Jobs list of Pharmaceutical
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NEWJob 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 -
NEWJob 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 -
NEWJob 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 -
NEWJob 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 -
NEWJob number: Job-00267421 Posted: 2024-04-18
プロダクトマーケティング＜ストーマケア製品＞
週3出社でOK／充実した研修制度で業界未経験でも安心／社会貢献度も高い／業界経験不問／リモート有6 - 8.5 million yen Tokyo Pharmaceutical Marketing
- Company overview
- Our client is an American headquartered company based in the U.S. They specialized in ostomy, continence, wound and critical care products.
- Responsibilities
- ■概要：ストーマ保有者様のお肌の健康を第一に考えた製品の開発と製造を行うブランドのプロダクトマーケティングマネージャーをお任せします。
■業務詳細：顧客ニーズの把握・分析
マーケット・競合動向の把握
マーケティング戦略の立案
資材作成及びイベントの企画運営
■当ポジションの魅力：排泄という患者様の尊厳を守れるプロダクトを扱うため、社会貢献度高く働くことができるポジションです。患者様の声からも、ダイレクトに大きなやりがいを感じることができます。
Risa Harada
Medical Device -
NEWJob 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 -
NEWJob number: Job-00222653 Posted: 2024-04-16
Head of Electronics Business Development Asia
M&A10 - 20 million yen Tokyo Pharmaceutical Sales / MR
- Company overview
- This company is one of the world’s leading pharmaceutical companies.
- Responsibilities
- You will have the key role to drive the identification and execution of growth opportunities in Asia: You will investigate the financial performance as well as the product portfolio and capabilities to assess the attractiveness and fit with our strategy.
You will work closely in a cross functional team with the Business Fields, the Heads of Business Development, Strategy and Portfolio within the Electronics Strategy and Transformation unit as well as supporting functions to select the most attractive opportunities.
Based on your strong interpersonal and negotiation skills and your existing network you will build strong relationships to the management of target companies and drive the execution with Group M&A.
Martin Tsvetkov
Pharma -
Job number: Job-00208873 Posted: 2024-04-13
Digital Marketing Project Manager
Digital PM12 - 16 million yen Tokyo Pharmaceutical Marketing
- Company overview
- This company is one of the world’s leading pharmaceutical companies.
- Responsibilities
- Manage eCommerce and/ or other digital projects
Lead and manage related projects. Interact with internal and overseas stakeholders.
Plan eCommerce and Digital strategies
Support Head of eCommerce & Digital to devise eCommerce and Digital strategies. Discuss with internal (domestic/ overseas) stakeholders, promote initiatives, and concretize initiative details and ROI.
Responsible for leading/ managing related projects. Interact with internal and overseas stakeholders.
Martin Tsvetkov
Pharma -
Job number: Job-00267036 Posted: 2024-04-11
メディカルサイエンス職
研究およびメディカル活動を計画、実行する経験が活かせます。10 - 13 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is a biopharmaceutical company.
- Responsibilities
- 領域における最新情報やアンメットメディカルニーズ等の情報を収集・分析することで、メディカルギャップを特定し、患者さんに貢献するためのメディカル戦略を計画、実行する。
Patrick Chang
Pharma -
Job number: Job-00209392 Posted: 2024-04-11
【品川】研究職（オンコロジー領域 薬理研究者）
「がん領域」重点領域としています！6 - 12 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- Our client is Global Leading Pharmaceutical Company.
- Responsibilities
- がん研究ポートフォリオ構築、テーマ立案、評価系構築
化合物・抗体等評価など
Patrick Chang
Pharma -
Job number: Job-00266803 Posted: 2024-04-11
品質保証 次世代ポテンシャル採用
大手外資系ファーマでの次世代ポテンシャル採用6 - 9.5 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- Overall Job Purpose:
西神製造所における医薬品／医療機器製造工程、製品試験に関する製品品質保証業務
Job Responsibilities:
新製品導入に伴うGMP対応、品質保証システムの構築、社内関係部門との調整（社内の国内、海外関連部門と協働し、GQP, GMPに基づく製造所としての品質基準、保証システムを構築）
国内販売製品の製造所としての品質管理（製造および試験記録照査、逸脱、変更、バリデーション管理）
品質情報及び品質不良等としての調査、報告業務
製造所における監査対応業務、出荷判定業務
社内の海外製造所との品質改善活動
Yui Osone
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-00211678 Posted: 2024-04-10
[Janssen] Contract & Compliance Services, Site Engagement Analyst
Open to CRO CRA Candidates6 - 9 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is developing and providing various medicines for an array of health concerns.
- 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
Patrick Chang
Pharma -
Job number: Job-00266093 Posted: 2024-04-09
Specialty Care Medical Affairs Lead
Medical Affairs Lead position at global mega-pharma12 - 22 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- Leadership of medical team, including setting business objectives, performance management and team development
Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas
Recruitment, development and retention of talented colleagues as well as coaching and guidance of colleagues to support them achieving their maximal potential
Membership of Medical and Commercial Leadership Teams
Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs
Ensure compliance of medical team with country Code of Practice and relevant SOPs, regulations and guidelines
Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications
Work with key external stakeholders during the life-cycle of the company's medicines, supporting the company strategy and bringing external insights to the organization to shape strategy and providing focused, relevant information in response to their needs
Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs
Ensure that product materials and related activities reflect the most up to date regulatory labelling and risk management plans and regulatory commitments
Input into regulatory submissions, clinical overviews, license variations and CDS updates as required
Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required
Input into assessment and due diligence of business development initiatives
Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio
Support for in country clinical research programs, including protocol and site feasibilities related to portfolio
Protocol approval and oversight of in country non-interventional studies related to portfolio
Support for investigator initiated research (IIR) studies to ensure that appropriate records are kept and progress is monitored
Support for media, government and patient group activities, including policy development, corporate initiatives and issues management
Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered
Accountable for medical team IIR and headcount/expenses budgets
Represent the country and countries interests to European and Global teams
Yui Osone
Pharma -
Job number: Job-00266804 Posted: 2024-04-09
品質システム コンプライアンス
大手外資系Qualityポジション6 - 9.5 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- 文書管理システムの運用及び管理
文書管理責任者（又は文書管理担当者）
文書及び記録の保管と管理（GMP Library、GQP/QMS Archive
GMP/QMS/GQP/GDP 上の基本的な文書（GMP/QMS/GQP 総則、手順書類）の維持
手順書類の制定及びメンテナンス、及びこれらに関する他部署へのサポート
署名の管理
トレーニングシステムの運用教育訓練責任者（又は教育訓練担当者）
年間教育訓練計画の作成、実施及び/又はサポート
トレーニングカリキュラムの維持
各業務エリアにおける認定の実施と維持
文書・教育に関連する 社内スタンダード 、Global Quality Standards (GQS) のギャップアセスメント及び対策検討
文書管理システム、及びトレーニングシステムをサポートするためのコンピュータシステム の運用管理Success Factors のデータ管理
文書管理システムの運用・管理、及び適正な運用のための指導（文書管理システム 管理責任者/文書管理システムワークフロー管理者）
社内ののデータ・サイト管理
QSC 内でのトレーニング＆文書管理関連業務が円滑に行えるよう、担当者の管理を行う。
Yui Osone
Pharma -
Job number: Job-00241499 Posted: 2024-04-08
【東京】医薬品の臨床開発におけるデータマネジャー
データベース構築／運用に関する知識をお持ちの方必見です!6 - 11 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a biopharmaceutical company.
- Responsibilities
- 当社が主導する臨床試験・臨床研究における国内外データマネジメントCROのオーバーサイト
効率的なCROオーバーサイト手法の検討
ウェラブルデバイス、eCOA（electronic Clinical Outcome Assessment）など多様なデータの最適なハンドリングプロセスの策定（使用デバイスの選定への参画含む）
DDC（Direct Data Capturing）など効率的なデータ収集方法を活用した臨床試験・臨床研究のデータマネジメントプロセス策定
データエンジニアリング：データ二次利用のためのデータ基盤へのデータ格納／払出し、新規データ種の格納プロセス策定
Shotaro Tsubaki
Medical Device -
Job number: Job-00210480 Posted: 2024-04-08
[Osaka or Tokyo] Clinical Team Manager
Strong Global Foot Print and High Salary9 - 15 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
- 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
Patrick Chang
Pharma -
Job number: Job-00264497 Posted: 2024-04-05
コンタクトレンズマーケティングGマネージャー／管理職
日用消費財またはヘルスケア領域でのマーケティング業務経験をお持ちの方へ10 - 14 million yen Tokyo Pharmaceutical Marketing
- Company overview
- Our client is the global leader in eye care.
- Responsibilities
- ■業務概要：コンタクトレンズのマーケティンググループマネージャー業務をお任せいたします。
■業務詳細：今後3～5年の戦略プラン及び年間のマーケティングプランの策定
新製品イニシアチブを通じたカテゴリーポートフォリオの確立と強化
課題特定するための状況分析や結果に応じたマーケティング戦略の立案・実施し、チームを指揮・監督
海外マーケティングチームと協力し、日本のビジネスニーズに合ったブランド活動を構築・展開
売上管理・需要予測・効果測定・戦略策定・実装
主要なマーケティング戦略のPDCAプロセス管理
直属のマーケティング人材の開発・育成
■働く環境：週4日出社／週1日在宅勤務
中途入社者が多数活躍しており、かつ長期間勤務の方多数
■企業の魅力：外資系企業でありながら離職率は5％以下、人材育成には非常に力を入れております。
経営陣が各事業所に訪問して課題回収と改善協議を行うなど事業の透明性が高く、社員のエンゲージメントも高いです。
Linh Do
Medical Device -
Job number: Job-00210481 Posted: 2024-04-05
[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation
Rewarding Career, Global Development9 - 14 million yen Other Pharmaceutical Clinical Development
- Company overview
- In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
- 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
Patrick Chang
Pharma -
Job number: Job-00266168 Posted: 2024-04-05
品質管理 (製品品質試験)
Quality position at mega pharma with strong pipeline6 - 9.5 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- 注射剤及び固形製剤の品質管理、分析試験業務（理化学試験、微生物試験）、製品規格試験の実施及びそれに関わるverification
品質管理に係る手順、記録等の作成及び照査
逸脱・トラブルに対する調査及び問題解決策の提案・実施
変更管理
新製品導入に伴う試験法技術移管（海外本社・海外製造所と協働して実施）
部内における業務品質及び生産性改善活動
グローバル・ローカルプロジェクトのリード・参画
その他試験実施に関わる管理業務
Yui Osone
Pharma