Jobs list of Pharmaceutical
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Job number: Job-00205978 Posted: 2023-06-15
臨床開発業務（クリニカルプログラムマネージャー）
グローバル開発戦略の策定に携わって頂けるポジションです！8 - 13 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a global pharmaceutical company with its own distribution channels around the world.
- Responsibilities
- 以下のいずれかの業務にあたっていただきます。
①クリニカルプログラムマネージャー臨床試験（治験）の実施と日本・アジアでの承認申請を行う実務責任者。海外チームと連携してグローバル開発戦略を作成し、社外オピニオンリーダー、研究部門、技術部門、グローバルマーケティング部門等と連携しながら臨床開発計画の立案、臨床試験計画立案・実施、PMDA・アジア各当局に対する相談・承認申請の中心的役割を担う。また、導入候補品の評価なども行う。
②スタディーマネージャー臨床試験（治験）の実施と日本・アジアでの承認申請を行う。特に臨床試験の実施に際してチームメンバー（モニター）の指導・管理、CROの管理、社外オピニオンリーダーとのコンタクトを行う。またクリニカルプログラムマネージャーと共同し、海外チーム、研究部門、技術部門、マーケティング部門等とコンタクトをしながらグローバル開発戦略の作成、臨床開発計画の立案、臨床試験計画立案・実施、PMDA・アジア各当局に対する相談・承認申請を行う。
③プロジェクトマネージャーグローバルプロジェクトリーダーと連携し、グローバル開発戦略・計画を策定する。また、国内・海外の複数部門のメンバーで構成されるグローバルプロジェクトチームの活動をマネジメント（タイムライン管理、予算管理、リスク管理、問題解決等）する。
Martin Tsvetkov
Pharma -
Job number: Job-00264107 Posted: 2024-04-17
＜研究開発・メディカルアフェアーズ統括本部 安全性情報部＞ Clinical Case Management(担当/担当課長/課長) 神戸本社 ・東京支社
PV position at global maker with strong pipeline8 - 15 million yen Kansai Pharmaceutical Pharmacovigilance
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- 適切な安全性情報・不具合情報収集のためのプロセスを統括管理する
CROと協働して、収集した情報を安全性システムで管理し、それらの評価およびPMDAへの報告を行う
アライアンスパートナーと連携し情報収集・共有を行う
市販後の規制要件を遵守し、成果を達成する（成果物；個別症例報告、安全性定期報告、再審査申請など）
PMDA等による外部査察や社内監査に対応する
テクノロジー（AI、RPA）利用による業務の効率化を推進する
アメリカ本社主導の改善活動やglobal projectに参画して日本としてのインプットや日本案件projectを推進する
その他、安全性情報部内の様々な組織改善活動に貢献する
Yui Osone
Pharma -
Job number: Job-00266166 Posted: 2024-04-19
Rheumatology Brand Marketing
Marketing position at mega pharma with strong pipeline8 - 12 million yen Kansai Pharmaceutical Marketing
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- Leads the development of marketing programs, materials, and other activities to deliver exceptional customer experiences based on insights and data for product indications. Partners with other functions, as well as external players (e.g. KOLs, societies) in the execution of these customer experiences.Analyze data and gather customer feedback (market research, ad boards, field) and market intelligence to inform strategy.
Develop brand strategy, including customer experience and message localization.
Informs brand strategy and solutions development and localizes marketing tactics with an omni-channel mindset and simplicity in execution.
Manages OPEX, coordinating with Finance to identify ways to maximize resources and benefit the most patients.
Identifies and engages thought leaders and develops speakers in partnership with P2P, sales and medical.
Leverages sales as main promotional channel and ensures the sales force drives the desired customer experience through an omni-channel approach.
Yui Osone
Pharma -
NEWJob number: Job-00267735 Posted: 2024-04-26
Pharmacoepidemiology Scientist
Position at global mega pharma with very strong pipeline8 - 14 million yen Tokyo Pharmaceutical Data Management / Biostatistics
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- Responsible to lead safety observational studies as scientific lead and to deliver deliverables
Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice)
Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective.
Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases)
Review and develop study report/publications.
Lead scientific discussion in cross functional team and in discussion with regulatory agency.
Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence.
Support non-regulatory mandatory safety observational studies
Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies.
Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders.
Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle
Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products.
Contribute to Japan Risk Management Plan (RMP) development, periodic report development.
Review and develop query response to regulatory authority.
Demonstrate knowledge of relevant global and local regulatory requirements and practices
Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities.
Contribute to organizational RWE capability development
Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology.
Provide pharmacoepidemiology related trainings.
Support system/process development to enhance productivity or increase scientific quality.
Obtain up-to-date pharmacoepidemiology approach/knowledge
Yui Osone
Pharma -
Job number: Job-00254746 Posted: 2023-09-07
【東京】開発薬事 マネジャー/担当部長 ～JASDAQ市場グロース上場～
製薬メーカーでのマネジャー～担当部長ポジションです8 - 15 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- The company is a pharmaceutical manufacturer that actively develops orphan drugs.
- Responsibilities
- ■職務概要：
がん、血液領域、ウイルス感染症を中心に希少疾患領域の開発を目指すJASDAQ市場グロースに上場の製薬企業の開発薬事マネジャー～担当部長ポジションです。
■職務内容： 国内の薬事関連法規・通達等の調査・検討、開発計画に対する薬事的戦略及び承認申請戦略の立案
治験計画届出、対面助言相談実施、製造販売業許可に必要な書類の作成・諸手続き
製造販売承認申請/一部変更承認申請のためのCTD資料作成及び承認申請関連の薬事関係書類の作成・諸手続き
添付付書の作成・諸手続き及び維持管理業務
薬価基準収載に係る申請資料作成・諸手続き
上記手続きに係る公官庁との連絡・折衝業務
各種プロモーション資材に対する作成支援業務
開発薬事業務に関係する手順書・マニュアルの作成・整備
Patrick Chang
Pharma -
Job number: Job-00217938 Posted: 2024-04-10
Clinical Trial Manager
CTM8 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a clinical-stage biotechnology company.
- Responsibilities
- 臨床試験マネージャーは、治験の開始からデータベース管理まで、臨床業務に従事していただきます。
臨床試験における様々な側面を管理するマネージャーポジションです。
他部門との連携が多数発生します（アメリカ拠点との英語コミュニケーション有）。
定められた目標、タイムライン、予算、および適用される規制要件を順守し、治験の開始から割り当てられたデータベース管理までの臨床試験の運用面を監督します
Martin Tsvetkov
Pharma -
Job number: Job-00207377 Posted: 2024-02-24
Application Scientist
Pricing and HEOR Hybrid position8 - 110 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- Our client is a life sciences and materials science company.
- Responsibilities
- Provide scientific support to current and prospective customers, which includes demonstrating the optimal use of our life science software suites, facilitating interactions between customers and product development teams, and providing general scientific guidance
Engage in cutting edge scientific research and provide best practices for modeling automation to our customers
Consolidate the existing customer base
Publish scientific papers and present at conferences
Work from the Tokyo office when not traveling for company business
Martin Tsvetkov
Pharma -
Job number: Job-00210485 Posted: 2024-01-30
[Osaka or Tokyo] Medical Writer of Drug Development
Great Company Culture8 - 14 million yen Other Pharmaceutical Research & Development
- Company overview
- In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
- Responsibilities
- PREPARATION OF CLINICAL
TRIAL PROTOCOL- PREPARATION OF CLINICAL TRIAL SUMMARY REPORT
PREPARATION OF DRUG APPROVAL APPLICATION MATERIALS (CTD: COMMON TECHNICAL DOCUMENT) (CLINICAL PART ONLY)
PREPARATION OF INVESTIGATIONAL DRUG SUMMARY
REVIEW OF ABOVE-MENTIONED DOCUMENTS
CORRESPONDENCE BY AUTHORITIES (CLINICAL PART DOCUMENT CREATION, REVIEW, CONSULTING, ETC.)
GENERAL CONSULTING FOR DOCUMENT CREATION THAT MEETS REGULATORY REQUIREMENTS
CONTRIBUTING AS A LEADING ROLE IN THE ABOVE
APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS AND CONTRIBUTION TO MEMBER GROWTH
Patrick Chang
Pharma -
Job number: Job-00210486 Posted: 2024-02-19
[Osako or Tokyo] Drug Safety Associate
New Position with Exciting Salary8 - 14 million yen Other Pharmaceutical Pharmacovigilance
- Company overview
- Our client is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
- Responsibilities
- THE DRUG SAFETY ASSOCIATE WILL WORK ON SAFETY EVALUATION WORK FOR PHARMACEUTICAL PRODUCTS (INCLUDING INVESTIGATIONAL PRODUCTS), MAINLY INDIVIDUAL CASE EVALUATION, CASE PROCESS WORK AND RELATED WORK
UNDERSTAND THE OPERATION OF THE SAFETY DATABASE AND THE SYSTEM NECESSARY FOR THE WORK, AND CREATE MANUALS, ETC. AS NECESSARY.
RESPONSIBLE FOR-FAMILIARITY WITH SAFETY INDIVIDUAL CASE EVALUATION WORK IN COMPLIANCE WITH GVP AND SOP, AND INSTRUCTING OTHER MEMBERS
PROPOSING MEASURES AND IMPROVEMENT POINTS FOR PROBLEMS THAT MAY AFFECT BUSINESS PROCESSES, ETC.
COMPLIANCE DOCUMENT BY REGULATORY AUTHORITIES COOPERATE IN PREPARATION AND RESPONSE TO SURVEYS, ETC.
Patrick Chang
Pharma -
Job number: Job-00209314 Posted: 2023-06-15
早期臨床開発機能におけるクリニカルリーダー
早期臨床開発機能におけるクリニカルリーダー8 - 13 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a biopharmaceutical company.
- Responsibilities
- 適応疾患の検討およびbiological PoC試験のデザインを含む臨床開発計画（CDP）の⽴案
開発段階に応じたTPP(Target Product Profile）の策定
試験プロトコル骨⼦の作成
海外カウンターパートや領域エキスパートなど国内外ステークホルダーとの交渉
デジタル技術を活用した開発戦略の策定
グローバルの臨床チームを統括して、早期臨床試験を推進する
CRO/Vendorオーバーサイト
Patrick Chang
Pharma -
Job number: Job-00209437 Posted: 2023-06-15
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
- Our client is a cutting-edge biotechnology company.
- 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）
Patrick Chang
Pharma -
Job number: Job-00209427 Posted: 2023-06-26
【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 developing and providing various medicines for an array of health concerns.
- 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
Patrick Chang
Pharma -
Job number: Job-00209419 Posted: 2023-06-15
開発薬事責任者
ニッチ業界で成長を続ける成長企業8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is providing drug development service.
- Responsibilities
- 部門の管理、人財マネジメント
営業活動
部門の予算管理
医薬品・医療機器関連の治験相談
メディカルライティング業務管理
医薬品・医療機器に関する法規制への対応業務
各国申請代理人との連絡・調整
当該国薬事規制等の調査
アジア地域における医薬品・医療機器開発戦略コンサルティング（各種試験成績・資料の評価、医薬品・医療機器承認申請に係る当局対応、申請届出等）
Patrick Chang
Pharma -
Job number: Job-00209436 Posted: 2023-06-15
医薬品の安全性管理業務統括（経営職）
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
- Our client is a cutting-edge biotechnology company.
- Responsibilities
- 市販薬および治験薬の安全性情報管理業務統括（RMP策定、安全確保措置の策定と管理、開発プロジェクトへの参画及び臨床研究部門との連携など）
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）
規制当局との対応業務（定期報告作成責務、再審査申請資料作成責務、照会事項、適合性調査対応業務など）
Patrick Chang
Pharma -
Job number: Job-00237820 Posted: 2023-06-15
【東京】自社開発品のマーケットインサイト担当(ビジネスアナリスト）
市場調査の全般的な知識をお持ちの方必見です!8 - 12 million yen Tokyo Pharmaceutical Marketing
- Company overview
- Our client is a biopharmaceutical company.
- Responsibilities
- 自社早期開発品の環境分析・市場調査活動を主導し、得られた患者さんのニーズをもとに製品価値向上を目指したマーケットインサイト(UMNs・Patient Journey・市場動向予測 等)の創出・提供
組織横断的チームマネジメントによる開発プロジェクトの各シナリオにおける売上予測、事業性評価（NPV分析）
Patrick Chang
Pharma -
Job number: Job-00209602 Posted: 2024-03-24
Regulatory Strategist
RA8 - 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
Martin Tsvetkov
Pharma -
Job number: Job-00210272 Posted: 2023-11-06
Medical Affairs PM
Medical PM8 - 14 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is a global healthcare corporation. Driven by its mission and aspirations, the organization is fully committed to safeguarding public health. This commitment is demonstrated through ongoing endeavors involving the research, development, importation, manufacturing, and distribution of medicines and vaccines. Its parent company is headquartered in the United States.
- 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.
Martin Tsvetkov
Pharma -
Job number: Job-00266310 Posted: 2024-03-29
ノンラインマネージャー
新薬登録を含むRA分野での5年以上の経験をお持ちの方必見です。8 - 11.5 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is a global pharmaceutical company.
- Responsibilities
- 内部インターフェース日本国内の各部門との情報交換および対話：規制問題、医療、法務、HP 供給およびマーケティング監督総局。
グローバル機能との情報交換と対話：グローバル規制問題、企業医療および資産チーム、グローバル品質。
外部インターフェース必要に応じて、保健当局、業界団体、ライセンスパートナーとの対話と交渉。
Martin Tsvetkov
Pharma -
Job number: Job-00204786 Posted: 2023-11-02
Senior Specialist Quality Assurance / PV Audit
Global Company8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- Our client is a global healthcare corporation. Driven by its mission and aspirations, the organization is fully committed to safeguarding public health. This commitment is demonstrated through ongoing endeavors involving the research, development, importation, manufacturing, and distribution of medicines and vaccines. Its parent company is headquartered in the United States.
- Responsibilities
- Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
Promotes standardization of auditing approach within QA.
May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
Provides inspection management support as appropriate.
Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
Martin Tsvetkov
Pharma -
Job number: Job-00254976 Posted: 2023-10-19
Associate Director Process Engineering
学際的なチーム環境での業務経験が活かせます。8 - 16 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- Our client is a research-based global pharmaceutical company.
- Responsibilities
- 反応・粒子工学の全側面を担当するエンジニアグループのリーダーとして、単位操作の研究のためのスケールダウンモデルの開発、プロセスの安全性評価、および外部製造受託機関への技術移転を担当します。理想的な候補者は、効果的にプロセスを開発/最適化/スケールアップ/トラブルシューティングするためのプロセス理解を強化するために、数理モデル（統計的および第一原理）と組み合わせてプロセス分析技術（PAT）を使用する深い経験を持っています。アソシエイト・ディレクターは、スケールダウン装置を構築し、バッチプロセスおよび連続プロセスの両方に対する革新的な高度プロセス制御戦略を開発した経験を有する。理想的な候補者は、パイプラインプロジェクトのサポート方法の継続的な改善に努め、デジタルツール、自動化、ロボティクス、またはコボティクスを活用して、プロセス開発、最適化、理解、製造への技術移転を促進し、加速するための新しいワークフローを開発します。
Patrick Chang
Pharma