Jobs list of Pharmaceutical

Account Manager

Sales incentive: Every quarter+ Annual(5 times per a year)

5 - 8 million yen Tokyo Pharmaceutical Sales / MR

Company overview: We provide medical and security services, specializing in healthcare, safety, and logistics. Our 24/7 support system spans over 90 countries, ensuring the health and safety of employees worldwide. We offer risk management, emergency support, and consulting services. Our assistance services are delivered by medical and security experts, supporting sustainable business operations by prioritizing employee safety. Our mission is to facilitate safe and sustainable business practices globally.
Responsibilities: Manage a portfolio of SME (small/medium) client accounts, either with direct ownership or part of an Account Management Team overseeing a pool of clients, through all stages of the client journey from onboarding, engagement & utilisation, account extension and specifically focused on timely renewal execution as per the defined process.
Consistently demonstrates an Intermediate level of the following competencies:Develop, manage, and progress a pipeline of renewal and extension opportunities to support successful timely closing and reporting.
Value and Targeted relationship selling methodology
Adaptability, creativity, innovative and uses initiative to drive success measures.
Strategic thinking and critical judgment.
Customer orientation (internal and/or external customers).
Technical knowledge of our services
Commercial acumen, including the ability to negotiate successfully to protect profitability and increase gross profit

Consistently demonstrates an Intermediate level of the following competencies:Time management, responsiveness, and priority setting
Verbal, presentational, and written communication skills
Self-driven to continue to develop as an Account Management professional

Consistently demonstrates a Proficient level of the following competencies:Teamwork, alongside individual ownership, and action orientated mindset

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Hematology Medical Affairs Senior Manager

充実したキャリア支援制度／生産性高く働ける環境

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: The MAS role family comprises a variety of medical scientific specialties, such as office Medical (oMAS) and field Medical scientist (fMAS).Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Lead and develop a team of fMAS to maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes with collaboration with office MAS. Main responsibilities:
People DevelopmentGuide and develop members in order to contribute to optimization of product values from the scientific point of views
Contribute to developing team members through appropriate assignments, coaching, appropriate appraisal and constructive feedback
Effectively manage through and lead the change in an evolving healthcare environment
Collaborate effectively and demonstrate leadership and teamwork with peers, internal stakeholders and external customers that inspires alignment and partnership on a shared vision or strategy

Demonstrate medical and scientific leadership and expertiseProvide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.

Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and disease area(s) in collaboration with office medicalIdentify unmet medical needs and healthcare disparities in the assigned asset(s) and disease area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the assigned disease area(s) and asset(s) to establish scientific peer level professional relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in the assigned area.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (incollaboration with the Health & Value team) and ensure timely publication of data.

Establish a highly reliable, long-term relationship with stakeholders.Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus

Align, contribute, and collaborate with relevant internal stakeholdersProvide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with Medical Affairs HQ colleagues and cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.

Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.

Ensure awareness of responsibility for reporting adverse eventsFor all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

As neededContribute to Business Development in the assigned area(s): In collaboration with Japan Medical Lead, Japan Medical Affairs Product Lead, Global MA members and other members from relevant functions, identify unmet medical needs and candidate therapies for potential medical interventions in the assigned disease area(s) in Japan through medical activities such as advisory boards and consultations with medical experts while keeping confidentiality.
Rapidly respond to critical supply issues from the medical perspective (e.g., rapid communications with academic societies and regulatory authorities)

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Lung Cancer Medical Affairs Associate

A highly productive work environment

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: MAIN REPONSIBILITIES:
Contribute to the development and implementation of a product strategy as a core member of the Product Team by conducting medical strategy and delivering medical and scientific advice both internally and externally to ensure that the short and long term business goals of assigned products are achieved and that the interests of the customer and company are safeguarded.
Ensure implementation of appropriate global and Japan medical strategies into actions by acting as an interface with regional and global asset and marketing colleagues
*Non-manager gain support from Sr. Manager to fulfil responsibilities
Execute Medical plan to meet unmet medical needs related to products in the assigned area
Create Medical Plan in the assets in collaboration with Therapeutic area Medical Team Lead.
Execute some part of Medical Plan in the assigned area such as medical advisory board meeting, publication, promotional documents review in collaboration with Therapeutic Area Medical Team Leads.
Provide information on customer’s feedback on product development and life cycle strategies to related divisions/department in the company.
Support promotional document review in collaboration with Therapeutic area Medical Team Lead
Support medical/scientific education to MRs in disease areas.
Medical & Scientific communication (Meet domestic/ global medical KOLs and provide/exchange scientific information)
Establish a good and highly reliable relationship through non-promotional activities such as scientific exchanges (e.g. discussion using latest research papers and follow-up of contents of academic conference presentations) with domestic top-level medical KOLs in the assigned area.
For creating Medical Plan, acquire extensive medical/pharmaceutical information and gather latest medical information in the assigned area.
In response to UMR (Unsolicited Medical Request: spontaneous request for medical information), provide accurate, high-quality and unbiased information to important customers, stakeholders and medical relevant colleagues.
Medical & Scientific communication (Meet domestic KOLs and provide/exchange scientific information)

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Dermatology Medical Manager

A highly productive work environment

10 - 17 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: JOB POSITION PURPOSE
The MA role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical.Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes.
MAIN RESPONSIBILITIES:
Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.
Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in dermatology.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (in collaboration with the Health & Value team) and ensure timely publication of data.
Demonstrate medical and scientific leadership and expertise
Provide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.
Contribute to achieving the department/team goals, and/or participate in cross-organizational projects as a core member and provide guidance to deliver the results.
Play an active role in supporting members in the team/organization with the line manager to move towards its goals
Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and therapeutic area(s) in collaboration with office medical
Identify unmet medical needs and healthcare disparities in the assigned asset(s) and therapeutic area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the therapeutic area(s) and asset(s) to establish collaborative scientific relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Establish a highly reliable, long-term relationship with stakeholders.
Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
Maintain and enhance the cross-BU alignment on metrics
Ensure to collect necessary information and analyze insights prior to the meetings in order to provide deep medical and scientific expertise to stakeholders and HCPs
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus
Align, contribute, and collaborate with relevant internal stakeholders
Provide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.
Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.
Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.
Ensure awareness of responsibility for reporting adverse events
For all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

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開発企画推進部（統計解析職/リーダークラス )

製薬企業・CROで統計解析担当者として、3年以上の業務経験が活かせます。

6.7 - 8.2 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is selling, importing and exporting pharmaceuticals and other products.
Responsibilities: 治験計画時：治験相談、症例数設計、プロトコル作成サポート、統計解析計画書作成
治験実施中：解析帳票/CDISCデータ作成（業務委託先のコントロール）
治験終了時：解析報告書作成、CSR/CTD作成サポート
承認申請時：CDISCデータ提出、照会事項対応、適合性書面調査対応

Martin Tsvetkov
Industrial & Life Science

品質保証（GQP対応）

グローバル対応含め多くの経験が積めます／平均年齢42.1歳／平均勤続年数14.7年

5 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client mainly engages in the research and development, manufacturing, sales, and import/export of pharmaceutical products.
Responsibilities: ■業務詳細：
医薬品および医療機器の品質保証業務
製造所管理（品質取決め、品質監査）
変更／逸脱／CAPA（是正措置・予防措置）の管理
品質情報（苦情を含む）の管理
品質不良／回収対応
文書管理（品質標準書、手順書の制改訂等）

■業務の特徴・魅力：
医薬品および医療機器の品質に関する様々な幅広い経験を積むことができます。特に、近年導入品や海外メーカーとのやり取りが多数発生しているため、グローバル対応も含む多くの経験が積めます。

品質管理／品質保証

GMP、GQPに関する知識をお持ちの方必見です

6 - 12.99 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: 同社は不妊治療等の研究開発を行うバイオベンチャーです。
Responsibilities: 【採用目的】細胞製品のQC及びQA業務をラボベースからリードできる人材の確保のための募集です。本ポジションでは、細胞製品の品質管理および品質保証業務を担当していただきます。【採用背景及び業務内容】同社はiPS 細胞を利用した生殖補助医療の開発に取り組む会社です。現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定され、そこで同社としてはGMPに準拠した製品供給体制を強化するため、当該パイプラインの開発に関連したQC/QA部門をリードできる人材を募集しています。応募者様のキャリア構築を踏まえいずれはプロジェクト全体のマネジメントや海外を含めたCMOやCDMOとの外部リソースに対するマネジメントなどQC/QAを超えた業務推進もお任せしたいと考えております。

【東京】クリニカルリサーチマネージャー（オンコロジー経験）

オンコロジー領域におけるCRM経験者必見です!

7 - 11 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
Responsibilities: 米国本社カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担っていただきます。
試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする
チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる
試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う
CRA（CRO含む）の相談窓口として、施設レベルの課題を解決する
試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

CMC（マネージャー）

英語（海外拠点とのコミュニケーション力）をお持ちの方必見です

8.4 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Our client is manufactures and sells pharmaceutical products.
Responsibilities: 開発プロジェクトや既存上市品の改善プロジェクト等に参加・サポート
新薬申請や一変申請／軽微変更届においてはCTD、承認申請書の作成において、品質試験関連の責任をもつ。
規制当局（PMDA 等）照会対応・申請戦略支援
上市品の逸脱・品質クレーム・変更管理サポート
新規CMOへの製造委託、製品の立ち上げに関して、分析技術の責任技術者としてCDMOサポート
試験委託や分析法移管に関して、責任技術者として試験委託や移管をリード
治験薬供給において、SOPの作成整備、治験薬品質管理責任者として委託先CDMOの品質試験関連の監督
不純物評価（含：遺伝毒性不純物、抽出溶出など）の実務統括
CMCマネジメント業務で発生する書類の管理、薬物管理

【東京】GCP監査担当者(責任者候補）

英語での文書作成及びレビュー経験を有する方必見です。

5 - 9 million yen Tokyo Pharmaceutical Clinical Development

Company overview: 同社は医薬品・医療機器開発事業を展開しています。
Responsibilities: CRO業務における品質管理の一環としての GxP監査業務（内部監査、ベンダー監査）及び関連する業務全般を実施いただきます。
GCP等の臨床試験の業務委託先の選定及び再確認を目的とした国内外のVendorアセスメント監査の実施
受託Projectに対する内部監査・受託監査の実施

ファーマコビジランス

症例評価プロセスのグローバルでの業務経験をお持ちの方必見です

8 - 14 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: 業務内容:
症例評価プロセス（治験及び市販後のAE情報収集、submission等）のグローバルハーモナイズ、プロセス自動化のプロジェクトメンバーあるいはワークストリームリード等

PV職

症例評価プロセスのグローバルでの業務経験、メンバーではなくPJを推進した経験がある方必見です。

11 - 15 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: 症例評価プロセスのグローバルハーモナイズ、プロセス自動化のプロジェクトリード等

プロダクトマネージャー

消費財・医療機器・医療材料などを扱う事業会社でのマーケティング経験5年以上をお持ちの方必見です

6 - 10 million yen Tokyo Pharmaceutical Marketing

Company overview: We are the Japanese subsidiary of a healthcare product manufacturing and distribution company founded in the United States. Recognized as a workplace-friendly company in the healthcare industry, we offer a wide range of product lines. We supply various products necessary for surgeries and examinations to hospitals, care facilities, and other healthcare settings. The disposable nature of our products contributes to infection prevention and operational efficiency. With a focus on disposable surgical products, we provide a diverse range of offerings to meet the needs of our customers.
Responsibilities: カテゴリー戦略：担当製品群の短期および中長期戦略の策定・実施。シニアマネジメントへの発表(英語、日本語)
製品開発：市場・競合・顧客ニーズの分析をもとに、生産サプライヤーと連携しながら、新製品開発や改良を実施
プロジェクトマネジメント：各製品プロジェクト計画・スケジュール管理（関連部署進捗を見ながら全体をマネジメント）
データ分析：販売実績や競合他社の動向を収集・分析し、戦略策定・製品開発に活かす
プロモーション計画：営業部門と連携し販売戦略に基づいたプロモーションを計画・実施、ツールの作成、製品トレーニングの計画・実施
生産サプライヤーマネジメント：海外サプライヤーの生産状況の管理

メディカルアドバイザー

メディカルアフェアーズにおける規制、臨床開発、医療コミュニケーションおよびコンプライアンスの要件に関する理解をお持ちの方

6 - 11.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.

Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies.
Responsibilities: MSL（メディカルサイエンスリエゾン）と共に外部専門家（EE）から洞察を得て、特定された医療ギャップに基づく医療活動を提案する。
臨床/前臨床研究、研究者主導研究、およびPMSを含むRWE（実世界データ）研究を通じて外部専門家と協力し、新しい科学的証拠を構築する。
マーケティングおよびマーケットアクセスと協力し、日本固有のニーズに対応するための統合資産計画（IAP）および詳細な年間コミュニケーション計画を作成し、グローバルIAPと整合させる。
TAにおける総合的な視点（リソース/予算の観点からの全プロジェクト/試験）に基づいて、NBIの開発/データ構築の意思決定をサポートする。
臨床開発フェーズ全体を通じて、BI企業および他部門と協力し、責任あるTAにおいて医療/科学的に堅牢なガイダンスを提供することで、NBI製品のプロファイルを強化する。
規制/臨床開発チームと協力し、各製品の日本での申請および登録を確実にサポートする（PMDAからの質問への回答準備など、承認までの臨床部分をサポート）。
各TAにおけるグローバル開発戦略と整合した日本の臨床開発計画をBIグローバルメディシンに認識させる責任を負う。
概念実証後および商業化後期におけるCDP（臨床データパッケージ）への医学的視点からの貢献。
製品のベネフィット/リスク評価への貢献。
規制および業界規則（プロモーションコード、公正競争規則、プライバシー、データ収集/保存など）および関連するSOPを理解し、遵守すること。

品質保証・統括業務（変更管理）

製薬業界または関連業界におけるGMP変更管理経験をお持ちの方必見です

11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: GMPに基づく変更管理プロセスの統括・運用管理
変更管理に関連する評価、承認、文書管理の監督
クロスファンクショナルチーム（品質保証、製造、エンジニアリング等）との調整・連携
規制当局対応及び監査対応サポート
変更管理システムの継続的改善及び教育・トレーニングの実施
グローバル標準及びローカル規制の遵守確保
海外拠点やグローバルチームとの定期的な打ち合わせ・調整
チームマネジメント

品質保証・統括業務（システム管理）

CSVに関する実務経験および知識（計画、実施、レビュー含む）をお持ちの方必見です

11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: システム導入プロジェクトにおけるQA視点での規制適合性監視（CSV管理含む）
CSV（Computerised System Validation）の計画立案、実行、レビュー、報告の監督
GMP/GxP環境におけるシステム運用監視およびグローバルシステムの管理・調整
規制要件（FDA 21 CFR Part 11、EU Annex 11等）に基づくシステム管理の指導
ITチームメンバーのマネジメント（育成、業務割り当て、評価）
品質保証部門および他部門との連携、グローバルチームとの調整
内部・外部監査対応のサポートおよび改善活動の推進
新しい規制動向や技術トレンドのキャッチアップと社内展開

バイオ医薬品の品質保証（査察対応・サプライヤー管理・プロセスエクセレンス・GMP統括/薬制）

医薬品を世界中の患者様にお届けする貢献と達成感を実感できる!

11.25 - 12.97 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: ■業務内容：GMPに沿った品質保証業務当局査察対応
自己点検
サプライヤー管理/サプライヤーAudit
パートナー会社とのコミュニケーション
CAPA管理
品質リスクマネジメント
高崎工場内の部署横断的な業務推進および関係部署の課題解決支援
Quality culture醸成活動
KPI/リスクレジスター管理
レギュラトリ―インテリジェンス
承認書維持管理、薬事支援業務
薬制業務
その他

■採用背景：早期退職制度実施後、組織の再構築を現在進めています。その中で、GMP及びOPEXを推進するリーダーが不足しており、GMP/GQPの経験が豊富な人材の採用が不可欠であり、中途採用で即戦力要員を補充したい。

■ポジションの魅力：グローバルスペシャリティファーマとして発展するKKCの中核となる製造所において、業務プロセスの継続的改善のための活動へ参画するとともに、バイオ医薬品の品質保証業務に関する幅広い経験を積むことができる。最新のPIC/S及びcGMP規制に基づいた品質保証システムを取りまとめる立場として、2027年に米国に竣工予定の製造所の立ち上げ業務に携わり、グローバル生産に関連する品質システムの構築を通じて、グローバルで通用するキャリアを形成できる。自社で開発・製造した医薬品を世界中の患者様にお届けする貢献と達成感を実感できる。

開発・運用担当者

GxP ITシステムの導入・運用実務経験をお持ちの方必見です

7 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: 下記業務の一部を担う。GxP部門横断ITシステムの企画、開発、導入、運用、廃棄における管理業務
CSV活動の主担当としての計画立案、リスクアセスメント、テスト計画・実施、逸脱管理、報告書作成
システム開発・運用を委託するITベンダーの管理・コントロール
ユーザー部門（品質保証、研究開発、製造等）との連携、業務要件の定義、課題解決の支援
ER/ES指針、データインテグリティ等の最新レギュレーションの動向調査と、社内システムへの適用推進
CSVに関するSOP（標準作業手順書）や各種手順書の作成、改訂、管理

医薬品の安全監視策、およびリスク最小化策の立案、実施

グローバル人材を積極的に採用しております。

8 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: 市販薬および治験薬の安全性管理業務（安全性監視計画の立案、安全性評価（シグナル評価）、RMP策定、添付文書改訂など安全確保措置の策定・実施など）
規制当局との対応業務（承認申請資料作成、定期報告作成、再審査申請資料作成、照会事項、適合性調査など）
グループ会社担当者（海外含む）と連携した活動（電話会議、メール連絡、海外出張など）

リスクマネジメントマネジャー

英語ビジネスレベルをお持ちの方必見です。

9 - 13 million yen Osaka Pharmaceutical Pharmacovigilance

Company overview: We are a major Japanese pharmaceutical company. We are a pharmaceutical company focused on eye health in particular, and are engaged in the research, development, manufacturing, and marketing of pharmaceuticals in the ophthalmologic field. We are particularly strong in the treatment of dry eye, cataract, and glaucoma, and have earned trust for our high technology and quality. We also have operations around the world and aim to contribute to eye health from a global perspective. In research and development, we are active in introducing new treatments and technologies to meet the various needs related to vision.
Responsibilities: 集積安全性情報に基づく、シグナルマネジメントの実行と適正使用推進のための企画、リスクマネジメント活動の立案と実行
製造販売後調査（PMS）の実施計画・解析計画と結果解析、総括報告書作成
RMP、安全性定期報告、再審査申請資料、ICH-PBRER、DSURの作成、海外現地セイフティーヴィジランス部門の要請に基づくデータ準備
KOLとの協調による、情報提供資材の発行、論文執筆や学会発表のコーディネート
外部／内部環境変化に対応したリスクマネジメント体制（システム）の維持更新と運営
個別症例評価と規制当局報告
各国規制要件の変更に伴うコンプライアンス体制の維持更新と運営

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