Jobs list of Pharmaceutical
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Job number: Job-00267071 Posted: 2024-04-25
Quality Assurance Senior Manager
Full Remote QA Senior Manager position12 - 15 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- The company is a foreign-affiliated pharmaceutical company.
- Responsibilities
- Provide strong support team management for GQP Head on day-to-day basis
Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS
Perform other duties as assigned such as described below, but are not limited to:Provide support for regulatory agency inspection readiness and requests
Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
Support business develop
Yui Osone
Pharma -
Job number: Job-00267971 Posted: 2024-04-25
医薬品／医療機器に関する薬物動態評価及び承認申請業務
創立70年超／年休125日／東証プライム上場企業／就業環境が良く、ワークライフバランス◎6.8 - 9 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- Our client manufactures and sells ethical pharmaceuticals and medical devices.
- Responsibilities
- ■業務内容：医薬品／医療機器に関する薬物動態評価及び承認申請業務
■業務詳細：開発化合物選定のための薬物動態評価
開発化合物の治験／承認申請用の薬物動態パッケージ策定及び試験の遂行
臨床試験におけるバイオアナリシス（薬物濃度、バイオマーカー、抗薬物抗体）
各種申請用資料（IB、CTD等）における薬物動態パート作成
【業務内容の比重】医薬品及び医療機器の薬物動態評価計画の策定：20％
医薬品及び医療機器の薬物動態評価：60％
承認申請業務：20％
■応募者のポジション：次期管理職候補
Patrick Chang
Pharma -
Job number: Job-00266963 Posted: 2024-04-23
Senior Brand Marketing Manager
Senior Brand Manager at global mega pharma12 - 17 million yen Tokyo Pharmaceutical Marketing
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- Specific responsibilities of the role include, but are not limited to:
Develop launch strategy, lead commercial activities for the product
Understand overall market, an environment surrounded the product and customer insights to develop robust launch strategy.
Develop tactics based on analysis obtained from data, facts, and insights, and lead commercial activities by leveraging omni-channels
Implement launch activities by leveraging internal resources and partnerships with third-party vendors, industry organizations, and, if required, other pharmaceutical companies
Keep eyes open for new information regarding company products, competitors, local and global markets, latest discussions among KOLs and academia, and legislation in Japan
Lead discussions among global/regional/local colleagues to create launch strategies for product and ensure all the cross-functional colleagues pursue the same goal
Develop revenue forecasts for the product in consistency with global and regional teams for strategies, assumptions, and models
Oversee promotional content development and marketing activities for HCPs and consumers, make sure those activities are executed in a compliant manner
Manage marketing budget and ensure related spends are completed within budget and on time.
Work with team members through coaching and mentoring;Provide the guidance and coaching to brand managers and other members in the TA as necessary to ensure their success as well as self-growth.
Create a culture and workplace environment that fosters enthusiasm, collaboration and engagements with peers and team members.
Uphold and adhere to company policies, compliance rules/regulations, SOPs, and pharmaceutical regulatory guidelines (i.e. cGMP/cGLP/cGCP).
Yui Osone
Pharma -
Job number: Job-00265760 Posted: 2024-04-23
CMC薬事
充実したパイプラインの大手外資系製薬メーカー5.5 - 10 million yen Kansai Pharmaceutical Regulatory Affairs
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- 開発段階から市販後まで、CMC関連の薬事業務全般
臨床試験段階（CTN/CIB、機構相談（品質）資料の作成等）
医薬品承認申請（CMC申請戦略の策定、CTD／承認申請書の作成・照査）
医療機器承認・認証申請（CMC申請戦略の策定、STED／承認申請書の作成・照査）
製造業許可・外国製造業者認定対応、GMP調査の当局対応窓口
市販後のメンテナンス
Yui Osone
Pharma -
Job number: Job-00253973 Posted: 2024-04-22
CMC薬事担当（ワクチン・細胞治療・バイオ）
細胞治療・再生医療等製品における何れかの薬事関連業務の経験を３年程度お持ちの方必見です。6 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is Global Leading Pharmaceutical Company.
- Responsibilities
- バイオ医薬品、ワクチンや細胞治療・再生医療等製品の開発段階から承認取得に関するCMC薬事戦略立案、資料作成、当局対応等の業務全般を担当する。
Patrick Chang
Pharma -
Job number: Job-00229475 Posted: 2024-04-22
CMC薬事シニアマネージャー
医薬品業界における経験をお持ちの方必見です6.5 - 9.6 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a global pharmaceutical company with its own distribution channels around the world.
- Responsibilities
- グローバルの薬事部門、製薬技術部門及びその他の関連部門と連携し、グローバルに新薬開発段階から承認申請及び承認後製品の変更管理に関わるCMC薬事業務全般を担当いただきます。薬事申請のためのCMC薬事戦略の策定
申請資料（CMC部分）作成における関連部門との調整及び資料のレビュー
申請資料（CMC部分）の記載内容に関する関連部門との協議及び調整
グローバルのCMC承認情報の管理
CMC薬事関連の照会事項、その他の問題に対する対応
承認申請～市販後変更に関わる薬事要件の収集、格納及び情報共有
Martin Tsvetkov
Pharma -
Job number: Job-00231411 Posted: 2024-04-22
【品川】グローバルCMC薬事担当 ※グローバルリーダー候補として活躍できる
海外での勤務経験、もしくは留学経験ある方歓迎です6 - 10 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is Global Leading Pharmaceutical Company.
- Responsibilities
- 有望な研究開発プロジェクトを多数抱える当社において、グローバルCMC薬事の業務をお任せします。
■業務内容：
医薬品の開発段階から承認取得に関するCMC薬事戦略立案、資料作成、当局対応、等の業務全般を担当する。
■キャリアパス：
・CMC薬事を担当する組織に所属し、CMC申請戦略の策定／推進あるいは申請書作成の業務を通じ、CMC薬事を担うグローバルリーダー候補として活躍する。
・自身の強みや適性を見据えて、CMC研究の品質設計、研究開発本部あるいは信頼性保証本部、海外グループ会社などの薬事部門で活躍の場を広げ、経験／専門性／人脈を活かして会社業績に貢献することを期待する。
Patrick Chang
Pharma -
Job number: Job-00227050 Posted: 2024-04-22
【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
- Our client is a major Japanese pharmaceutical company.
- 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。
Patrick Chang
Pharma -
Job number: Job-00212962 Posted: 2024-04-22
[Tokyo/Shizuoka/Ibaraki] QA for Drug Development and New Product Launch
Rich Pipeline and Global Culture7 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a global pharmaceutical company with its own distribution channels around the world.
- Responsibilities
- Contribute to development projects by ensuring the quality of investigational drugs used in clinical trials conducted globally and complying with regulations such as GMP.
Promotion of quality assurance operations such as management of investigational drugs, investigational drug substances and new product manufacturing contractors, change management in the development phase, implementation of quality audits, shipment of investigational drugs by appropriate product quality management, etc.
Building and collaborating with joint development partners
Improvement of global quality assurance system for developed products, continuous improvement, promotion of new regulation compliance
Promote regulatory inspection response and inspection preparation in cooperation with related departments such as laboratories, manufacturing contractors, and supply chains so that early application and launch of new products can meet and respond to regulatory requirements globally.
Participate in the global working team within Quality Assurance and Quality Technology to solve quality assurance issues and improve and improve the quality assurance system.
Initial development phase Quality assurance work at product manufacturing plants such as regenerative medicine
Martin Tsvetkov
Pharma -
Job number: Job-00257456 Posted: 2024-04-22
CMC薬事ノンラインマネージャー
国際的な業務経験がある方歓迎8 - 11.5 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a global pharmaceutical company.
- Responsibilities
- 仕事の基本的な目的：RRL JP CMCのマネージャーは、LRLとして担当製品/プロジェクトの薬事戦略を策定し、実施する責任を有し、以下を含む活動を行う： Regulatory Excellence Teamの重要なメンバーであり、GRLのCMC関連事項の窓口となり、担当する開発プロジェクトおよび日本向け上市品について、タイムリーな申請・承認を可能にする強固な薬事戦略の提供および現地薬事活動の調整に貢献する。
開発品（PMDA申請中のものを含む）、上市品、グローバルRA、その他CMC関連事項（マスターファイルを含む）の製品およびプロジェクトに関連する薬事活動について、日本の規制当局とのインターフェースおよびコンタクトパートナー。
日本におけるCMCに関する規制要件の専門家。特定のプロジェクトや活動に関してCMC RA責任者をサポートする。担当プロジェクト／製品、登録申請、薬事コンプライアンスに関するLRLおよび／またはGRLのコンタクトポイントとして活動し、保健当局およびBIから信頼されるパートナーとなる。
■責任：1. 薬事戦略および登録活動薬事エクセレンスチームの不可欠なメンバーであり、CMCおよび薬事コンプライアンス関連事項に関するGRLの窓口であり、担当する開発プロジェクトおよび日本向け上市製品について、タイムリーな申請・承認を可能にするため、強固な薬事戦略の提供および現地薬事活動の調整に貢献する。レギュラトリー・エクセレンス・チームのミーティングやディスカッションに積極的に参加し、日本の薬事に関するアドバイスや最新情報をGRLに提供する。薬事ステータスアップデートの作成、マネジメントブリーフィング（製品アップデートレポート）、プレリード、薬事専門家グループ（REG）でのプレゼンテーションなど、GRLを現地面でサポートする。
日本のCMC規制に関するインプットとガイダンスを提供し、現地の要求事項と合意された戦略が、可能であれば迅速な規制パスウェイを含む申請において確実に対処されるようにする。
製品ライフサイクルにおけるCMC規制上の潜在的課題を特定し、調査し、解決策を提案する。"
Patrick Chang
Pharma -
Job number: Job-00211292 Posted: 2024-04-22
品質保証 QA
Global Company6 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a biopharmaceutical company.
- 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
Patrick Chang
Pharma -
Job number: Job-00207780 Posted: 2024-04-22
[Ascent] CMC RA
CMC RA8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
- Responsibilities
- Prepare documentation (including for Cartagena Type 1 Applications and CMC Consultations) with team under direction of scientific/ management lead
Interact and manage project communications with clients in bilingual environment
Support interaction with regulatory authorities
Patrick Chang
Pharma -
Job number: Job-00237087 Posted: 2024-04-22
東京◇CMC薬事（ギャップ分析・承認申請業務など）
薬事申請業務経験者歓迎です!6 - 8 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a pioneer and leading CRO contract research organization.
- Responsibilities
- 低分子及びバイオ医薬品のCMC薬事に関連した業務をお任せいたします。
日本の規制要件への対応状況の確認（ギャップ分析）
CTD（CMCパート）作成
承認申請書の作成
申請後の照会事項回答
現在はリモート中心でお打ち合わせやミーティングを行うことが多いです。もちろん必要に応じて出社いただいても問題ございません。
プロジェクトは知識やご経験に応じて希望をお伺いし、アサインいたします。1プロジェクトあたりの人数は1～3名で行っております。
Patrick Chang
Pharma -
Job number: Job-00265047 Posted: 2024-04-22
Health Outcomes/Real World Evidence Scientist
Opportunity to join global pharma with strong pipeline7 - 15 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- The purpose of the Research Scientist, Japan Value, Evidence and Outcomes (Japan VEO) is to deliver valuable evidence that addresses health outcomes issues, maximizes product value in the portfolio, and contributes to improvement of people’s health by demonstrating scientific leadership in evidence strategy development, planning, HEOR/RWE study development and execution.
Primary Responsibilities:
Strategy
Develops and oversees local HEOR/RWE strategy for compounds in the portfolio in Japan in the relevant therapeutic area(s) that is aligned with local product strategy and global/regional HEOR/RWE strategy.
Drives sustained integration of HEOR/RWE from early clinical development through commercialization depending on focus of the assigned project or therapeutic area.
Formulates and drives Patient Focused Outcome, Real World Evidence, and/or economic value strategies for priority products.
Provides strategic direction to address complex health outcomes challenges.
Study Development and Execution
Leads local HEOR/RWE evidence planning and execution for individual compounds/products across the development and commercialization lifecycle to support drug development, optimize pricing and access, and maximize post-launch product value in collaboration with local cross functional team and/or global VEO/VEO International.
Develops and designs HEOR/RWE studies that can address important gaps for the products, is scientifically robust and feasible, and meet relevant quality standards.
Applies technical expertise appropriate for the role (e.g., scope or depth in statistical analysis, economic modeling, clinical trials, PFO development, observational/ epidemiologic research methodologies) within a therapeutic area.
Ensure sustainable delivery of planned evidence in a timely manner.
Organizational Leadership and Influence
Demonstrate scientific leadership in evidence strategy, planning, study development and execution. Links technical expertise with business acumen and establishes and maintains strategic relationships with key internal and external decision makers.
Effectively integrates with and influences key business partners and external stakeholders to achieve goals and outcomes
Promote strategic integration into global for both projects and functional activities.
Can apply unprecedented innovative approaches with taking a risk to deliver best results.
Information Dissemination
Effectively communicates HO information to internal business partners, the scientific community, and customers.
Drives research dissemination strategies and leads research communication efforts including abstracts, posters, podium presentations, promotional materials, and manuscripts.
Plan for, align, and drive application of results/ deliverables to increase the impact of HO work
Actively participates in shared learning opportunities to effectively share knowledge and experience (both positive and negative) of management tools and other learnings with colleagues and peers, locally and internationally.
Environmental Awareness
Maintains awareness of significant developments in disease states in the portfolio and HO field including current HO methodologies and applications, availability in various real world data, relevant regulations, and other issues as appropriate for the position.
Anticipates and evaluates future market needs and trends for HO information within pertinent therapeutic area and geography of interest.
Monitors and influences internal and external environmental factors that shape and impact generation and use of HEOR/RWE research.
Maintains a presence and relationship with the research community related to the relevant areas.
Project Management
Partner with Project Managers in Japan VEO to ensures projects meet timelines, budget, and scope by coordinating research efforts with cross-functional team and external collaborators as appropriate.
Yui Osone
Pharma -
Job number: Job-00266232 Posted: 2024-04-20
薬理研究員
大学院修士課程修了後、博士課程入学後あるいは6年制大学卒業後5年以上の生物学研究経験をお持ちの方必見です。9.73 - 11.63 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- Our client is one of the leading pharmaceutical companies in Japan.
- Responsibilities
- 大規模疾患ゲノム情報やリアルワールドデータ（RWD）などのデータからの疾患関連遺伝子、バイオマーカー、薬剤作用機序同定など創薬研究におけるデータ解析の活用
アンメットメディカルニーズを捉えた新規薬剤候補の提案（プロジェクト創出）・およびその創薬研究推進
薬効評価系の構築
Patrick Chang
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 -
Job number: Job-00267191 Posted: 2024-04-19
Director: RWE Partnerships & Innovation
Director position at global mega pharma16 - 30 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- The RWE Partnerships and Platforms organization functions to:Enhance company's ability to determine unmet medical needs;
Support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE);
Inform clinical practice on appropriate prescription and use of company products;
In collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers;
Support measurement of short- and long-term impact of company products to both patients and populations;
Support competitive differentiation.
This position will serve as the Real World Data point of contact for either one category or one geographic region.Execute on prioritized tactical plans with actionable projects, identify external partners to deliver strategic RWE capabilities / data, and oversight of high quality methods and designs to inform study / project designs for R&D franchise / asset teams, CMAO, Health Economics and Outcomes Research, Commercial and other functions’ needs
Provide daily mentorship, motivation, and guidance to more junior RWE colleagues, & direct them to co-develop emerging, core a strategic partnerships with commercial and academic data suppliers
Supports landscape assessments, new data / tool / partner due diligence assessments based on understanding evolving healthcare, technology and other industries with Customers, RWE Digital platform team, Digital RWD Enterprise Enabling Platform, RWE Biostatistics and other relevant partners
Documents all requests and track progress toward project completion, other metrics and business goals
Develops training materials for ensuring colleagues understanding and competency in various aspects of the RWE process
Communicates critical knowledge on business processes to relevant stakeholders
Yui Osone
Pharma -
Job number: Job-00267502 Posted: 2024-04-19
MSL
製薬企業において、がん領域におけるMSL経験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 global pharmaceutical company.
- Responsibilities
- 治験施設選定のサポートおよび治験責任/参加医師とのエンゲージメントの実行及びその記録
顧客からの要望に応じた早期開発品に関する科学的情報の提供
行動規範・法令の順守
Patrick Chang
Pharma -
Job number: Job-00261383 Posted: 2024-04-19
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 CRO5 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- 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.
- 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
Yui Osone
Pharma -
Job number: Job-00218125 Posted: 2024-04-18
Hematology MSL
Hematology MSL7 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is developing and providing various medicines for an array of health concerns.
- Responsibilities
- 血液疾患領域において自社のメディカルポジション(世評、信用)の確立。
自社製品並びに関連疾患領域に関する最新の医学・医科学情報を提供。
HCPから依頼があった場合に限り、未承認薬・適応外薬等に関する情報を提供。
メディカルアフェアーズプランで言及されるメディカル戦略に従い活動。
メディカルアフェアーズの疾患領域チームで合意したKOLリストを基に個々のKOLに対し計画を立て活動。
HCPとのコミュニケーションを通じてメディカルニーズの収集と評価を行い、インサイトの探索ならびにメディカルアフェアーズプランの策定および更新に貢献。
企業主導型臨床研究の実施支援、および医師主導型臨床研究関する助言・支援。
メディカルエデュケーションプログラムおよびアドバイザリーボードの実施支援。
医薬情報担当者への研修の支援。
Patrick Chang
Pharma