Jobs list of Pharmaceutical & Clinical Development

提案書作成業務

バイオテクノロジーを用いた医薬品開発、製造に関する基礎的な理解がある方必見です。

6 - 11 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We are a leading comprehensive glass manufacturer in Japan. Our business extends beyond glass to include electronics, chemicals, and ceramics, resulting in a well-balanced revenue composition that makes us resilient even in economic downturns. We develop and manufacture innovative materials and products across a wide range of fields, leveraging our high technological expertise and research and development achievements. We supply products to various industries such as construction, automotive, electronics, and medical equipment. Furthermore, we are committed to environmental conservation and the development of sustainable technologies, earning us recognition as a socially responsible company.
Responsibilities: 世界中のお客様から受領した開発・製造委託の提案書作成依頼（RFP:Request for Proposal)の内容を分析する
主に千葉工場の技術チームなどと綿密に連携し、お客様に提出する提案書の作成を行う
グローバルの価格決定会議に参加し、提案内容の発表を行い、承認を得る
主に千葉工場や、ウェブなどで、お客様との会議に参加し、提案書の説明、協議を行い、提案書の改訂作業を行う
より競争力のある提案書を作成するため、主に千葉工場の技術チームやグローバルのチームと一緒に、改善活動を行う

Senior CRA

全力で仕事に取り組む社員／自ら働き方を選べる

0 - 0 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a global pharmaceutical company with offices across 81 countries.
Responsibilities: Main responsibilities:
For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
Anticipate and identify site issues that could affect timelines and develop alternative solutions.

Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise.
Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.

Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.

Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements.
Prepare and follow up site audits/inspections; provide input into the CAPA preparation.

Responsible for coaching and mentoring CRAs and providing input into their development.
Responsible for mentoring CRAs for various aspects of work.
May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives. Responsible for activities as
assigned by manager.If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
If assigned; With guidance, may serve as key point of contact in country/district for assigned study.

Update Impact/Tesla with country-level information: Country-level planning timelines, LSR
assignments, etc.If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives.

Provides feedback on investigators/sites on an on-going basis based on the site performance.
Interacts and builds professional and collaborative relationships with peers and site monitors.

臨床開発計画の立案を担うクリニカルサイエンスリーダー

製薬メーカー等での臨床開発業務経験が活かせます。

11.1 - 12.6 million yen Tokyo Pharmaceutical Clinical Development

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: Immunology領域における臨床開発計画の立案（後期開発品における市場価値最大化の検討含む）
臨床試験のプロトコルの策定
当局相談資料や申請資料などRegulatory Agenciesとの対応と方針の決定
国内外Key Opinion LeaderおよびRegulatory Agenciesとの折衝
導入候補品の臨床科学的評価
臨床試験の外部への発表に関する業務

メディカルアドバイザー

臨床または研究環境におけるTAの経験、理想的には肝臓病学、心臓病学および腎臓病学をお持ちの方必見です。

6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

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: 臨床開発フェーズの全プロセスを通じて、担当治療領域における医療／科学的な確固たるガイダンスを提供することで、当社製品のプロファイルを強化
規制／臨床開発チームと協力し、それぞれの製品の日本での申請と登録を確実にサポート（PMDAの問い合わせへの対応準備など、承認までの臨床部分をサポート）
当社のグローバルな開発戦略と一致する形で、日本の臨床開発計画を策定し、当社グローバル医学に認知されるようにする
治療領域における全体像（リソース/予算の観点からの全プロジェクト/試験）に基づき、Nippon Boehringer Ingelheimが開発／データ構築の決定を行うことをサポート
概念実証後および商業化の後期段階における臨床データパッケージ（CDP）への貢献
マーケティングおよびマーケットアクセスと共に、日本特有のニーズに対応するための統合アセットプランおよび詳細な年間コミュニケーションプランを準備し、グローバルIBP（統合ブランドプラン）と一致させる
臨床／前臨床研究、研究者主導の研究およびRWE（リアルワールドエビデンス）研究を通じて外部の専門家との協力により新しい科学的証拠を構築
製品の利益／リスク評価への貢献
MSL（メディカルサイエンスリエゾン）と共に外部専門家からの洞察を得て、医療戦略を提案

メディカルアドバイザー

臨床または研究環境でのTA経験をお持ちの方必見です。

6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

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: 治療領域（TA）戦略に沿った日本におけるCDMA（臨床開発および医療業務）活動を、前臨床開発の開始から商業化の後期段階まで遂行するために貢献いただきます。
担当領域：心不全・CKD領域

メディカルアドバイザー（肥満症／MASH領域）／ノンラインマネージャー or スタッフ

生命科学における修士号お持ちの方歓迎

6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

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: ■業務概要：日本におけるCDMA（臨床開発およびメディカルアフェアーズ）活動を、TA（治療領域）戦略に基づき、前臨床開発の開始から商業化の後期段階まで実行することに貢献いただきます。担当領域：肥満症／MASH領域
■担当業務：当社製品のプロファイルを強化するため、臨床開発フェーズ全体にわたり、グローバルのコーポレートおよび他部門と協力して、担当する治療領域における医学的／科学的な堅実なガイダンスを提供
規制／臨床開発チームと協力して、該当する製品の日本での申請および登録を確保・サポート（PMDAからの照会への対応準備など、承認までの臨床部分をサポート）
同社グローバルメディスンによって認識され、グローバル開発戦略と一致する、日本の臨床開発計画を策定する責任を負う
治療領域における全体像（リソース／予算の観点からのすべてのプロジェクト／試験）に基づいて、同社が開発／データ構築の意思決定を行うのをサポート
概念実証後および商業化の後期段階におけるCDP（Clinical Data Packages）への貢献
マーケティングおよびマーケットアクセスと協力し、日本の特定のニーズに対応するための統合資産計画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IBP（Integrated Brand Plan）と整合させる
臨床／前臨床研究、研究者主導研究およびRWE（Real World Evidence）研究を通じて、外部専門家との協力により新しい科学的証拠を構築
製品の利益／リスク評価への貢献
MSLとともに外部専門家からの見識を得て、医療戦略を提案

薬事コンサル（最先端医療技術のコンサルティング業務）

薬剤師、獣医師の資格をお持ちの方必見です。

6 - 10 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a provider of medical-related services through the Internet.
Responsibilities: AIプログラム医療機器や遺伝子治療など、最先端医療技術の薬事支援コンサルタント業務国内外のベンチャー企業や新規参入を目指す異業種企業が開発する最先端医療技術の社会実装を薬事の面から支援します。薬事戦略や開発ロードマップ、事業化マスタープラン等の策定
規制当局（PMDA及び厚労省）対応、PMDA対面助言等の代行
対面助言資料やオーファン指定申請書など、各種薬事関連書類の作成
AMED等のグラント申請支援
上記に係るコンサルテーション、文書作成（翻訳含む）、プロジェクトマネージメント

Clinical Project Manager / Clinical Leader

Global Trail and high salary

8.5 - 17 million yen Tokyo Pharmaceutical Clinical Development

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: Manage Clinical Trials

Project Manager

社員の成長を大切にする企業／オープンカルチャー

10 - 18 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a global pharmaceutical company with offices across 81 countries.
Responsibilities: Main responsibilities:
Main activitiesSupporting the growth of team members
Complying with and enforcing industry and company rules
Budget management for assigned projects
Responsibility for conducting evidence meetings in each disease area
ESG budget management
Influence related departments, joint companies, and external stakeholders and build trust
Smoothly carry out assigned tasks such as research with high expertise
Appropriately manage the progress of reexamination applications and submit applications within
the deadline.

Evidence Solution Project DutiesActivities to generate evidence (data) required or needed by patients or medical professionals by conducting tests and investigations,
The main task is project management from the decision to conduct a study to publication.
In general, this is similar to the PMS work under GPSP, but Companys unique feature is that it covers not only GPSP PMS but also studies conducted by Medical Affairs.
Integrated management of evidence generation projects (including publications)

Project Progress/BudgetAll evidence generation projects involving the Medical Headquarters
Act as a liaison between internal and external stakeholders in evidence generation activities
Responsible for creating an environment in which the team can act as a think tank for internal and external regulations related to evidence generation activities, and sharing and thoroughly disseminating information (including education) to necessary internal stakeholders
Manage budgets as project owner
Facilitate cross-sectional projects within the Evidence Solutions Group
Facilitate cross-sectional projects within the Evidence Solutions Group for the therapeutic area in charge
Improve the quality of the team so that the evidence generation department of Company
Medical Headquarters becomes the best model representing the industry

Early Evidence Lead・CPL（肺線維症・呼吸器領域 )ノンラインマネージャー

臨床開発業務の経験が活かせます。

6 - 12.6 million yen Tokyo Pharmaceutical Clinical Development

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に沿った国内臨床開発プランの作成
国内での申請・承認関連業務の確実な実行
各プロジェクトの質を担保し，タイムラインに沿って進行できるような適切なマネジメント
開発/データ創出に関しての説明責任（Early evidence leadとしてアセットの開発をリード）
開発段階における安全性に関連する重要な情報を関係者に適時共有
適切な薬価を取得できるような協力
メディカルアフェアーズおよびビジネス関連部門への情報移行
国内エキスパートとの関係構築
Global本社（Ingelheim, Germany)で開催されるglobal会議への参加

トランスレーショナルサイエンティスト

オンコロジー領域における３年以上の薬理研究、あるいはトランスレーショナル研究経験と専門知識を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: グローバルトランスレーショナルサイエンスリーダーとして、サイエンティストと共同で、臨床開発戦略と整合したトランスレーショナルサイエンス全体戦略の策定・実行
あるいは、グローバルトランスレーショナルサイエンスリーダーとの連携による担当癌種、臨床試験におけるトランスレーショナルサイエンス戦略策定と実行
各種トランスレーショナルサイエンス関連業務の担当者・専門家との共同を通じた非臨床・臨床とトランスレーショナルサイエンスデータの解釈・成果物の創出
プロジェクトチームへの戦略・成果物の説明、意思決定への貢献
外部専門家との共同研究戦略策定の議論、方針決定、推進

Country Study Start Up ( Specialist )

社員が成長を実感できる会社／革新的な製品が魅力の一つ

7 - 10 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a global pharmaceutical company with offices across 81 countries.
Responsibilities: Main responsibilities:
Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites
Establish the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
Proactively identify and communicate issues impacting delivery and providing proposed solutions.
Attend regional/area start up calls and providing input for assigned sites/studies
Collection of essential documents from sites and completing quality check (ALCOA)
Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements
Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation
Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
Trigger clinical supply shipments
Complete IP release activities and triggering IP shipment
Issue site green light letter and activating sites in IXRS
Track all start up and maintenance related activities in Vault SSU as appropriate
Maintain local country and site intelligence database and EDLs in Vault.
Maintain SSU performance metrics and KPIs for assigned sites/studies.
Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
Ensure audit/inspection readiness
Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
Participate in process improvement initiatives as required

CPL職（免疫領域）

社内外のステークホルダーとのコミュニケーション能力に長けている方必見です。

6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

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に沿った国内臨床開発プランの作成
国内での申請・承認関連業務の確実な実行
各プロジェクトの質を担保し，タイムラインに沿って進行できるような適切なマネジメント
開発/データ創出に関しての説明責任
開発段階における安全性に関連する重要な情報を関係者に適時共有
適切な薬価を取得できるような協力
メディカルアフェアーズおよびビジネス関連部門への情報移行
国内エキスパートとの関係構築

医薬品開発におけるプロジェクトマネジメント業務

5年以上の新薬の開発経験をお持ちの方必見です。

6.86 - 12.6 million yen Tokyo Pharmaceutical Clinical Development

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: 開発プロジェクトのプロジェクトマネジメント業務：
下記の活動を通じてプロジェクトを計画通り推進する。開発プロジェクトのタイムライン、予算、リソースを策定、管理する。
開発計画に影響を与えるリスクを特定し、リスク軽減計画を策定し実行する。
部門や地域を超えたプロジェクトレベルのコミュニケーションを促進する。プロジェクトチームのアクションログ、決定事項を文書化し管理する。
プログラム横断的なベストプラクティスや教訓を共有し、チームのパフォーマンスを最適化する。

【関西】臨床開発モニター

＜ベテラン歓迎／製薬メーカー配属／東証一部上場グループ＞

7 - 8.5 million yen Osaka Pharmaceutical Clinical Development

Company overview: -
Responsibilities: 同社社員として、内資・外資大手製薬メーカーに常駐し、臨床開発業務を担当します。具体的には、治験実施医療機関の調査選定・契約手続き、実施状況調査・確認、データ収集を行います。メーカー社員と同範囲を担うため、モニタリング以外の部分にも携わることが可能です。

クリニカルリサーチ（海外担当）／内視鏡AIの共同臨床研究の交渉や実施など

海外の医療業界におけるご経験をお持ちの方必見です！

8 - 12 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a Japanese AI solutions company specializing in the healthcare sector. With expertise in medical data analysis and advanced AI algorithm development, they are dedicated to addressing key challenges in the healthcare field. Their solutions contribute to optimizing diagnostic support, treatment planning, and overall healthcare efficiency. Much of their investments go into the development of AI solutions for health-related applications, encompassing areas such as patient monitoring, predictive analytics, and overall health management/support.
Responsibilities: 米国、南米、アジア（シンガポール、韓国、香港、タイ、ベトナム）、欧州（ドイツ、フランス、ポルトガル）の海外医療機関と実施する内視鏡AIの共同臨床研究の交渉や実施及び、論文作成の支援をご担当いただきます。上記対象エリアの共同臨床研究の立案、実施
提携先医療機関との戦略の立案（学会対応やハンズオンセミナー開催など）

[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

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

Global Pipeline with Work Life Balance

4 - 10 million yen Osaka 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

癌クリニカルサイエンティスト

海外支社への出向や中長期出張によるグローバルタレント育成も考慮する

7 - 12 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: 業務内容：
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および改定、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。能力によっては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

Jobs list of Pharmaceutical & Clinical Development

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