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

◆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

■職務内容の詳細
・顧客に対する提案やグランドデザイン(ゴールと進め方の定義)の実施
・プロジェクトのリーディング、マネジメント
・事業企画から事業開発
・運営までの一連の新規事業開発の主担当 ・顧客側の立場でのプロジェクト推進支援（PMO）

■休日：完全週休二日制, 土, 日, 祝日, 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

■ 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 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 Summary】
The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or multiple compounds. The JPCH closely works with Japan Project Head (JPH) as well as Global Program Clinical Head (GPCH) and inputs the risk benefit assessment for the program(s), and as the member of Global Clinical Team(s) (GCT) provides the inputs regarding the design, implementation, and execution of a clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view. The JPCH may contribute to disease area strategy.

■Job Description
１．Is an extended member of the GCT as representative of Clinical Development Japan (CD-J)
２．Is a member of JPT and drive the clinical development in Japan
３．Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD
４．Post-DDP, lead the development and execution of Japan clinical strategy. Provides Japan inputs to GPCH for developing an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful regulatory approval/market access for one or multiple treatment indications and/or multiple programs in Japan
５．Is responsible for Japan input to the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, Re-examination application dossier, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with CDP and TPP. Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, J-RMP, clinical benefit- risk assessment for license renewals) for the compound(s)
６．As the medical/scientific expert, contribute interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), Japan internal stakeholders (e.g., JPT, GDO/Trial management, Research, Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV), Health Economics & Outcomes Research, etc.), and internal decision boards lead clinical related health authority (HA) activities including development of briefing book and answers for questions from HA
７．Contribute to development of TA strategies (Rheumatology area)
８.　Provide on-boarding, coaching, and/or mentoring support; develop and foster Clinical Development culture
９. 　Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures
１０． 100% timely delivery of all training requirements including compliance

■Key Performance Indicators
The indicators below are applied for clinical related activities in Japan
Excellence in establishing clinical development and Re-examination strategy across various indications and programs with alignment across functions
Apply effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area
Robust evidence of quality medical/clinical review of trial data, development of CSRs
Support TA through high quality contributions to CDP and protocol reviews
Timely development of quality disease/program clinical standards, publications, and internal/external presentations
Timely delivery and submission of high-quality clinical program data in a cost-effective manner
External acceptance of clinical data and risk-benefit assessments by key decision makers including Health Authorities, pricing, and reimbursement bodies
Well contributed, effective, and engaged GCT(s) and GPT (as needed)
Clearly demonstrate Novartis Values and Behaviors

■休日：完全週休二日制

【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

オンコロジー領域における新薬開発プロジェクトの全体マネジメントをご担当いただきます

■休日：週休二日制

Job Description
· Contribute to regulatory events in Japan such as CTN, PMDA consultation and JNDA
· Contribute to Drug Metabolism and Pharmacokinetics (DMPK) and CP sections in the regulatory documents such as JCTD and JIB
· Check the future submission package of DMPK and CP areas
· Contribute to clinical studies AZKK implements, e.g., inputting CP sections in CSP and CSR, designing pharmacokinetic (PK) and pharmacodynamic (PD) assessments in clinical study
· Propose potential strategies based on DMPK/CP profiles at JPT
· Negotiate with PMDA on Japan development strategy and JNDA package

Accountability/Responsibility:
· Responsible for initial assessment of DMPK/CP profiles of new candidates
· Supports clinical options and strategies on Japan development program based on DMPK and CP profiles
· Supports PK and PD components in clinical studies AZKK implements
· Leads the CP/DMPK authoring in regulatory documents
· Responsible for DMPK/CP inquiries at regulatory events in Japan
· Responsible for Japan specific requirements on global DMPK/CP package, including CTD
· Supports the package inserts and interview form
· Responsible for giving clear instructions to Career Level C staff on his/her task
· Supports Career Level D staff on critical decisions on development strategy and regulatory interaction and accountable for the outputs
· Leads research collaborations on CP/DMPK with academia and biotech/Pharmaceutical companies in Japan

Clinical Pharmacology Scientist directly reports to the Clinical Pharmacology & Safety Science Director.

■休日：完全週休二日制, 年末年始

Japan EOR Senior Data Scientist is an expert role to provide scientific expertise in evidence generation so that key research questions are sufficiently addressed, and all research are planned and delivered in a way that represent cutting-edge science, methodologies, technologies, processes, and solutions in the Pharm industry. Senior Data Scientist reports to director of Data Science, EOR.

1. Lead/co-leading of observational/database research and data analytics
2. Assessment of study design/target population/data source/data handling/analytical method and give suitable inputs from an epidemiological point of view
3. Oversight of venders (timeline management, quality of outputs, resource, & budget)
4. Survey & assess the necessary information for database and recommend database that fits for research/analytical purpose

■休日：完全週休二日制, 年末年始

■Job Description

・ Execute Evidence Generation Strategy in the responsible products of Hematology team by closely collaborating with Medical members, external healthcare professionals/experts, Evidence Generation and observational research team, Global stakeholders, ensuring clinical studies are appropriately planned, executed, and results are published to support business strategies for unmet medical needs and clinical questions as the main Medical lead for input and trial execution related to products and diseases.
Promote the appropriate publication of scientific data and the provision of high-quality scientific and strategic evidence through close collaboration with internal and external stakeholders via AZSS (AZ sponsored study) and ESR (external sponsored study).
・ Collaborate with MAD (MA director)/MSLM (MSL manager)/MSLD (MSL director) to contribute to the execution of processes from preparation to completion for materials/resources for critical medical messages, KEE communications, MSL training plans, and related materials, and implement the utilization and reflection of MSL insights into the Evidence Generation Plan (EVP) with stakeholders.
・ Appropriately manage risks based on related SOPs and compliance in complex situations or new activities.
・ Formulate medical strategies with MAD, manage the execution of activity plans including budget and resource management in line with the strategy, and contribute to the development and maximization of team members' capabilities.
・ Lead and deliver results for cross-team/department tasks and projects (including supporting team members).
・ Partially support MAD's role as needed.

■休日：完全週休二日制, 年末年始

■医薬品安全性監視部門（PVG）におけるProject ManagementおよびLine　Management業務全般

《主な業務》
・安全性情報管理（医薬品の臨床試験・市販後）のプロジェクトマネジメント
⇒Projectの進捗と品質、収益等の管理業務、及び、プロジェクトにおける顧客対応業務。
また、他のManagerと連携し、Projectの業務計画と要員計画の立案、業務配分調整やProjectの状況の確認・評価、報告を担当いただきます。
・要員計画、業務配分、業務の指導など、担当するチーム（10名程度）のLine Management業務
・担当するチームのスキルレベルと生産性の向上、および、働きやすい環境作りをリード。
・担当するチームのメンバーと定期的なコミュニケーションを行い、パフォーマンス評価とキャリア開発。
・グローバルチーム、および、提携企業と協力して、顧客との良好で強い関係を維持。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始