＜部署の業務内容＞
①医薬品工場の生産設備の保全業務（予防保全）
②インフラ設備、建物の維持管理
③設備、建物の更新/修繕計画立案、見積査定、施工管理
④生産設備の保全システム導入検討・管理
⑤省エネ・CO2削減対策活動の推進

ご経験に応じて、設備導入／電気主任技術者／保全のいずれかをお任せします。
＜担当業務＞
■設備導入
①医薬品生産設備の将来計画の策定や建物・設備の更新および導入計画を実行：60％
②生産設備の予防保全活動による生産機会損失低減活動の実行：30％
③保全システム・設備状態監視システム導入の検討・管理業務：10％

■電気主任技術者
①医薬品生産設備の安定稼働のため特高変電設備およびサブ変電設備、その他インフラ設備の維持管理業務を実行：50％
②インフラ設備、建物の中長期更新計画を策定し工場の将来計画を実行：30％
③エネルギー管理およびCO2削減対策のため、ユーティリティーの予実管理：20％

■保全
①医薬品生産設備の予防保全のため、設備メーカーと調整を行い、メンテナンス計画を策定し実行：60％
②点検後の要改善事項や、保守終了部品の更新計画を実行
③生産現場の設備トラブルを迅速に対応するスキルを身に付け、生産機会損失低減に取り組む
④生産設備には、FA機器が多いためPLC、ロボット、サーボ等の知識が求められます（スキルアップのため外部講習は積極的に参加できます）
　保全業務：60％、設備更新/導入業務：30％、保全システム導入検討・管理：10％


＜本求人の魅力＞
工務課では、医薬品生産設備の製剤・包装設備、空調設備・製薬用水設備といったユーティリティー設備の保全業務や、新設・更新計画にも携わることができ、エンジニアリング業務も経験することができます。特高変電所、カーポートタイプ太陽光発電設備の維持管理業務から、省エネ・CO2削減のエネルギー管理業務が経験でき、工場運営のサポートを幅広く実践し活躍できることが魅力です。

■休日：週休二日制, 土, 日, 祝日, 年末年始

＜部署全体の業務＞
医薬品等の製剤に関する以下の業務。　
①自社製品及び新製品の製造技術開発　
②品質改良及び製造工程改良　
③製造技術移転　
④バリデーションの実施　
⑤実験装置の点検、校正　
⑥校正標準機器の管理　
⑦設備改良及び導入検討　
⑧査察、監査対応

＜具体的業務＞
・既存製品/新製品等の品質改良及び製造工程改良、バリデーションの実施、 技術移転、実験装置の点検/校正 、校正標準機器の管理、設備改良及び導入検討など

■休日：週休二日制, 土, 日, 祝日, 年末年始

①製剤または包装作業及び工程管理
・実務作業、作業手順・記録類の書類作成、確認　　
・担当工程における作業及び労務管理

②設備メンテナンス
・保守計画の立案、実施及び進捗管理

③その他、係長、工程責任者の補助業務
・生産計画、購買、逸脱対応、改善等に関する業務

■休日：週休二日制, 土, 日, 祝日, 年末年始

①法令・要求事項に対応した工場内の品質システムの構築及び維持管理
②品質文書（GMP管理文書、品質管理など）の作成／指導／管理
③品質に関する教育訓練の立案及び実施
④製品の製造記録類の照査及び保管
⑤GMP自己点検の計画及び実施
⑥行政当局への対応
⑦製品の品質苦情処理
⑧製品の資材・改訂に関わる品質記録の受付・伝達
⑨品質システムの関連事項（各国の法規制）の調査、情報収集、伝達
⑩工場内の変更管理
⑪製造時の逸脱管理
【業務詳細】
・製造記録・試験記録の照査30％
・品質システム（逸脱・変更・CAPA等）の担当者30％
・品質文書の作成および審査10％
・監査関連業務（供給者、自己点検、外部からの査察）10％
・その他、品質保証に係る業務20％

■休日：週休二日制, 土, 日, 祝日, 年末年始

①医薬品（原薬）の製造
②原料、資材の受入
③製造設備の維持管理（点検・校正、及び更新対応）
④品質文書の維持管理（手順書作成、記録類の保管）
⑤製造環境の維持管理（衛生状態の復旧を含む）
⑥安全衛生　等
※シフト制での勤務となっており、夜勤はありません。

【詳細】
・製造作業への従事を主とし、その中で得られた知見から改善活動や修繕作業を進めるとともに手順書へ反映させる。
・製造付帯業務として、衛生面を含めた製造環境、製造(支援)設備の維持、さらには設備トラブル発生を予防する。
・将来の管理職候補として、課内の業務全般に積極的に関与して頂き、品質向上と業務効率化を推進させる。

■休日：週休二日制, 土, 日, 祝日, 年末年始

①原料・資材の受入試験
②工程試験、製品試験
③微生物モニタリングの傾向分析
④安定性試験
⑤分析機器の維持管理
⑥試薬・試液の調製と維持管理
⑦参考品の保管
⑧他部門からの依頼分析
⑨業務に関する手順書及び記録の作成
⑩分析法に関する検証や実験　等

【担当予定業務】
・試験検査業務
・手順の改訂　
・分析機器の維持管理

■休日：週休二日制, 土, 日, 祝日, 年末年始

医薬品等の製剤に関する以下の業務。　
①自社製品及び新製品の製造技術開発　
②品質改良及び製造工程改良　
③製造技術移転　
④バリデーションの実施　
⑤実験装置の点検、校正　
⑥校正標準機器の管理　
⑦設備改良及び導入検討　
⑧査察、監査対応

■休日：週休二日制, 土, 日, 祝日, 年末年始

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

The Position manages Pharmacovigilance activities in Japan, ensuring compliance with global and local regulations like GCP, GVP, and GPSP. It supports and may substitute for the Safety Contact Person. Responsibilities include overseeing safety report evaluations, managing Pharmacovigilance Agreements, providing safety information, and maintaining training and audit readiness. The role also involves preparing safety reports, developing Risk Management Plans, and handling GPSP-related tasks. Collaboration with regulatory authorities and internal teams is essential.

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

■POSITION SUMMARY
This position leads the pharmacovigilance (PV) function in Japan, ensuring the effective delivery of PV consulting services to pharmaceutical companies. The role requires a balance of hands-on project delivery, team leadership, and business development responsibilities. The individual will build and develop a local PV team while collaborating closely with global colleagues to align with the overall practice strategy.
The role covers a broad scope of client engagements, from early development consulting to post-marketing PV strategies. It involves frequent client interaction, internal coordination, and participation in external networking and industry discussions.

■RESPONSIBILITIES
Delivery
● Accountable for successful delivery of all PV consulting projects in Japan.
● Serve as a project leader or subject matter expert (SME) in PV where necessary.
● Provide guidance and problem-solving support to Japan-based consultants facing project challenges.
● Collaborate with the global team on staffing for Japan-based PV projects.

Business Development
● Identify and pursue new business opportunities based on client needs and market trends.
● Foster strong client relationships through regular communication and visits.
● Support proposal development and represent the Japan PV function at client meetings and industry events.

Team Development
● Collaborate with global and local leadership to define hiring needs and recruit local talent, including independent consultants.
● Lead onboarding, coaching, and performance management of PV team members in Japan.
● Serve as the go-to person and leader for the Japan PV team, ensuring team cohesion and alignment with company goals.

Thought Leadership
● Contribute to the strategic direction of the global PV practice, identifying opportunities for service expansion and innovation.
● Represent the company at industry forums, conferences, and networking events, sharing insights and thought leadership.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

■POSITION SUMMARY
The Deputy Director of Clinical Science is responsible for overseeing the planning and management of clinical development projects in Japan. The role requires collaboration with internal teams and external stakeholders to ensure the successful design and implementation of clinical strategies aligning with global and local regulatory requirements, while adapting to evolving circumstances, managing uncertainty, and responding effectively to competitive environments. The role will serve as a key liaison between clinical leaders of the client company and the Japanese team, contributing to regulatory submissions and clinical study design for the Japanese market.


■RESPONSIBILITIES
● Develop and manage clinical development strategies for Japan, ensuring alignment with global plans.
● Lead the design and planning of clinical studies, incorporating insights from local experts,stakeholders, and patient data.
● Prepare clinical documentation, including clinical sections of regulatory submissions (e.g., CTD,face-to-face advice materials).
● Collaborate with Japan project teams, providing clinical input on the client’s project.
● Facilitate communication with external experts, such as Japanese regulatory authorities and key opinion leaders (KOLs), to ensure productive scientific engagement.


■職務概要
本ポジションは、日本における臨床開発プロジェクトの計画及び管理を監督する責任を負う。本ポジションには、グローバル及びローカルの規制要件に適合した臨床開発戦略の適切な設計と実施のために、社内チーム及び社外ステークホルダーとの協働が必要とされ、変化し続ける環境に適応し、不確実性を適切に管理し、競争環境に効果的に対応することが求められる。本ポジションは、クライアント側の臨床リーダーと社内チームの間の中心的なリエゾンとし、日本市場向けの臨床試験のデザイン及び薬事申請へ貢献する。


■主な業務内容
● グローバル開発計画との整合性を確保しつつ、日本における臨床開発戦略を策定及び管理する。
● 国内の専門家、ステークホルダー及び患者データから得られた知見を取り入れ、臨床試験の設計と実施を主導する。
● 規制当局への申請資料（CTD、対面助言資料など）の臨床パートを含む臨床文書を作成する。
● 日本のプロジェクトチームと連携し、クライアントのプロジェクトに対して臨床的なインプットを提供する。
● 有益的な科学的交流のために、日本の規制当局やKOL などの外部専門家とのコミュニケーションを促進する。

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

・製品戦略および中長期的なマーケティングプランの策定
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

【Job Purpose & Key Responsibilities】

・Act as a strategic advisor and partner with the business to develop compliant solutions for Commercial
Practice and/or Medical Activity
・Ensure governance framework is defined and there is clearly defined links and escalation to and from
each governance board within the country
・Design and ensure implementation of the Internal Control Framework that enables risk oversight and
effective controls.
・Promote a Values-based culture through encouragement of, among other things, Speak Up
・Influence the culture and practices of employees at a division or function level
・Partner with key leaders and managers in the business and influence their strategies, risk management
processes and strategic decision-making
・Help the business evaluate and agree on its appetite for risk and explore options for proactive and
pragmatic mitigation
・Be responsible for ensuring the plans and actions are in place to achieve the objectives and follow up
with risk owners / functional heads etc to ensure delivery
・Facilitates the completing, reviewing and assessing the area and BUs’ Risk Management Plans
・Implements training and communication as necessary for the GSK Code of Conduct; other relevant
policies, procedures, and standards; and the Integrity Helpline

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

■Job Purpose:
The Medical Writing is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has ability to plan and prioritize without supervision.

■Key Accountabilities/Responsibilities:
・Proven track record in writing a range of clinical documents, including regulatory documents, including but not limited to clinical study reports (CSR), protocol, common technical document (CTD) and material to support health authority interactions for China and Japan submissions.
・Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
・Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions in China and/or Japan.
・May lead one or more assets and serve as a medical writing point of contact for this/these assets.
・May lead and coordinate a submission or a project as MW submission/project lead to ensure timely delivery of quality documents and contribute to MW strategic documents. If applicable provide oversight to 3rd party MW activities and contribute to contracting process.
・Drive collaboration between China and Japan MWs. Promote leadership behaviors that support GSK values.
・Demonstrated effectiveness in management of projects of increasing scope and complexity.
・High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
・Assess trends and patterns in text and statistical data and effectively organizes content and messages in clinical reports and summary documents.
・Review reporting and analysis plans and provide critical input on the content and display of tables.
・Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to use new technology, to work collaboratively between China and Japan teams, to support documents in different therapeutic areas, etc).
・Support Medical Writing-led process improvement initiatives (e.g. simultaneous submission with US/EU and hyper-acceleration), change management, and the implementation of business guidance/working standards.

■休日：完全週休二日制, 年末年始

・各部門のパートナーとして新規案件のコンプライアンスチェック、事前相談など
・コンプライアンス研修の企画、運営
・新たなルールやコンプライアンス制度の組織への落とし込み
・各関連部署との連携によるコンプライアンスの推進

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

HRオペレーションの一員として、チームメンバー（派遣社員含む）と共に以下の業務を行う：

1. 給与関連オペレーション
・勤怠管理、申請ワークフローの管理運営
・給与、賞与、退職金計算と支払
・年末調整と後処理
・仕訳、給与関連伝票作成、決算関連データ作成
・定期的に実施される内部/外部監査対応

2. Workday及び各種社内システムを用いたEmployee life cycle管理
・入退社・異動、休業者管理
・契約社員、定年後再雇用社員の契約管理、契約書作成・締結
・グローバルチームと連携したWorkday、ServiceNow及び各種社内システムの管理運営

3. 社員データの管理・活用
・ビジネスに貢献するHR分析データの維持・管理

4. HRサービスセンター
・ServiceNowを活用したセルフサービスの促進
・社員問い合わせ対応

5. 上記1-4に関連するグローバル・リージョンとの連携、ローカルベンダーマネジメント

6. ローカル及びグローバルプロジェクトへの参画

■休日：完全週休二日制, 年末年始

Job Purpose:
￣￣￣￣￣￣
At GSK, we are uniting science, technology, and talent to get ahead of disease together. The Associate Director, RWE-HO drives the development and execution of health economics, outcomes research, and real-world evidence strategies to demonstrate the value of GSK's medicines and vaccines in alignment with access, reimbursement, and lifecycle management goals. This role works in a matrix environment with local and global teams to ensure impactful evidence generation to inform payer, clinical decision-making, leading to successful patient access.

Key Responsibilities
￣￣￣￣￣￣￣￣￣
The role will report directly into the TA Head of RWE-HO for an/ multiple asset(s) and will have expertise in real-world evidence and other non-interventional study methods. The role will be a key member of asset team and other relevant matrix leadership teams. The Associate Director, RWE-HO will be accountable for engaging closely with medical and matrix stakeholders and partner effectively in data generation plan (DGP) planning, design, execution, translation and dissemination at the study level for the asset.

・Plan, design and execute multiple studies for a given asset and manage timelines, deliverables, and budget
・Assure quality of deliverables, including review and sign off project specifications, protocols, data analysis plans, final study reports, abstracts, posters and manuscripts, adherence to SOPs.
・Identify resources, references and analyses to inform scientific design and advise internal experts (clinical, commercial/market access) and external experts as needed in support of the asset team
・Translate identified needs for evidence into study concepts in alignment with strategic objectives and vision for the asset, e.g. development of study protocols and proposing innovative and cost-effective ways of developing and executing studies
・Develop and maintain a good working knowledge of real-world data resources, existing partnerships and public initiatives and become the point person for select sources to advise on their suitability to address given research questions.
・Develop a deep understanding of customers’ needs, including HTA requirements, as well as the acceptance of RWE or economic evidence and impact for the decision making of different stakeholders (reimbursement, medical societies, physicians)
・Collaborate with internal teams and participate in best practice sharing sessions across global RWE-HO organization
・Build strong working relationships with stakeholder groups across medical, market access, R&D and commercial to ensure strategic alignment and optimal cross-functional collaboration and communication
・Ensure key stakeholders including TA aligned business leaders are regularly updated on plans through periodic reporting
・Monitor the external environment (e.g., payer landscape, HEOR methodology trends, data infrastructure) to inform evidence planning
・Develop excellent working relations with external thought leaders to ensure appropriate methods and research agendas are applied, in accordance with GSK policies.

■休日：完全週休二日制, 年末年始

■Job Purpose
Responsible for all aspects of Automation and controls, obsolescence management and Cyber & OT security. Act as SME and engineering authority for Automation.

Following will be key areas of scope,

・Lead Cybersecurity strategies for OT Systems
・Lead automation aspects.
・Manage OT Equipments and lifecycle
・Maintain Calibration Standards for all equipment.

■Key Responsibilities
－Manage Automation solution & OT lifecycle:

・Design, implement, and maintain industrial automation systems (PLC/SCADA, IoT, robotics).
・Monitor and secure OT (Operational Technology) environment.
・Embed the OT cybersecurity standards and principles at Site.
・Develop and enforce cybersecurity policies for automated systems.
・Perform risk assessments and implement vulnerability management in control systems.
・Integrate network and endpoint security into smart manufacturing/production lines.
・Collaborate with IT and engineering teams to ensure secure-by-design automation.
・Investigate and respond to security incidents in automated environments.
・Development and delivery of training materials for OT systems and cybersecurity standards
・Develop and install new systems, where it is possible to introduce new technologies, throughout the site to aid process performance, safety, and reliability.
・Ensure secure and stable operations for the OT Systems. Lead OT security alerts at site and ensure timely completion.
・Identify and resolve automation issues by implementing effective and reliable solutions.

－Maintain standards :
・Ensure that Automation & Control systems are reliable, robust, validated and conform to regulatory, GMP and Cyber Security standards.
・Also ensure Calibration standards are followed and applied across Site for instruments.

■休日：完全週休二日制, 年末年始

＜Principal Clinical Pharmacology Scientist＞
【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.

【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.

＜Clinical Pharmacology Scientist＞
As Clinical Development Professional you will be responsible for the execution and delivery of assigned studies across therapy areas to time, budget and quality as defined in the study protocol and local regulations. You will also serve as the local point of contact between the central study team and the in-country operational staff.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
・Accountable for the execution and delivery of assigned studies to timelines, budget and quality expectations
・Point of conduct for trial assessment or inspection
・Drive decisions related to the conduct of a clinical study locally including escalating issues
・Collaborate with global and local matrix teams on the local model informed consent form, local investigator meeting planning and oversight of training delivery, study performance and risk management, budget development and oversight of payments to sites and vendors
・Responsible for matrix leadership and project management
・Serve as the operational point-of-contact between the central study team and in-country operational staff
・Identify and share best practices while working to standardize across the local operating company and regions that may be involved in internal and external process improvement teams.

■休日：完全週休二日制, 年末年始