights into the shaping of global strategy, pull through into local tactics, and co-creation of materials
・Develop and implement the launch plan and annual marketing/business plan for Belantamab mafodotin (belamaf) for Multiple myeloma (MM) and Momelotinib (MMB) for Myelofibrosis (MF)
・Achieve target for national sales, profit, and promotion budget on a monthly basis through understanding and tracking against performance KPIs

【Key Responsibilities】

・Support Japan launch planning and commercialization of belamaf for MM and MMB for MF:
・Serve on the cross-functional team to ensure alignment across medical, sales, business excellence, market access, clinical development, regulatory, supply chain, communication, compliance, legal, and finance both in terms of launch planning and effective implementation
・Represent Japan needs into Global TA/Brand leaders to ensure Japan launch is successful including proactive provision of strategic inputs and insights to global and alignment with global brand strategy.
・Understand customer needs, market dynamics, landscape insights
・Build and execute external customer engagement plan to establish and maintain relationships with KEEs, relevant organizations and other key stakeholders
・Build/monitor national quarterly/annual sales forecast/targets and promotional expense plan
・Develop sales materials to support the key message strategy
・Communicate brand tactics for flawless implementation and motivate the sales team
Identify growth and competitive opportunities, including via development and tracking of KPIs
・Escalate and resolve issues including matters linked to performance and governance

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

◆海外現地法人の経営管理等
◆海外営業・マーケティング
◆商品開発

※入社後一定期間は国内勤務を経験し、
　海外現地法人（東アジア、ASEAN諸国、メキシコ等）への赴任を想定

■休日：完全週休二日制, 年末年始

•
Accountable for the Quality Assurance department operation and the company’s Quality Management system, drives continuous improvement initiatives, and maintains effective communication with internal and external stakeholders.
•
Ensure that products manufactured at the Fukushima facility are safe, efficacious and perform as intended, and determines whether products conform to specifications, country regulations and industry standards.
•
The position reports directly to Senior Director of Manufacturing & Design Quality, Greater Asia
品質保証部門の運営と会社の品質管理システムに責任を持ち、継続的な改善イニシアチブを推進し、社内外のステークホルダーとの効果的なコミュニケーションを維持する。
-
福島工場で製造された製品が安全で、効能があり、意図した通りに機能することを保証し、製品が仕様、国の規制、業界標準に適合しているかどうかを判断する。
-
本ポジションは、グレーターアジア製造・設計品質担当シニアディレクターに直属する。

Roles / Expectation
•
Develops and maintains plant-wide quality standards, procedures, and processes to ensure compliance with regulatory (local and international), corporate, and business unit requirements.
•
Appointed as Management Representative (MR) and representing management during audit. Lead the Quality Management Reviews, presenting detailed reports on the performance of the quality system and quality objectives to the leaders. Provide actionable insights and recommendations for continuous improvement.
•
Serve as the primary interface between the plant and Divisional, Corporate, and external quality-related personnel, ensuring effective communication and collaboration on all quality matters.
•
Provides leadership in quality oversight and direction, scheduling, decision-making, problem-solving, and team-building capabilities.
•
Prepare the company for audits and inspections from regulatory authorities, ensuring inspection readiness and compliance at all times. Lead audit response and resolution efforts, maintaining a strong track record of successful inspections.
•
Maintain meticulous documentation practices in accordance with regulatory standards. Oversee the company's documentation function, ensuring accuracy, completeness, and accessibility of quality-related records.
•
Plans and manages departmental budget, contributing to the development of overall business strategies.
•
Lead the review of non-conformances, collaborating with the cross functional team to initiate corrective and preventive action plans. Ensure root cause analysis and sustainable solutions are implemented promptly.
•
Provides Quality Assurance oversight for all product lines, ensuring adherence to specifications and effective handling of non-conforming products.
•
Manages customer complaints, implements corrective actions, and communicates effectively with customers.
•
Manages Internal and Supplier audit programs.
•
Supports evaluation projects and new projects by guiding the development of quality plans and executing inspection and testing activities.
•
Participates in steering team meetings to set direction and expectations for resource and process teams, driving continuous improvement and team development.
•
Perform any other tasks as assigned.

役割／期待
-
工場全体の品質基準、手順、プロセスを策定・維持し、規制（国内外）、企業、事業部門の要求事項へのコンプライアンスを確保する。
-
管理代表者（MR）に任命され、監査時に経営陣を代表する。品質マネジメントレビューを主導し、品質システムのパフォーマンスと品質目標に関する詳細なレポートをリーダーに提示する。継続的な改善のため、実行可能な洞察と提案を行う。
-
工場と事業部、コーポレート、社外の品質関連担当者との間の主要なインターフェイスとなり、すべての品質事項に関する効果的なコミュニケーションと協力を確保する。
-
品質監督・指示、スケジュール管理、意思決定、問題解決、チームビルディング能力においてリーダーシップを発揮する。
-
規制当局からの監査や検査に備え、常に検査の準備とコンプライアンスを確保する。監査への対応と解決をリードし、査察成功の実績を維持する。
-
規制基準に従い、文書化を綿密に行う。会社の文書化機能を監督し、品質関連記録の正確性、完全性、アクセス性を確保する。

部門予算を計画・管理し、全体的な事業戦略の策定に貢献する。
-
不適合事項のレビューを主導し、クロスファンクショナルチームと協力して是正・予防措置計画を開始する。根本原因分析と持続可能な解決策が迅速に実施されるようにする。
-
全製品ラインの品質保証を監督し、仕様の遵守と不適合製品の効果的な処理を保証する。
-
顧客からの苦情を管理し、是正措置を実施し、顧客と効果的にコミュニケーションを図る。
-
社内およびサプライヤー監査プログラムの管理
-
品質計画の策定を指導し、検査・試験活動を実施することで、評価プロジェクトや新規プロジェクトをサポートする。
-
リソースチームとプロセスチームの方向性と期待を設定し、継続的な改善とチーム開発を推進するためのステアリングチームミーティングに参加する。
-
その他指示された業務を遂行する。

■休日：完全週休二日制, 年末年始

・PMDA 厚⽣労働省等の規制当局との面談・折衝
・薬事分析（Regulatory Assessment）の実施
・Global PRA（欧州・アジア各国）およびクライアントとの協働
・Global PRA への日本に於ける薬事要件のインプットと協議、協働
・社内他部門との連携と薬事観点のアドバイス提供
・薬事関連資料（各種面談資料、治験届、CTD 等）の作成・作成リード
・新薬申請から承認取得までの各種対応のリード
・新規クライアントに対する、薬事戦略（Regulatory Strategy）の提案やプレゼンテーション
・チームメンバーのスキルアップへ向けたメンター業務

■休日：完全週休二日制

クリニカルオペレーション部門におけるCRAおよびIn-House CRAといったメンバーのラインマネジメント（育成、評価、リソースマネジメント、メンバーマネジメント等）をお任せいたします。
また会社の立ち上げフェーズでもあることから、PRAグローバルと連携し、会社の仕組みづくり、プロセス構築といったタスクフォースにも取り組んでいただくことを想定しております。

【具体的には】
・経験の浅いCRAおよびIn-House CRAの教育・指導を行う
・CRAおよびIn-house CRAといったメンバーが、高いパフォーマンスを発揮し、質の高い業務を行えるようなマネジメント、およびキャリア開発プランに基づく育成を行う
・メンバー個人のキャリアゴールの達成に向けたサポートや、適切なフィードバックを行う
・昇給、昇格に紐づくパフォーマンスのマネジメントを行う
・優秀な人材の定着（retention）、およびクライアントの求める期待以上のサービスを提供できるように、メンバーのworking environmentに気を配りながらマネジメントを行う
・プロジェクトタスク、およびタイムライン管理によって、プロジェクトチームが顧客のニーズに寄り添えるよう、アサインを含めた適切なリソースマネジメントを行う
・他のfunctional managersとのコミュニケーションを取りながら、最適なチーム運営およびメンバーマネジメントを行う
・タスクフォースチームをリードし、仕組みやプロセス改善に向けたイニシアティブを執る
・適切なコミュニケーションによって、チームビルディングを行う
・社内におけるpoint of escalationとして、問題やconflictの改善・解決に取り組む
・PRAのシステムやプロセスに照らし合わせ、自部門のメンバーがコンプライアンスを遵守しているかどうかを確認・評価する
・必要に応じてassessment visitや、bid defense meetingへの参加、またはそれらに向けたサポートを行う
・クリニカルオペレーションのパフォーマンスを最大限発揮し、クライアントに対して質の高いサービスを提供できるよう、クリニカルオペレーションに関わる人材の採用にも携わる

■休日：完全週休二日制

当社の事業拡大に向けて、ラボの立ち上げ、技術開発をお任せいたします。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

・プロトコルの明確化、組入れ基準の決定、患者さんの安全性・適格性の問題を含むプロトコル関連の問題について、プロジェクトメンバーや治験実施医療機関に対し医学的アドバイスを行う
・プロトコル、治験薬概要書、症例報告書の医学的レビューを行う
・プロジェクトチームに対し、疾患領域や適応症に関するトレーニングを提供する
・インヴェスティゲーター・ミーティングに参加する
・有害事象のレビューを行う
・ファーマコビジランス部門と協力して、重篤な有害事象のレビューを行う
・ファーマコビジランス部門と協力し、またはその代理として、累積/類似症例の分析をサポートする
・有害事象コーディングの医学的レビューを行う
・総括報告書とナラティブのレビューを行う
・キックオフミーティング、チームミーティング、クライアントミーティングに参加する
・就業時間以外にプロトコル関連する緊急問題が生じた場合は所定のルールに従ってタイムリーに対応する

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

■ 職務概要
臨床開発プロジェクトの進捗・品質・予算等を総合的に管理するプロジェクトマネジメント業務

・臨床開発プロジェクトのタイムラインの管理
・プロジェクトに関する提案、契約締結
・社内の調整・進捗管理（主に、プロジェクトメンバーとなるCTL、CRAなど）
・プロジェクトの予算管理・調整
・リスクマネジメントプランの作成
・開発戦略提案、ビッドへの参画、契約締結に向けた交渉
・開発他部門との調整、進捗管理
・グローバル治験・アジア治験においては、日本発信のプロジェクトをマネジメント
・他国CPMとの協業

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

■Job Purpose:
As a Financial Assurance Manager, this individual will support internal control over financial reporting (ICFR) assessments throughout our firm. In addition, this individual will support key initiatives to imple-ment, execute and manage the effectiveness of the ICFR Program, acting as a trusted partner and drive awareness and effectiveness of risk management and controls processes in a cross-functional envi-ronment.

■Major Accountabilities:
・Conduct the evaluation and testing of business processes’ key controls and identification of areas of risk, leading the assessment of the adequacy and effectiveness of control frameworks and recommend enhancements
・Prepare the annual internal controls risk assessment including internal and external risk factors, financial statement mapping, controls rationalization/gap analysis, risks identification, key reports and system interfaces, and services organization controls.
・Coordinate the execution of the internal control testing calendar with key process leads and ex-ternal auditors, and ensure adherence to deadlines.
・Coordinates external auditors activities related to Internal Controls, ensuring alignment with the internal framework
・Identify opportunities for process enhancements and work with cross-functional teams to stream-line workflows and improve efficiency, driving continuous improvement initiatives.
・Develop and deliver training programs to promote awareness of internal controls and risk man-agement throughout the organization.
・Foster strong relationships with key stakeholders across the organization to understand and ad-dress applicable risks
・Act as a trusted advisor to key process leads on matters related to internal controls and risk man-agement.
・Leverage technology and data analytics to enhance control monitoring and risk assessment pro-cesses.

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

【Job Description Summary】
To manage business and operational activities of local regulatory writing (RW) to ensure timely production of high quality clinical documentation.
To ensure compliance with global RW strategy and implementation of technical activities & strategies according to internal and external guidelines and business objectives.
To coach, mentor and train less experienced writers.

【Job Description】
■Major Accountabilities
・Business and operational management of local RW.
・Manage quality, timeliness, efficiency and high scientific standards for written documents produced by the local RW; Clinical Study Reports (CSR), Common Technical Document submission documents (clinical overviews, summaries of clinical efficacy and safety), other documents for health authorities (e.g., Briefing Books, answers to questions, PMS and re-examination related documents).
・Act as documentation consultant to other line functions in GDD-J and more widely.
・Lead development of document templates, documentation-related processes and strategies by close interaction with global counterpart.
・Participate in priority setting, workload distribution and resource planning to ensure adequate assignment of writing resource to projects.
・Coordinate outsourcing of RMW activities by acting as liaison between internal vendor management and internal customers
・Contribute to the development of the RW organization through interactions within management team and across functional areas.
・Recruit talent, manage performance (set objectives, review performance and plan compensation).
・Identify training needs to foster high level of performance within RWS. Coach/mentor and/or train less experienced writers.
・Maintain audit, SOP and training compliance.
・Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
100% timely delivery of all training requirements including compliance.

■Key Performance Indicators
・Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics.
・Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators.

■Job Dimensions
・Number of associates:
Can act as operational and functional manager (head) for Regulatory Writing
Indirect: matrix management of cross-functional teams.

・Financial responsibility:
Internal costs in RW and external costs for project related activities in documentation area

・Impact on the organization:
Timely preparation of high quality clinical documents supporting pharma/oncology registrations.
Contributor to cross-functional process improvement.

■休日：完全週休二日制

■Job Description Summary
-Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Lead field medical activities in collaboration with cross-functional teams and mentor other Field Medical associates.

■Major Accountabilities
・Provide excellent coaching for MSL members to continuously improve actionable insight generation and establish a strong strategic long-term engagement with HCP/HCS. Approximately 50% of the MSL group manager’s time should be spent on coaching.

・Collect and generate actionable insights from HCP/HCS/Patients on healthcare ecosystem and treatment landscape both at national and area-specific level, to be incorporated into Novartis launch strategies and tactics

・In collaboration with MSLs and the Medical Lead, creation of field medical strategic and tactical plans (MEEP), aligned with Japan medical franchises and Medical Excellence and Execution. Accountable for execution of plans.

・Create/Drive improved treatment pathways in collaboration with MSLs, Medical Lead and other relevant functions (e.g. V&A, Ecosystem), engaging with National/Local HCP and HCS

・Up-to-date scientific training of field medical team to support timely and robust scientific discussion with HCP/HCS

・Guideline related communication to ensure appropriate positioning and patient access

・Provides holistic view of Japan MSL effectiveness through the development and analysis of KPIs, reporting dashboards, and Japan MSL value communications to leadership; communicates Japan MSL value and impact to the broader organization

・Support RC/IIT

■Key Performance Indicators
・Quality and quantity of field medical activities and actionable insights
・Voice of Customer feedback on scientific quality of MSL interactions
・Customer NPS score in relation to trust and reputation

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

Job Description：
Collect valuable insights through managing primary and secondary research to identify business opportunity, support to structure strategic planning process & brand health governance. Suggest actionable insights from qualitative data, identify trends, assess strategies, competitive intelligence, with the ultimate goal of enhancing customer experiences.

職務内容：
一次および二次調査の管理を通じて貴重なインサイトを収集し、ビジネスチャンスを特定し、戦略的プランニングプロセスおよびブランドヘルスガバナンスの構築をサポートする。定性データから実用的なインサイトを提案し、トレンドを特定し、戦略、競合情報を評価し、顧客体験を向上させることを最終目標とする。

Your key responsibilities：
Your responsibilities include, but are not limited to:
• Lead and interpreting market research data, generating reports, and presenting finding to cross-functional stakeholders as business partner
• Understand business objectives and design surveys to discover prospective customers’ preferences, and market dynamics including internal / external environment
• Provide competitive analysis on various companies market offering, identify market trends, business models, sales and methods of operation
• Newly propose to relevant members (e.g. TA, Cx strategy) business direction through integrated insights
• Track KPI of key brands to assess the progress of strategy
• Develop and execute training programs to improve marketing capability and locally implementing strategic framework

あなたの主な責任
担当業務には以下が含まれますが、これらに限定されるものではありません：
- 市場調査データのリードと解釈、レポートの作成、ビジネスパートナーとして機能横断的な利害関係者への調査結果のプレゼンテーション
- ビジネス目標を理解し、見込み顧客の嗜好や内部/外部環境を含む市場ダイナミクスを発見するための調査を設計する。
- 様々な企業が提供する市場に関する競合分析を行い、市場動向、ビジネスモデル、販売、運営方法を特定する。
- 統合された洞察を通じて、関連メンバー（TA、Cx戦略など）にビジネスの方向性を新たに提案する。
- 主要ブランドのKPIを追跡し、戦略の進捗を評価する
- 戦略的フレームワークを現地で実践し、マーケティング能力を向上させるためのトレーニングプログラムの開発と実行

■休日：完全週休二日制, 祝日, GW, 夏季休暇, 年末年始

【Role Purpose】
The Lead, TA Medical or Associate, TA Medical is accountable for building responsible brand or disease area medical strategy and ensuring its execution in collaboration with MSLs, MSEs and other partners with support from Head, TA Medical, Senior leads, TA Medical and/or Leads, TA Medical. The Lead, TA Medical or Associate, TA Medical is the key project representative to commercial and GDD within Japan, and to global medical outside of Japan.

【Major Accountabilities】
The Lead, TA Medical or Associate, TA Medical is accountable for all of the below items with support from Head, TA Medical, Senior leads, TA Medical and/or Leads, TA Medical.

• Bring clarity to the medical strategy and the tactics in the therapeutic area by their own medical/scientific knowledge/interpretation/judgement and deep understanding of external voice/environment as medical/scientific/clinical research expert.
o Develop outcome-focusing TA Medical strategy aligned with TA strategy from both local and global points of view
o Act as “Medical lead” in the agile project
o Drive the actionable insight cycle by giving regular clear direction to MSLs on activities, messaging, targets, etc., and utilize collected insights to further refine the medical tactics
o Work with PMO to shape the project work breakdown structure for the TA and to identify/secure required resources and budget of the teams
o Input local needs into global strategy and collaborate with global teams on global project
o Develop omnichannel engagement (OCE) plan by conducting omnichannel data analysis in collaboration with OCE capability pool and Medical Science group

• Lead/execute the evidence generation strategy in the responsible therapeutic areas as a medical/scientific/clinical research expert through scientific publications and innovative medical solutions in close collaboration with internal and external stakeholders.
o Plan/lead/execute primary data collection (PDC) and secondary use data (SUD) studies including retrospective researches, prospective researches, biomarker researches, translational researches, database studies, etc. in collaboration with ME&E Dept.
o Plan/execute Integrated Evidence generation Plan (IEP) by leading cross functional team

• Provide training for the organization he/she belongs to by leveraging highly advanced medical/scientific/clinical research expertise in the therapeutic area.

• Work as Patient Engagement Liaison (PEL).

■休日：完全週休二日制