クライアントである製薬会社等と良好な関係を築き、さまざまな要望・期待に応え、満足していただけるサービスを提供することで、当社とクライアント双方にとってWin-Win となるようリードしていただくポジションです。

＜業務内容＞
1． 契約事項、薬事法、GCP 等の関連法規、SOP 等を遵守し、プロジェクト全体を管理する。
2． 受託業務内容を熟知し、業務全体の計画立案、各部門との調整、クライアントとの折衝を行う。
3． 臨床開発プロジェクトのプロジェクトマネジャーとして、部門横断的にプロジェクトチームをリードし、プロジェクトチ
ームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト、人員を管理する。 具体
的には、各プロジェクトが、Quality を担保しタイムライン通りにマイルストーンを達成できているか、各部門リーダ
ーから報告を受け、確認する。
4． クライアントの期待に応えるため、利益や品質の成果責任を果たせるようプロジェクトをリードする。
5． クライアントとの良好な関係を維持し、クライアントの満足度を向上させ、想定された利益を確保する。
6． 電話／ビデオ会議などを通して、カウンターパートとの情報交換やアラインメントを図るサポートを行う。

■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 夏季休暇, 日

COMPANY DESCRIPTION
Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。


JOB DESCRIPTION
信頼性保証オーディットチームは、監査を通じて参天製薬の各部門及び社外関連企業の業務の信頼性を保証するとともに、品質向上を導くことにより、参天製薬の企業価値向上を図る部門です。

本ポジションは、臨床試験活動および薬事申請活動の実施部門と協働しながら、独立性を確保して規制要件の適合性やマネジメントシステムが効果的に実施され維持されているかを確認・監査することにより、これら実施部門等業務の品質向上ならびに信頼性を保証することを基本使命とします。

具体的な職務内容は以下の通りです。
・GCP監査：医療機関監査、CRO監査、内部監査
・臨床研究監査：医療機関監査、CRO監査、内部監査
・製造販売承認申請資料監査
　　医療用医薬品、医療機器の申請資料（臨床パート）の監査
・コンピュータ化システムバリデーション
　　各種規制要件への適合確認

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

「日本主導のグローバル試験」において、プロジェクトの進捗、品質、予算等を総合的に管理するグローバルプロジェクトマネージャとして、日本経つグローバルプロジェクト、アジアプロジェクトをマネージメントしていただきます。
■職務詳細
・スポンサーとの調整
・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（日本を含むアジア、ヨーロッパ、アメリカ）の調整、進捗管理
・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
■メンバー構成：日本、ドイツ、韓国、台湾出身の方が在籍しております。
----------------------
The Project Manager manages the project team in the delivery of quality clinical trial management servicesto achieve the successful overall project completion. The PM will be expected to maintain an in-depthunderstanding of customer needs within the project group, to focus on achieving the project’s goals and tohave knowledge in the assigned therapeutic area. According to his/her knowledge and skills the PM maytake over any other tasks, duties, roles and job responsibilities at the discretion of the company andrelevant managers.The PM will provide a customer focused leadership role and may be assigned to manage multiple Phase Ithrough Phase IV clinical research trials across all functional areas. The role holder will assure theunderstanding and integration of all functions, roles and responsibilities within the clinical project team andwill effectively coordinate and manage cross functional teams that deliver clinical projects (ClinicalMonitoring, Data Management, Biostatistics, Medical writing, Pharmacovigilance, Regulatory) includingvendors, if applicable.The PM will monitor adherence to project contract and budget. In addition the PM is expected to assist withproposal generation within a multifunctional matrix setting. The PM is expected to assist in businessdevelopment activities to achieve high level of customer satisfaction and therefore ensuring repeat businessopportunities.

■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 夏季休暇, 日

業務内容

医学的・科学的見地に基づいたエビデンスの提示」と「KOLエンゲージメントの向上」により検査の価値を最大化し、販促戦略の構築と検査の普　 及に貢献をする事を 目指します。

　臨床研究に関する社内外の手続き（契約、倫理委員会等）、臨床研究モニタリング、DM、解析等を疾患担当と協働し臨床研究を円滑に開始し終　　了を目指す。

　派遣社員の方々と協働して仕事を進めていく中で、派遣社員に対する教育も担って頂きます。

■休日：完全週休二日制, 土, 日, 祝日

主に臨床試験のモニター業務をお任せします。
将来的には、モニターリーダーや開発テーマの責任者業務を担う可能性もございます。

＜具体的な業務＞
　・治験実施医療機関及び治験責任医師の選定
　・スタートアップミーティング
　・原資料の検証・データの検証
　・症例報告書の回収　など
　※月に数回国内出張あり

■休日：完全週休二日制, 祝日, 年末年始, 土, 夏季休暇, 日

【R&D】Associate Director Site Management & Monitoring (ADSMM), R&D Development Operations, Late Development Oncology Clinical Operation 1

■ 職務内容 / Job Description
Ensure study deliveries with appropriate quality in terms of site management and monitoring part.
Responsible for developing staff(Senior Clinical Research Associate and Clinical Research Associate) capabilities to achieve high level of performance and productivity with the potential to lead and deliver studies in Japan.

• Ensure study deliveries within agreed timelines, cost/resources and appropriate quality in terms of site management & monitoring perspectives
• Contribute to continuous improvement activities, including study processes and other procedures
• Ensure effective clinical and operational feasibility assessments of sites level to execute study deliveries
• Ensure quality of selection of investigators, sites and SMOs (if needed)
• Ensure subject recruitment strategy including risk management of site management and monitoring areas is performed for every clinical trial and contingency plans are in place
• Ensure necessary actions are taken as a result of audits and regulatory inspections
• Ensure contribution for regulatory inspections of site management & monitoring areas
• Ensure the sharing of experiences and best/bad practices in activities related to managing sites and delivery of clinical trials from site management and monitoring perspective
• As a member of the Development Operations Leadership Team to contribute to the effective execution and implementation of the Japan Development Operations and R&D strategy
• Demonstrate accountability on the quality of deliverables from job holder’s function, by confirming the process and communicating with their staffs regularly and proactively to identify the issues and potential risks that may jeopardize the quality of the deliverables, and take necessary actions (e.g. review the contents, training of the staffs and solving process issues etc.) in timely manner
• Develop staff within the group to lead and deliver reliable, cost-effective and high quality clinical trial data, optimising processes from operational site level study feasibilities through to study closures
• Conduct Performance and Talent Management (in line with HR plans), in order to attract, develop and retain the best personnel (talent base)
• Compliance with AZ Procedural Documents, international and local guidelines such as ICH/GCP and J-GCP
• Perform regular co-monitoring/accompanied site visits in order to ensure staff skills and knowledge
• Model behaviours that foster AstraZeneca’s preferred work environment, including adherence to AZ Code of Conduct
• Plan and manage workload of staffs, ensuring appropriate supply of resources, including use of contract staffs
• FTE capacity planning and monitor and control workload of staffs in the group in accordance with appropriate SHE and Compliance standard

■休日：完全週休二日制, 年末年始

■ 職務内容 / Job Description
Lead, Japan Clinical Operation Program (JPD, Lead) is accountable/responsible for leading the project planning for clinical operation in Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/submission and post registration product maintenance phases and will include local and global working.
The JPD, Lead is responsible for planning, oversight on related studies and mediator among Japan study team, project team and Global project/clinical team.
The JPD, Lead is one of the key members of Japan project team to represent Clinical Operation arena and to contribute JPT deliverables.

■Key Responsibilities
1. Project Level
・Contribute to planning and execution of Japan clinical operational part in Japan development plan with high quality insights from clinical operation arenas until ID approval, and responsible for leading a cross functional team of clinical experts in the planning and delivery of a defined clinical studies to quality, budget, time, managing resource and risk
・Lead strategies for the site selection/patient recruitment in feasibility assessment through external key stakeholders involvement to optimize the project deliverables
・Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans in agreed study planning systems
・PMDA interaction; Contribute to operational strategic interaction with PMDA
・JNDA; Responsible for health authority GCP inspection management
・Key Investigators Management/Engagement ; Act as a key point of contact for clinical operations related relationship with Key investigators and National Lead Investigators
・PUBLICATION; Contribute to author selection by providing required information and act a key point of contact for author/KEE

2. Study Level
・Lead program operational feasibility assessment including project management of the scope, schedule and budget
・Provide operational input into study feasibility, study specifications and vendor/partner contracts
・Handover study specification including the strategic context and the PMDA’s feedback of the clinical study discussed at Japan project team to study team
・Lead a large/complex work situation or oversight a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal stakeholders or external partners engagements
・Act as a point of contact with external partners for externally managed/outsourced studies as needed
・Oversight of the study delivery through regular communications with Global counterpart and, relevant persons in Japan study/site management functions to anticipate study requirements and mitigate risks

3. Collaboration with Marketing Company
For study support, act as a point of contact to MSL in Medical Affairs to collaborate on e.g., Programme feasibility/KEE Engagement, developing site candidates list, information exchange on sites
4. Others
Task outside projects; May be assigned responsibility for leadership and program/project management of non-drug project work, as the representative of Japan for the global initiatives, developing new processes in Japan R&D or the industry activities

■休日：完全週休二日制, 年末年始

【職務内容 / Job Description】
Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that:

The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete, and verifiable from source documents.
The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).

【Key Responsibilities】

• Acting as the main line of communication between the sponsor and the investigator.
• Communicate with Japan Study Leader and third party vendors as needed.
• Conduct site selection activities for verifying adequate qualifications.
• Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis by conducting the followings;

Manage the contracts of clinical trial with the responsible site and ensure the compliance with regulations and company-wide governance controls such as Ethical Interactions policy or company-legal standard.
Input appropriate information in order to create clinical trial related documents (ex. CSP, IND).
Ensure a steady implementation of supplying clinical site with study materials.
Provide investigators and site staff with education and training regarding study specific procedures including EDC system.
Manage the patient recruitment status and request acceleration of patient recruitment for Investigators and site staff.
Conduct source data verification and ensure data quality to collect appropriate clinical study data.
If necessary, support sites to ensure sites understand and resolve data queries in a timely manner.
Ensure that essential documents and source data are appropriately stored in a clinical site.
Produce monitoring activity reports appropriately and in a timely manner.
Confirm and ensure status of GCP/ICH guidelines, CSP and AZ policy compliance.
Report critical and/or serious issues relating to site management to the study team and line manager in a timely manner.

• Ensure input the latest site related information in IMPACT at appropriate timing.
• Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
• Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
• Cooperate with resolving the result of SAE reconciliation.
• Ensure inspection ready TMF regarding site related documents.
In addition to above, Senior CRA also is to
• Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
• Taking some tasks delegated by Study Leaders if agreed.
• Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training.
• Mentor CRAs on monitoring and internal procedures.

■休日：完全週休二日制, 年末年始

■ 職務内容 / Job Description

Programmer is a key player of conducting data analysis for Japan clinical development as well as for post-marketing surveillance to ensure Japan requirements. Therefore, Programmer surely plays the following roles. Programmer directly reports to the director of Biometrics, Data Science & Innovation.

1. Produce SAS programs and documents (e.g. specifications and mock shell) to deliver the tables, listings, figures (TLFs), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) based on agreement with user representative. Produce accordingly define.xml, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG) and Analysis Results Metadata (ARM).
2. Lead, contribute and/or support from the aspects of the Programming field toward submissions (including electronic data submission in accordance with CDISC standards), high level documents, responses to inquiries from the healthcare authority, PSUR, re-examination to meet the demands of regulatory authorities, publication activities and commercial works.
3. Control outsourcing partners/providers to ensure the quality and appropriateness of deliverables as internal programmers.
4. Ensure development of all SAS programming and report deliverables are performed in accordance with GCP principles, company policies and SOPs.
5. Provide programming expertise to delivery teams by reviewing documents, e.g. protocols, Statistical Analysis Plan (SAP), Case Report Forms (CRFs) and specifications.

■休日：完全週休二日制, 年末年始

【職務内容 / Job Description】
Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that:

The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete, and verifiable from source documents.
The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).

【Key Responsibilities】

• Acting as the main line of communication between the sponsor and the investigator.
• Communicate with Japan Study Leader and third party vendors as needed.
• Conduct site selection activities for verifying adequate qualifications.
• Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis by conducting the followings;

Manage the contracts of clinical trial with the responsible site and ensure the compliance with regulations and company-wide governance controls such as Ethical Interactions policy or company-legal standard.
Input appropriate information in order to create clinical trial related documents (ex. CSP, IND).
Ensure a steady implementation of supplying clinical site with study materials.
Provide investigators and site staff with education and training regarding study specific procedures including EDC system.
Manage the patient recruitment status and request acceleration of patient recruitment for Investigators and site staff.
Conduct source data verification and ensure data quality to collect appropriate clinical study data.
If necessary, support sites to ensure sites understand and resolve data queries in a timely manner.
Ensure that essential documents and source data are appropriately stored in a clinical site.
Produce monitoring activity reports appropriately and in a timely manner.
Confirm and ensure status of GCP/ICH guidelines, CSP and AZ policy compliance.
Report critical and/or serious issues relating to site management to the study team and line manager in a timely manner.

• Ensure input the latest site related information in IMPACT at appropriate timing.
• Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
• Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
• Cooperate with resolving the result of SAE reconciliation.
• Ensure inspection ready TMF regarding site related documents.
In addition to above, Senior CRA also is to
• Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
• Taking some tasks delegated by Study Leaders if agreed.
• Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training.
• Mentor CRAs on monitoring and internal procedures.

■休日：完全週休二日制, 年末年始

【職務の目的】
クリニカルサイエンティスト（CS）／シニアクリニカルサイエンティストは、臨床開発計画の策定、臨床試験デザインの策定、臨床試験結果の解釈、承認申請戦略の策定（臨床パートについて）、及び関連する文書作成の責任を有する。策定した臨床開発計画に従い、日本の臨床開発又はEvidence Generationにおける戦略的目標を達成することが期待される。CSは通常2つ以上のプロジェクトを担当する。プロジェクトの成功促進のため、日本のプロジェクトチーム、医薬品開発リーダー、メディカル及びその他の開発部門メンバー、及びグローバルの医薬品開発チームと連携する。

■主な業務内容
・日本の臨床開発計画を作成し、規制当局に対して説明する責任を有する。臨床開発計画に関わるグローバル及び日本の各Functionのリーダーとパートナーとして連携する。
・グローバルの臨床リーダーに対する日本のカウンターパートとしての役割を有する。グローバルの臨床リーダーと緊密に連携して、日本の開発要件をグローバルの臨床開発計画に反映する。
・グローバルの臨床リーダーと共に臨床試験を計画する。日本の社内外の専門家、ステークホルダー、及び患者から情報収集し、臨床試験計画に適切に反映する。
・臨床試験データの解析計画が日本の要件に沿っていることを担保し、試験データ（特に日本特有のデータ）の臨床的解釈に責任を有する。
・総括報告書の臨床的解釈に関するパートを作成する。
・当局関連文書（CTD、対面助言資料、治験届、照会事項への回答等）の臨床パートを作成する。
・Scientific meeting、学会発表、論文投稿のための文書（Abstract、ポスター、Manuscript等）を作成する。
・開発プロジェクトレベル又は臨床試験レベルにおいて、日本のプロジェクトチーム、早期開発チーム、メディカル及びコマーシャル部門に対し、臨床の観点（科学的側面）からのインプットを行う。
・外部の専門家（日本の規制当局、医師等）との科学的なコミュニケーションを主導する。

■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

■Job Purpose:
The Clinical Scientist (CS) is the single point accountability for the development of the Clinical Development Plan (CDP) and study design, interpretation of study results, as well as creation of filing strategy and documents of clinical part.

■Key Responsibilities:
Single clinical development voice at the study level (if program level: Lead CS) into Japan Project Team, Japan Early Development Team (J-EDT), Japan Medical Affairs, and Japan Commercial functions.
Lead scientific interactions with external experts (e.g. regulators, CROs, investigators), and work closely with CDL to input Japanese requirements into one development plan.
Create and deliver CDP. Develop filing documents (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority, etc).
Study Design: Develop study design, including integrated input from internal/external experts, thought leaders and patients in Japan. Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct.
Scientific oversight for the study: Ensure that study analysis plan for Japan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.
Evidence generation & outputs: In terms of Japan analyses, interpret study data to create the scientific content of Clinical Study Report (CSR) and prepare the abstracts, posters and presentations for scientific meetings, congresses, external journal publications. Prepare clinical content of regulatory documents and interaction with Japan regulatory authorities (e.g., CTN, PMDA consultation, CTD)

■休日：完全週休二日制, 年末年始

■職務の目的：
臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。

■業務内容：
海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。
・開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う
・臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理
業務全般及び組織運営にかかわる以下の活動を担う。

各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成）

■休日：完全週休二日制, 年末年始

【本職務の魅力】
・監査という業務の性質上、多岐に渡るファーマコヴィジランス業務全体を俯瞰する能力を獲得できる
・現地法人や社内他部署との連携に加え、監査や研究会参加を通じた他社との連携もあり、人脈を増やすことができる
・英語での議論が必要な場面もあり、ライティングのみならず会話の能力も獲得できる

【業務内容】
・ファーマコヴィジランス監査（欧州GVPガイドライン等に基づく）

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【本職務の魅力】
・GVP業務におけるQMS（Quality Management System）を理解し、その仕組みの構築、維持に関する業務を通じて、品質管理の本質が理解できると共に、業務全体を俯瞰してみる力及び関連部署との調整力を発揮することができ、また、組織への貢献を実感できる。
・グローバルQMS体制構築を通じて、海外規制の理解及びグローバルでのコミュニケーション力も発揮することができる。
・新たな業務の仕組みづくり及びeQMS（QMS管理システム）の運用管理等を通じて、論理的思考力を発揮することができる。

【主な業務内容】
・グローバルQMS（SOP管理、教育訓練、CAPA管理業務等）の体制構築・実施
・日本におけるQMS関連業務（SOP管理、教育訓練、CAPA管理業務等）の実施
・eQMS（QMS管理システム）の運用管理

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【本職務の魅力】
・Global Clinical QAの分野で活躍できる人財へと成長できます
・臨床開発業務に対する視座を高めることができます
・日本の本社社員として、海外で実施するGlobal臨床開発業務に貢献できます
・社内外の関連部門、海外子会社から規制当局まで、多様なStakeholderと協働できます
・業界の動向、規制変化など最新の情報を常に収集し、自身も成長できます

【主な業務内容】
ご本人の希望、経験及び能力などを考慮し、海外子会社への派遣なども視野に入れた最適なキャリアプランを提案します。
まずは、以下のA）もしくはB）の業務をご経験頂き、将来の小野薬品のGlobal Clinical QAを支えて頂ける人財へと成長頂きます。

A）Clinical Quality Management業務
・臨床開発におけるQuality Management Systemの構築、改善
・臨床開発関連法規制に係るSOP等の文書体系の管理
・重大なIssue発生時のCAPA対応等のIssue Management
・国内外の規制当局によるGCP査察に向けた準備、対応
・臨床開発に関連するトレーニングの計画、実施
・GCP等法規制に関する相談対応

B）Clinical Audit業務
・実施医療機関の監査
・社内GCPプロセスの監査
・外部委託先の監査

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【本職務の魅力】
・グローバルQA体制の構築を通じて、グローバルコミュニケーション力を発揮/成長することができる。
・新たな仕組みづくりを通じて、異文化間の調整力を養うことができ、QA業務の本質を理解することができる。

【主な業務内容】
・グローバル（日米欧韓台）にまたがるQAマネジメントの仕組みづくり。

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

・安全確保措置（添付文書改訂、RMPの策定等）の立案・実施、定期報告書類の作成・提出
・KOLとの意見交換・各種委員会の開催による医薬品適正使用の推進
・グローバル安全管理体制の構築、国内外規制当局等からの照会事項対応
・PMDA等による査察（再審査・適合性調査含む）や提携会社あるいは社内の監査に対応する
・海外現地法人のPV担当者や他部門と協働し、体制・プロセスの構築・維持・管理を推進する

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【主な業務内容】
・ファーマコヴィジランス関連のデータ解析及びデータマネジメント
・DXを通じたファーマコヴィジランス業務の効率化と新たな価値創出

その他、ご本人の適性や能力を考慮した上で、上記以外の業務もご経験頂くことも想定しています

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始