Jobs list of Pharmaceutical

治験薬（製剤）品質保証

医薬品・医療機器等の企業でのGMP/GQP品質保証業務経験をお持ちの方必見です

9 - 11 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
Responsibilities: 国内外レギュレーションに準拠した治験薬（製剤）の品質保証業務をお任せしていきます。【具体的に】委託先・供給業者監査
（国内のみに限らず海外対応も含む．海外委託先との会議・実地監査）・品質契約（国内のみに限らず海外対応含む．英文品質契約書の締結）の締結変更管理/異常・逸脱対応/苦情対応/回収/自己点検/マネジメントレビュー対応
治験薬製造記録及び分析記録の照査/出荷判定
新薬承認申請資料（CTD及び生データ）の照査

Martin Tsvetkov
Industrial & Life Science

品質管理

医薬品・食品・化粧品会社での製造または品質管理経験をお持ちの方必見です。

5.5 - 7.7 million yen Tochigi Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client is a comprehensive manufacturer of clinical diagnostic reagents.
Responsibilities: 体外診断用医薬品（IVD）・その他臨床検査試薬・原材料・資包材の品質管理
新製品・改良品の研究部門あるいは製造部門からの受入れ
製品及び製造工程の見直し・改善
品質保証対応業務（苦情調査、測定依頼対応）

事業開発マネージャー

海外パートナーとの交渉、契約締結のご経験者必見です!

10 - 13 million yen Kanagawa Pharmaceutical Research & Development

Company overview: Our client provides integrated drug discovery research support services.
Responsibilities: 当社のビジネス拡大における事業開発の実務担当として、事業開発活動の推進を行っていただきます。
パートナーとの交渉および契約締結のリード
新規案件開拓、探索、パートナーとの信頼関係の構築
アライアンスマネジメント等
※日本国内、アメリカ、ヨーロッパ等へ出張する機会があります。

生産管理

メーカーでの製造・品質管理・生産管理等の経歴が活かせます。

5.5 - 7.7 million yen Tochigi Pharmaceutical Research & Development

Company overview: Our client is a comprehensive manufacturer of clinical diagnostic reagents.
Responsibilities: 当社製造品（臨床検査薬等）の需要予測
生産計画の立案と進捗管理
関連部門との生産調整業務

[Tokyo] Experienced CRA (including Sr./Pri.)

Global Pipeline with Work Life Balance

4 - 10 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: Work to confirm (monitor) whether clinical trials are conducted in accordance with relevant laws and regulations (GCP) and implementation plans (protocols) at appropriate medical institutions under consignment from clients, and whether the human rights and safety of subjects are protected is. Selection of medical institutions and doctors in charge of conducting clinical trials
Confirmation of clinical trial schedule and contract details, and implementation of briefing sessions for medical institution staff
Clinical trial progress management: Progress management of the number of cases, collection / inspection of case report reports, collation of case report reports with materials
Delivery of investigational drug, confirmation of supply management status, collection
Preparation of monitoring report
Clinical trial completion procedure, confirmation work

[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation

Rewarding Career, Global Development

9 - 14 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.
Responsibilities: MANAGE / MONITOR THE PROGRESS OF YOUR TRIAL ON-SITE OR OFF-SITE, AND CONDUCT, RECORD, AND REPORT YOUR TRIAL IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL, SOPS, ICH / J-GCP, AND OTHER APPLICABLE LAWS AND REGULATIONS. GUARANTEE THAT YOU ARE
RESPONSIBLE FOR CONTRACT NEGOTIATIONS AND CONCLUSIONS WITH MEDICAL INSTITUTIONS
WORK CLOSELY WITH OTHER CLINICAL TEAM MEMBERS TO TIMELY RESOLVE ANY CLINICAL TRIAL ISSUES THAT ARISE
INEXPERIENCED GIVE APPROPRIATE GUIDANCE TO MEMBERS AND CONTRIBUTE TO THEIR GROWTH

Site Activation Specialist/In-House CRA

グローバル臨床試験における契約交渉および費用交渉のご経験が活かせます！

5 - 7 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.
Responsibilities: 【1】Site Activation業務
Investigator recruitmentおよびfeasibility
治験施設との臨床試験契約の交渉と継続的な管理。
臨床試験実施における治験施設のタイムリーな立ち上げをサポートするための契約実行スケジュールの管理
部門のガイドラインに基づき、社内外の関係者に法律や予算の問題を伝え、説明し、国特有の法律や規制が守られていることを確認
クライアントの要求した契約変更をレビューし、評価し、部門のガイドラインに基づいて、適切に逸脱を報告
契約書の完全性と正確性を評価し、部門のガイドラインに準拠しているかどうかを確認し、契約書を修正し、契約書変更のファイリング

【2】In-House CRA業務
被験者のscreening/enrollmentサポート
CRFのチェックおよび回収サポート
Clinical supply/service vendorsおよび社内関係チームとの連携
CTMS等の使用による費用請求・支払の対応
必須文書の収集・レビュー・管理およびclose-out

Inexperienced CRA

Inexperienced

4.5 - 6.5 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We are a global leader in biopharmaceutical development based in the United States.
Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.
Responsibilities: 治験を実施する医療機関や医師の選定
治験の依頼・契約
治験薬の搬入及び回収
モニタリング
GCP、治験実施計画書、SOP に則って治験が進んでいるかを確認
直接閲覧（SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
IRB（治験審査委員会）への文書提出及び手続き
医療機関における保管必須文書が適切に保管されているか確認
モニタリング報告書作成
治験の終了手続き等

Clinical Research Associate/臨床開発モニター(東京・大阪・神戸・在宅可)

Work on global projects at major CRO

5 - 10 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We are a global leader in biopharmaceutical development based in the United States.
Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.
Responsibilities: 具体的には以下のような業務を遂行します。
治験を実施する医療機関や医師の選定
治験の依頼・契約
治験薬の搬入及び回収
モニタリング・GCP(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認
直接閲覧（SDV: Source Data Verification)を実施し、症例報告書（CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収
IRB (Institutional Review Board)への文書提出及び手続き
医療機関における保管必須文書が適切に保管されているか確認
モニタリング報告書作成
治験の終了手続きなど

Specifically, we will carry out the following tasks:
Selection of medical institutions and doctors to conduct clinical trials
Making requests and handling contracts
Delivery and collection of investigational drugs
Monitoring - Confirming whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
Performing direct viewing (SDV: Source Data Verification), checking whether the case report form (CRF) matches medical records
Document submission and procedures to IRB (Institutional Review Board)
Confirming whether documents required to be kept at medical institutions are stored appropriately.
Monitoring report creation
Clinical trial termination procedures

薬事マネージャー

治験届の作成・提出に関する経験が活かせます。

10 - 12 million yen Osaka Pharmaceutical Medical Affairs

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: 治験届書及び添付資料の作成、維持・管理に関連する業務
規制当局（PMDA、MHLW等）との各種相談業務
承認申請関連業務（クライアント様への申請業務サポート）
薬事情報の収集、維持・管理に関する業務
部下の人事管理
その他（各種会議・研修等への参加）

メディカルアドバイザー

海外担当者とコミュニケーション可能なビジネスレベルの英語能力をお持ちの方必見です

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: グローバルの開発戦略や顧客からのインサイト、アンメットニーズに沿ったメディカル戦略・戦術の作成と実行を内外のステークホルダーとともに計画し実行する
BIのプロダクトを支えるための、日本の外部専門家との強いネットワークの構築
アドバイザリーボードの企画立案及び実施
臨床・非臨床の研究や医師主導臨床試験、RWD研究を通して外部専門家と協働し、価値あるデータを創出してデータギャップやアンメットニーズを埋める
マーケット部門との協働での、日本のニーズに合わせたGlobal Integrated Asset Plan（IAP）に沿ったIntegrated Customer Plan（ICP）の作成
各プロジェクトの質を担保しながら，タイムライン及び予算を考慮し進行する適切なマネジメント
メディカルインフォメーションの準備及び提供のサポート
PMSに対するメディカルアドバイス，サポート
法規制や業界ルール（プロモーションコード、公正競争規約、個人情報、データ収集/保管など）、関連SOP を理解し、遵守する。

MSL（フィールドメディカルスタッフ)

オフィスメディカルあるいはMSL経験者をお持ちの方必見です

6 - 10 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: A joint venture between two global healthcare companies to provide sustainable solution to pharmaceutical clients as a CSO.
Responsibilities: 担当領域のSTL(Scientific Thought Leader)との情報交換を通じて、最適な治療を普及させる役割を担う
メディカルストラテジーの策定
疾患領域の最新情報の提供
領域のSTLからインサイト収集
Medical Unmet Needsの同定
Real World Evidenceの創出や臨床研究の企画及び実施
アドバイザリーボードミーティングや講演会などの企画・実施
最新医学情報の収集と社内関連部署への提供
グローバル関連部署との折衝やコミュニケーションなど

開発／リーダー候補

医療機器の研究開発業務のご経験をお持ちの方必見です

7 - 10 million yen Chiba Pharmaceutical Research & Development

Company overview: Our client imports and sells medical equipment.
Responsibilities: 人工血管やステント関連品の開発業務全般をご担当いただきます。開発業務は製品の一部分の設計ではなく、新規製品の構想から設計、試作、量産移管までを一貫して担当していただきます。そのため業務の範囲としては、営業担当者に同行してドクターへのヒアリングから製品の設計業務、試作品の評価・検証など幅広く対応していただきます。また上市品の改良や、海外輸出に向けた再設計を行う業務もあります。

Takahisa Hitotsumatsu
Industrial & Life Science

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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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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【東京／8月以降入社】MSL（血液領域）～豊富なキャリアパス／研修・教育環境充実～

血液領域における経験ある方歓迎

6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: 業務内容：
MSLは、担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズを収集し、育薬に貢献することが主な役割です。
具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
【具体的役割】
KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集
主催、共催の講演会企画の立案、実行ならびに他部門の支援
医療従事者からの非臨床、臨床研究等の相談対応
Data generation plan の策定と戦略達成に必要なデータギャップの特定
パブリケーションプランの作成

【東京】MSL（未経験）

豊富なキャリアパス／研修・教育環境充実

6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: 国内トップクラスの規模とプロジェクト受託実績を誇る同社の一員となり、MSL（メデカル・サイエンス・リエゾン）としてクライアントビジネスおよび患者さんにとっての最適な治療法の確立に貢献していただきます。
MSLは、担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズ（注：未だ満たされていない医療ニーズ、有効な治療方法がない疾患に対する医療ニーズ）を収集し、育薬に貢献することが主な役割です。

具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。

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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プロジェクトマネージャー（PM）日本発のグローバルCRO

製薬業界もしくはCRO業界にて少なくとも8年以上の臨床開発経験が活かせます。

9.4 - 14.5 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We specialize in supporting new drug development. Our fundamental philosophy is to consistently provide professional quality in all aspects of pharmaceutical development and to pursue the happiness of our stakeholders, including pharmaceutical companies, medical institutions, patients, shareholders, and employees. Founded by nine members who previously worked on new drug development at a major domestic pharmaceutical company, we leverage our extensive experience in developing drugs such as immunosuppressants to support the entire new drug development process. Currently, in response to the pharmaceutical industry\'s increasing reliance on outsourcing, we have established a system centered around highly knowledgeable and capable CRAs to provide fast and accurate data. Additionally, we have built a global support system for new drug development, using our Japan office as a hub to facilitate international joint clinical trials across Asia, Europe, and the United States. We also place a strong emphasis on employee education, continually enhancing our training systems to ensure ongoing skill development.
Responsibilities: 顧客重視のリーダーシップを持ち、PhaseⅠからPhaseⅣまで複数の臨床研究試験を管理する。
グローバルチームと連携し、日本やアジアプロジェクトチームおよび他部門との協業，調整，進捗管理を行う。
プロジェクトのリソースを調整し、契約や予算を遵守するよう管理する。必要に応じてChange Orderを顧客へ提案し、締結するよう調整する。
顧客、グローバルチームやベンダーの要望を考慮し、目標達成するようアクションおよびタイムラインを計画し、管理する。
BidとProposalなど事業開発活動をサポートする。
リスクマネジメントベースで、複数のサイト/国で指摘されている潜在的な傾向に関する最新情報を提供し、上級管理者および顧客とともに防止策について議論する。
PMのラインマネジメントを行い、PMをサポートし指導する

PMSグループマネージャー

市販後調査の管理業務に関する知識と経験が活かせます。

6 - 11.5 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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: GPSP規制に準拠したPMS（市販後調査）を計画し、計画通りに適時実施し、薬剤再審査制度の下で再審査用の資料を適切に準備する
再審査用資料の準備と検査対応の準備をリード/管理する
ローカルの定期安全性報告書の準備を確実に行い、GPVのグローバルプロダクト責任者とのレビューサイクルを調整する
ローカルの検査対応の準備を確立し、必要に応じてPV監査およびPV/GPSP検査に参加し、必要に応じてCAPAプロセスに貢献する
NBIの全メンバーが規制を遵守し、患者の医療安全性のギャップを継続的に埋めるために、短期および中長期の視点から戦略の開発と実施をリードする
業務プロセスの効率性、透明性、コンプライアンス、および洞察力を確保するために、クロスファンクショナルな協力とデータ活用を通じて業務プロセスの改善をリードする
安全性および規制の専門家だけでなく、自らとチーム、主要なステークホルダーを積極的にリードできる個々の能力を強化し、魅力的な環境を提供することをリードする
国内外の学術動向および臨床ニーズに基づき、患者の医療ニーズを継続的に満たすために、短期および中長期の視点からPMS戦略を計画および実行することをリードする
顧客中心のアプローチを通じて、HCP（医療従事者）および患者にとって価値のある科学的証拠を提供することを確保するために、会社およびグローバルな協力（例：戦略およびオペレーションとの協力）を計画する
PMSの一環として収集されたRWE（リアルワールドエビデンス）の使用に関して、MAおよびMKTチームと連携した戦略的設計をリードする。疫学チームと共同でデータベースおよび分析の戦略的設計をリードし、将来のコミュニケーションに備える
PMS活動からの洞察を収集、分析し、組織内で適切に共有されることを確保する
顧客エンゲージメント活動をサポートする適切な機能と連携し（例：S&O、MA）、継続的にコミュニケーションを保持し、CE（顧客エンゲージメント）とそのKPIの改善を可能にするインターフェースまたはプラットフォームを確立することにより、ポジティブな顧客体験を確保するなど

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