Jobs list of Pharmaceutical

[Tokyo] Medical Science Liaison in Diabetes

Rich Pipeline and Expanding

5 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a global healthcare company.
Responsibilities: Identifies, lists and communicates with KOLs and HCPs in the practice setting (e.g., academic centres, investigators, IISs research site) to update their understanding of relevant data in each context related to products, as well as to build and maintain relationships to facilitate scientific exchange on topics of relevance to company.
Assists in identifying, engaging, and maintaining relations with KOLs and HCPs to establish and/or further the knowledge of products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.
Assists in identifying and responding to inquiries from KOLs and HCPs; assisting with identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest.
Gathers Medical insights regarding company and competitors’ products from KOLs and HCPs to help inform company decision-making bodies and update the Medical and/or Marketing Strategies if necessary.
Participates in assigned medical and scientific meetings to maintain awareness of current issues and new data pertaining to company and competitors’ products and to support medical booth in answering physicians’ scientific questions.
Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical Strategy.
Assists regional Medical Representatives (MRs) in handling scientific and clinical questions for company marketed products from KOLs and HCPs.
Support the on boarding of new MSLs where required.
Support clinical trials by driving scientific discussion at site selection and site initiation visits where required.
Support scientific dialogue with investigators at prioritized/requested sites and patient recruitment and retention of subjects where required.
Participates in a series of internal medical/scientific trainings and regular scientific assessments to maintain general scientific knowledge and awareness of new data pertaining to company and competitors’ products.
Complies with all guidelines, policies, legal, regulatory, and compliance requirements.

Medical Affairs PM

Medical PM

8 - 14 million yen Tokyo Pharmaceutical Medical Affairs

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: 1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
For US headquarters-led research, work with headquarters personnel to promote the project.

2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.

【品川】臨床開発職（癌スタディリーダー／スタディマネージャー）

国内トップクラスの製薬メーカー

6 - 11 million yen Tokyo Pharmaceutical Clinical Development

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: 研究開発本部における臨床開発職（癌クリニカルサイエンティスト）として、下記業務に携わっていただきます。
■業務内容：
（1）抗がん剤プロジェクトのスタディリーダーとして試験の推進、タイムライン等の進捗管理を行うことで、グローバルスタディを推進する。
（2）国内やアジアを中心とした臨床試験オペレーションをリーダー的な立場で推進する。能力によっては欧米における臨床試験オペレーション業務も担う。
（3）疾患領域特異的な知識、経験に基づいたオペレーション戦略立案、実行にむけたスタディチーム員・外部ベンダーとの専門的な議論を行う。

【品川】臨床開発職（癌クリニカルサイエンティスト）

医薬品臨床開発のクリニカルサイエンス業務の経験３年以上お持ちの方必見です。

6 - 11 million yen Tokyo Pharmaceutical Clinical Development

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: 抗がん剤プロジェクトのクリニカルサイエンティストとして、プロトコール、同意説明文書の作成・改定や、メディカルライター等と協働して総括報告書の作成等を行うことで、グローバルスタディを推進する。
国内やアジアを中心とした承認申請関連業務を臨床の立場で推進する。スキルによってはFDA等の承認申請関連業務を含む。
新規試験を中心としたグローバル開発戦略立案、開発戦略・臨床試験計画策定のための医師・KOLとの専門的な議論を行う。

Analyst

6 - 10 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR

Company overview: This is the exclusive business partner and adviser to biopharma senior management teams
Responsibilities: Demonstrated ability to be an important contact for the client in all communications
Ability to present independently to the client
Demonstrates strong understanding of assets that best fit the client
Ability to interact with partners and manage diligence requests
Able to trouble shoot assessment to evaluate target niches
Basic understanding of financial analysis and modelling, including DCF models and comparable transactions
Ability to author thought leadership pieces
Provide support in quality control and in ensuring the product is polished for Associate review
Having experience and understanding of the health care industry

[Janssen] Contract & Compliance Services, Site Engagement Analyst

Open to CRO CRA Candidates

6 - 9 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
Manage the contract amendment lifecycle.
Assume responsibility for all aspects of legal document and metrics tracking.
Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
Comply with requests from QA and auditors.
Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
Exemplary customer focus with vision to drive solutions

QM部品質システムグループ

Global Company

5 - 8 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: 1. 製品製造所及び原薬製造所の管理
製造業者等との取り決めを作成する
製造所の製造管理及び品質管理が適正に行われている事を定期的に確認する (GMP査察の実施)
製品に関する変更管理及び逸脱管理を確実に行う
薬機法で定義された事項について品質保証責任者へ報告す
品質に関する問題の解決にあたり、製造所または他の部門と協働する

2. HP Supply Japan における品質マネジメントシステム (QMS) の構築・維持
HP Supply Japan における QMS を構築・管理する
HP Supply Japan の他部門と協力し，local SOP と社内基準の調和を図る (OCP/OCS 等の落とし込み)
製品に関する品質標準書の作成を行う
GQP省令で定められた品質管理業務手順書の作成を行う
記録及び文書を適正に維持管理する
製品の品質照査を実施する
HP Supply Japan における GDP を維持・管理する
KPI等の Quality に関する情報をタイムリーに集計し、報告する

3. 製品を市場へ出荷する
製造所における製造管理及び品質管理の結果を適正に評価すると共に，市場への出荷を適正かつ円滑に行う

4. 品質に関する情報、品質不良及び回収に関する業務を行う
市場からの品質苦情について調査・分析を行い、必要に応じて製造所に改善を指示する
入手した品質情報，品質不良について，原因調査及びその評価を行い，改善策を策定する
製品回収において，必要な対応を迅速に調整・実施する

5. Corporate 及び HP Supply Japan プロジェクトへの貢献
corporate主導のプロジェクトに関する情報を収集する
関連する corporate主導のプロジェクトや会議に積極的に参加・貢献する
HP Supply Japan が進めるプロジェクトへ貢献する

6. 東日本及び西日本 DC での GMP 品質部門として機能する
DC GMP を維持・管理する Establish and maintain DC GMP.
DC での輸入製品の GMP 出荷業務を行う

【静岡／鎌倉】非臨床DMPKリーダー

創薬の非臨床薬物動態研究での実務経験3年以上お持ちの方必見です。

6 - 9 million yen Kanagawa Pharmaceutical Research & Development

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: 創薬テーマのDMPK機能リーダーとして、担当テーマのDMPK及び生体試料分析の課題を関連部署と協働して解決し推進する。
技術課題解決のための新技術確立、ならびにアカデミアや海外関連会社との共同研究を通じた外部からの技術導入の推進役を担う。

【埼玉】新薬開発プロジェクトマネージャー

CMC関連の研究または薬事の実務経験をお持ちの方必見です。

6 - 10 million yen Saitama Pharmaceutical Regulatory Affairs

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: 同社は現在、豊富な開発パイプラインのもと、グローバル臨床開発を実施する一方で、海外企業・ベンチャーとのパートナリングによる共同開発も進行しています。この様な環境のもと、CMC開発・外部パートナーとの連携が年々複雑化しており、開発プロジェクト管理の重要性が益々大きくなっています。
そこで、CMCに特化したプロジェクトマネージャーを配置し、臨床開発のプロジェクトマネージャーと連携しながら、開発及びLCMプロジェクトの進捗管埋、種々の問題点の解決・リードを進めており、今回上記業務を担当いただける人財を募集します。

【東京】セイフティオペレーションマネージャー（スタッフ or シニアスタッフ）

PVに関連する業務経験3年以上ある方必見

5.5 - 9 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: ヘルスケアに関する製品およびサービスの提供を行う当社において、安全性情報に関わる下記業務をご担当いただきます。
業務詳細：
・ファーマコビジランス部門と協力し、個別症例処理業務を行っているベンダー管理（進捗管理、リソース確保および品質維持）
・上記に係る手順書の作成および改訂
・安全性データベースをアップグレードなどによるプロセス変更の影響を評価し、プロセスを改善および構築する
・同社内のクロスファンクショナルなプロジェクトやタスクフォースのプロジェクトマネジメント
・オペレーションスペシャリストとしてのDXなどを組み込んだ同社における効率的なプロセス構築、改善の実施

【東京／浮間研究所】注射剤処方開発・物性評価担当者

バイオ医薬品の物性に関する知識お持ちの方歓迎

6 - 12 million yen Tokyo Pharmaceutical Research & Development

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: ■業務内容：
注射剤の有効成分となる主薬分子の安定性に関与する因子 (物性、相互作用、等)を解明する
優れた安定性を有する注射剤処方を設計する

【変更の範囲：会社の定める業務】
■魅力：
製剤化を通して付加価値を向上し、世界中の患者さんに届けることで世界の医療に貢献できる。

Manager, Bio-Statistician

Global Company

10 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
Communicate and collaborate with global statisticians on assigned projects.
Provide a strong statistical presence in regulatory and professional circles.
Participate in research on statistical methodology and its applications to clinical trials/PMS.

【東京】コマーシャルマネージャー（循環器・メタボリズム・眼科領域）

製薬会社での業務経験があるご活躍いただけるチャンス

8 - 12 million yen Tokyo Pharmaceutical Marketing

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: コマーシャルマネージャー／新製品企画（NPP）は、特定の疾患領域（DA）を担当し、パイプラインの「エンド・ツー・エンド」の新規フランチャイズおよび製品戦略を構築する重要な役割を担っていただきます。血栓症、非アルコール性脂肪性肝炎（NASH）などを含む循環器・代謝領域、遺伝性網膜疾患などを含む眼科領域など、複数のDAをリードしていただけることを期待しております。また、戦略的コマーシャル機能の代表として、グローバルおよび地域のステークホルダーとのコミュニケーションの窓口となることが求められます。
主な職務内容：
循環器領域、代謝領域、眼科領域の化合物について、研究開発部門とともに化合物戦略を策定
ラベリング機会の最大化、レギュラトリーパスウェイの加速、パイプラインの優先順位の最適化
アンメットメディカルニーズとエビデンスギャップの発見
包括的な市場参入戦略の策定、ローリングビジネスサイクルに沿った予測と予算計画
診断薬のビジネス価値を関連化合物とともに確立
ローカルかつリージョンビジネス開発戦略を開発するためのパートナーとなり、BD活動をサポートするための商業的専門知識を提供
上市チームのリーダーとして、担当化合物の新製品の上市をサポート
患者の予後を改善するため、テクノロジーを活用したソリューションを実施

Regulatory Strategist

RA

8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
Responsibilities: Build a registration strategy for efficient product development in Japan to get fast approval of new projects (new product, new indication, new dose & administration, new formulation, etc.).
Coordinate the relevant functions to prepare the documents which should be submitted to PMDA and/or MHLW such as the documents relevant to PMDA consultation and Orphan Drug Designation.
Support the dossier manager to lead the relevant functions to prepare the required documents for NDA/sNDA submission and answer documents to inquiries during NDA/sNDA review by PMDA, and conduct the following activities.
Ensure other functions to prepare the documents to be submitted to Health Authority on products.
Contribute to the global regulatory activities on projects in charge by inputting regulatory strategy in the global regulatory strategy.
Provide Global Regulatory Team (GRT) with the Japanese legal/regulatory requirements and Japanese development strategies if necessary.Graps the regulatory information such as HA’s movement, legal requirement on NDA/sNDA guidelines, etc

【薬事課】薬事・MF担当（管理職候補）◆MF申請、照会事項などのチーム管理

海外取引比率約60％・世界約90ヶ所の国や地域との取引実績あり／大手G中核企業

10.2 - 13 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Our client is an organic chemicals business company.
Responsibilities: ■業務概要：
薬事課の薬事として、MFの申請、照会事項への対応、変更管理、海外製造所へのGMP適合性調査対応、外国製造所認定および更新を管理し、課員をリードしていただきます。

■入社後の業務：
課の責任者として，各プロジェクトの管理，課員の労務管理，社内外の関係者との調整を行っていただきます。

■薬事部の特徴：
医薬品の品質および安全性を確認する上で重要な品質管理業務については、自社で保有する試験室において海外の医薬品原料を厳密に試験し、安全且つ安定的に日本の製薬メーカーに供給できる体制を構築し信頼を得ています。

[Osaka or Tokyo] Clinical Team Manager

Strong Global Foot Print and High Salary

9 - 15 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: BUILD RELATIONSHIPS WITH CLIENTS AND LEAD
PROJECTS BY COLLABORATING WITH PROJECT MANAGER (GLOBAL PM OR REGIONAL / LOCAL PM) AND OTHER DEPARTMENTS (INCLUDING PARTNER VENDORS) AS NEEDED -CRA FOR EACH PROJECT, IN-HOUSE CRA, PROJECT LEADS SUCH AS CONTRACTS ASSOCIATE AND START-UP LEAD
MANAGEMENT OF QUALITY, TIMELINE, AND BUDGET IN MONITORING
PROACTIVE RISK MANAGEMENT
CONTRIBUTING TO GROWTH WITH APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS

【東京】CTL（クリニカルチームリーダー）

臨床開発のモニタリング経験者必見です!

6 - 8 million yen Tokyo Pharmaceutical Clinical Development

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: 治験実施計画書、同意説明文書及び症例報告書の作成（補助）
モニタリング計画書等、各種手順書の作成
モニタリングおよび施設対応の実施責任者として、モニターを指揮して治験を実施
モニタリング報告書・必須文書・症例報告書等の確認
担当試験に係わるチーム内（モニター）教育

【東京】臨床開発プロジェクトマネージャー

臨床開発プロジェクトマネージャー経験者必見です!

6 - 9 million yen Tokyo Pharmaceutical Clinical Development

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: 臨床開発プロジェクトのスケジュール・リソース・コスト管理
社内意思決定プロセス管理
関連部門（臨床開発、薬事、非臨床、CMC等）で構成されるプロジェクトチームのコミュニケーションマネジメント
共同開発先・導出入先との協業プロジェクトのアライアンス業務
歓迎条件:
海外スタッフを含むグローバルチームでの業務経験
上級レベルの英語コミュニケーション能力（グローバルチーム会議をファシリテートできる会話能力）※海外拠点や海外他社協業先とのグローバルプロジェクトの担当機会あり
抗がん剤領域の新薬開発経験
プロジェクトマネジメント管理ソフトの使用経験（例：MS-Project、Planisware等）
Project Management Professional （PMP）資格

メディカルアフェアーズ本部　肺高血圧症疾患領域スペシャリスト

6 - 10 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: Responsible to develop the Medical Affairs product strategy through the analysis of medical needs collected from all internal & external stakeholders of the therapeutic area
Responsible for managing MAF study / publication portfolio in alignment with brand strategy
Responsible for people and operational budget management of PH (Pulmonary Hypertension) therapeutic area
Day to day project management for activities based on the Medical Affairs Plan in responsible disease areas
Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC (Healthcare Compliance) rules.

品質保証 QA

Global Company

6 - 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: 医療機器、再生医療製品等を含む新たなモダリティへの業務展開
新たな技術の導入、技術の進化
サプライチェーンの多様化

グローバル製品（開発品・市販品）の増加
製造委託先、試験委託先ならびに原材料供給業者の増加
そのため、GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務に精通した要員の補充が必要となった。

IND/IMPD、NDA/BLA作成及び推進、国内申請資料作成及び推進、その他CMC薬事にかかわる業務

Jobs list of Pharmaceutical

Change filters