製薬 の求人情報一覧
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求人番号：Job-00222648 掲載日：2023-07-03
Business Planning Manager,
Sales planning8000 - 12000 万円 東京 製薬 営業 / MR
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- Market analysis and strategy development:
Japan strategy development, annual plan and 5 years plan
Market assessment by applications, in close collaboration withrelevant stakeholders
New market/application trends analysis
Commercial Execution initiatives:
Performance management (KPIs monitoring)
Sales channel management(including e-commerce, digital, data analytics)
Drive project implementation and executions of selected initiatives across PS Japan organizations
Commercial Operations:
Direct responsibility for meeting/activities objectives and agendas
Support sales data and information analysis
Collaborate with controller for financial analysis/KPIs for
Martin Tsvetkov
Pharma -
NEW求人番号：Job-00267191 掲載日：2024-04-19
Director: RWE Partnerships & Innovation
Director position at global mega pharma1600 - 3000 万円 東京 製薬 マーケットアクセス / プライシング / HEOR
- 会社概要
- 同社は医療用医薬品を研究・開発・製造・販売しています。
- 業務内容
- 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 -
求人番号：Job-00232759 掲載日：2023-06-15
【神奈川／東京】グローバル開発薬事
5年以上のR＆Dにおける薬事経験が活かせます。1500 - 1800 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、再生医療の研究開発を行っています。
- 業務内容
- 心筋細胞、膵島細胞の両開発資産に対するグローバル規制戦略の策定をリードする
ビジネスユニットヘッドをサポートし、グローバルの申請データパッケージの設計を行う
FDAなど海外の規制当局と協議する際のリエゾンとして、IND申請に必要なCMCデータパッケージや前臨床データパッケージの適切性、薬事申請をサポートする試験デザインなど、あらゆるトピックについて責任を担う
Presidentと直接連携し、投資家、株主、キーオピニオンリーダー、メディアなど、グローバルな主要ステークホルダーとの間で加速の可能性を含むあらゆる規制関連事項を提示し、議論する
会社のビジョン・ミッション・目的を達成するために、全社的なタスクをリード・参加する
Patrick Chang
Pharma -
求人番号：Job-00259434 掲載日：2024-01-18
海外薬事開発アソシエイトディレクター
研究開発薬事経験が活かせます。1500 - 1500 万円 東京 製薬 マーケティング
- 会社概要
- 同社は、再生医療の研究開発を行っています。
- 業務内容
- 心筋細胞および膵島細胞の両開発資産に関するグローバル規制戦略の策定を主導
BUヘッドをサポートし、グローバルに申請データパッケージをデザインする
FDAなど海外の規制当局と協議する際に、CMCデータパッケージやIND申請のための前臨床データパッケージの適切性、規制当局の主張をサポートするための試験デザインなど、あらゆるトピックについて責任ある橋渡しとなる。
投資家、株主、キーオピニオンリーダー、メディアなど、グローバルな主要ステークホルダーとの加速の可能性を含む規制関連事項のプレゼン、ディスカッションを社長と直接連携して行う
会社のビジョン、ミッション、目的を達成するために、全社的なタスクをリードする
Patrick Chang
Pharma -
求人番号：Job-00203428 掲載日：2023-06-15
Medical Manager
Strategy planning and data gathering1300 - 1700 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- STRATEGY:
Act as Local Medical Affairs TA expert in one or more TAs
Support the Brand or launch teams/ Local TA leadership team in the development of TA, Launch and Brand strategies
Lead Medical Affairs activities in assigned territory along defined local Medical Launch / Brand strategies
Consolidate and communicate trends, market insights, and unmet needs identified in the field
OPERATIONS:
Develop Medical material, review marketing material, trainings
Ensure scientific and clinical accuracy for specific product or brand
Receives adverse event reports and transmits such reports internally according to Company procedures
Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations
Maintains up-to-date GxP knowledge by following internal and external trainings
Conduct Local internal scientific training and ensure continuous Medical education of existing teams and new employees working in the Local TA
Develop Medical KTL development plans
Positively impact external perceptions and knowledge regarding company and company products
Maintain and demonstrate comprehensive and in-depth scientific TA knowledge when executing assigned tactics
Ensure operational excellence by sharing best practices
Map treatment landscape and medical environment for new indications/ programs
Provide support in the planning and tracking of the (TA-specific) medical budget
DATA GENERATION AND DISSEMINATION:
Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects
Lead Local publication process, publication dissemination and alignment with Local, Regional and Global publication plan
Act as a resource, liaison and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy
Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites
Assimilate, process and share medical information with stakeholders
STAKEHOLDER ENGAGEMENT:
Provide training to HCPs and support in realising Medical educational events
Interact with Local stakeholders in Medical community in TA
Identify and interact with influential members of the Medical community (HCPs/external experts) and other healthcare stakeholders (managed care organisations, government organisations, patient groups) within assigned territory and TA
Represent company at Medical Education events, programs, meetings and support patient advocacy related activities
Partner with external stakeholders to develop innovative solutions
Engage with internal colleagues (Medical Affairs department, Clinical Operations, Commercial colleagues as appropriate, etc.) in developing and delivering and participating in Medical or cross-functional initiatives
Martin Tsvetkov
Pharma -
求人番号：Job-00266089 掲載日：2024-03-28
Pricing & External Affairs Senior Manager
Pricing Senior Manager position at global mega pharma1200 - 1800 万円 東京 製薬 マーケットアクセス / プライシング / HEOR
- 会社概要
- 同社は医療用医薬品を研究・開発・製造・販売しています。
- 業務内容
- ResponsibilitiesDevelop strategic NHI pricing strategies and gain endorsement of NHI pricing strategies and proposals of NHI prices with Country President and TA Leads through the Pricing Committee
Develop robust pricing dossiers and strategically manage price negotiations
Build strong alignment & partnership among Japan Pricing Core members (New Asset & Access Strategy team, New Asset Analysis team, DJ, Medical, Launch Excellence Team, Policy and Public Affairs, and the global PHI) to ensure optimal price setting
Develop Pricing-related OP assumptions
Refresh pricing assumptions and estimated prices for pipeline products and BD assets to reflect the latest competitive environment
Minimize the downward price adjustment by price revision/repricing through cross-functional collaboration
Maintain good relationship with “Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, MHLW” (former EAD) and act as a mediator between the company and MHLW to flawlessly manage all product-related issues, as well as NHI pricing negotiation
Actively participate in trade association activities (FPMAJ, PhRMA, FIRM, etc.) to establish a pro-innovative pricing framework
Contribute to building a high performing team by actively engaging in coaching junior colleagues and nurturing a positive environment where people feel energized and eager to speak up
Yui Osone
Pharma -
求人番号：Job-00266093 掲載日：2024-04-09
Specialty Care Medical Affairs Lead
Medical Affairs Lead position at global mega-pharma1200 - 2200 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は医療用医薬品を研究・開発・製造・販売しています。
- 業務内容
- 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 -
NEW求人番号：Job-00266963 掲載日：2024-04-22
Senior Brand Marketing Manager
Senior Brand Manager at global mega pharma1200 - 1700 万円 東京 製薬 マーケティング
- 会社概要
- 同社は医療用医薬品を研究・開発・製造・販売しています。
- 業務内容
- 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 -
NEW求人番号：Job-00267071 掲載日：2024-04-19
Quality Assurance Senior Manager
Full Remote QA Senior Manager position1200 - 1500 万円 東京 製薬 品質保証 / 品質管理
- 会社概要
- 同社は外資系製薬会社です。
- 業務内容
- 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 -
求人番号：Job-00208873 掲載日：2024-04-13
Digital Marketing Project Manager
Digital PM1200 - 1600 万円 東京 製薬 マーケティング
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- 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 -
求人番号：Job-00266278 掲載日：2024-04-04
【東京／本社】安全対策・メディカルドクター職（メディカルレビュアー）
がん領域の診療経験ある方歓迎1200 - 1600 万円 東京 製薬 医師
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- 業務内容：
抗がん剤などの治験品もしくは市販品の安全性業務を担当副作用・有害事象症例の個別の安全性評価（メディカルレビュー）
個別症例評価に関するグローバルでの検討、基準の確立（日本のメディカルレビュアーの代表として、個別症例に関する海外MDとのディスカッションリードを含む）
治験品および市販品の安全性に関する従業員への教育
重大な副作用発生時における使用医師等との専門性に基づく円滑なコミュニケーション
■キャリアパス：まず、医師としてのキャリアを活かした個別症例の安全性評価業務を経験させる。
海外の安全性部門、グローバルCROとの会議等を通し、グローバルでの安全性評価の全体像を理解させる。
その後、本人の特性や希望に応じて、安全対策に関する業務の経験や将来的には安全管理部門の責任ある立場も考慮する。
Patrick Chang
Pharma -
求人番号：Job-00211156 掲載日：2023-06-15
Senior Manager Clinical Research
Global position1200 - 1800 万円 東京 製薬 臨床開発
- 会社概要
- 同社はアメリカを拠点とする親会社を持つ大手ライフサイエンス企業です。主に医薬品やワクチンの研究開発、輸入、製造、販売を事業として展開しています。人々の健康を守り、豊かな人生を築く手助けをすることで、同社の使命・目標に向かって日々奮闘しています。
- 業務内容
- Create Japan clinical development plan within global development strategy
Lead clinical studies in Japan from scientific perspective
Lead PMDA consultation related to Japan clinical development
Develop clinical study protocols
Support development of other study-related materials (e.g. draft Informed Consent, Case Report Form, study related SOP, etc.)
Support study operations
Perform medical monitoring of clinical study data
Develop Clinical Study Reports
Lead clinical related part of approval review
Develop clinical sections of the Common Technical Document (CTD)
Develop responses for clinical related inquiries
Make presentations at scientific meetings and/or author manuscripts on clinical trials, or provide necessary support for them
Martin Tsvetkov
Pharma -
求人番号：Job-00203644 掲載日：2023-10-04
Medical Doctor - Safety
1st MD position in the company1200 - 1800 万円 東京 製薬 ファーマコビジランス
- 会社概要
- 同社は、ビジネスの変革や顧客エンゲージメントの強化など、デジタル経済での成長を促進するためのさまざまなソリューションを提供しているグローバルなIT企業です
- 業務内容
- Perform second level triage workflow, review through the entire source document for any potential serious adverse event/s in the case based on conventions
If the case is serious, then in the activities tab, select the Case level seriousness as Yes
After the review of the case, document the assessment in the same action item, To be retained as Non-serious OR To be upgraded as Serious with respective rationale and close the action item
Inform the respective triage associate via email for upgraded case
Ensuring the ICSR is medically relevant, complete and accurate
Validation of Seriousness criteria, events captured, coding, labeling, Causality assessment, Writing Company / PV comment. Review and finalize Narratives.
Generating medically relevant follow-up questions
Identifying and notifying potential signals
Martin Tsvetkov
Pharma -
求人番号：Job-00204324 掲載日：2024-03-08
【東京】Head of Genito-Urinary Marketing
オンコロジー・マーケティング経験者必見です!1200 - 1800 万円 東京 製薬 マーケティング
- 会社概要
- 同社は、ヨーロッパに本社を置く国際的な薬事関係企業です。
- 業務内容
- 長期、中期、短期の事業戦略とマーケティングプランを策定し、GUエリアにおける同社製品の販売ポテンシャルを最大化する。
市場調査能力を確立し、実行することで、市場領域を定義し、ターゲットとなる医師や医療機関を選定して市場領域の定義、ターゲットとなる医師・医療機関の選定、市場ポテンシャルの推定、競合他社の分析、医療・治療ニーズの現状と将来をビジネスに反映させるための現在および将来の医療および治療上の要求をGU製品のビジネスに反映させる。
短期的な全国レベルのマーケティングプランを実現し、効果的な広報活動と広報・情報施策（会議、ミーティング、販促資料など）を用いた短期的な全国レベルのマーケティングプランを実現する。メディカルアフェアーズ/マーケットアクセスと協力して、タイムリーかつ利用可能な方法で提供する。
研究開発およびグローバルオンコロジーチームと協力して、収益と利益の最大化を実現するために、GU製品のライフサイクルマネジメントを計画、実施する。R&Dおよびグローバルオンコロジーチームと協力して、収益と利益の最大化を実現するために、GU製品のライフサイクルマネジメントを計画・実施する。
Martin Tsvetkov
Pharma -
求人番号：Job-00203537 掲載日：2023-11-29
MD
2nd in MD to be hired in JP1200 - 1500 万円 東京 製薬 医師
- 会社概要
- 同社は医薬品、医療機器の開発を行っています。
- 業務内容
- Collaborate with Cross functional members to contribute to the development of products desired in the medical field and to maximize of product value.
Participate in discussions on optimizing our technology with algorithms.
Understanding of our treatments through discussions with KOLs at our target hospitals.
Support sales from science perspective as the core of medical communication that emphasizes compliance.
Join the discussion with KOLs for proper use of Illuminox to meet “Unmet Needs” in cancer treatment.
Conduct a wide range of medical / science activities such as doctor-led clinical trials, publications, and advisory board meetings.
Evaluation and support of clinical trials, presentations at academic conferences on clinical trials, publications, promotional materials, web contents, information on briefing sessions, etc. Manage operational aspects of clinical trials from study start-up through database lock as assigned, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements.
Martin Tsvetkov
Pharma -
求人番号：Job-00203429 掲載日：2023-06-15
Clinical Trial Leader
Managing all clinical activities1200 - 1700 万円 東京 製薬 臨床開発
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
Accountable for oversight of CROs in the execution of Phase I – III global clinical trial(s).
Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
Accountable for the successful preparation and presentation of operational content at key governance discussions
Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team
Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
Accountable for partnering with CRO in audit responses and addressing quality issues.
Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
Ensures strong inspection readiness application for all assigned clinical trials.
Manages a small project or project stream with tasks of low to moderate complexity within a larger project. Leads a small project team with members typically from direct working environment and a straightforward project structure. Coordinates stakeholders from own area or even closely related areas or is partially or even fully responsible for the project’s management within small to medium sized projects. Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
Accountable for projects within a clearly defined scope and milestones. Receives moderate to low level guidance and direction within broad guidelines.
Martin Tsvetkov
Pharma -
求人番号：Job-00203430 掲載日：2023-10-11
Senior Manager, Regulatory Manager
Managing two different teams1200 - 1700 万円 東京 製薬 薬事
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- Effective manage regulatory pathway for Life Science (LS) products and services in Japan, cover the areas of biopharma processing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, equipment/instrument, biologics and animal derived materials, etc.
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
Drive, manage and coordinate registration / notification / listing activities in Japan. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
Provide regulatory guidance in risk assessment, identify regulatory impact to the Life Science and provide regulatory recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.
Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.
Martin Tsvetkov
Pharma -
求人番号：Job-00203431 掲載日：2023-07-03
Senior Clinical PMS Manager
In charge of all clinical PMS1200 - 1700 万円 東京 製薬 臨床開発
- 会社概要
- 外資系医薬品会社です。
- 業務内容
- Accountable for day to day activities of all aspects of the operational management of local post-marketing studies (PMCT and PMS), including study timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
Accountable for the oversight of investigator-initiated studies granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
Develop and monitor study budget and timelines
Monitor work to ensure quality
Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
Contribute to the planning and set-up of a study and provide planning parameters
Overseeing external providers, Act as an interface between Global Clinical Operations and local organizations (Global Operations)
Martin Tsvetkov
Pharma -
求人番号：Job-00261920 掲載日：2024-01-18
安全対策・メディカルドクター
癌領域の専門性や経験をお持ちの方必見です。1200 - 1600 万円 東京 製薬 医師
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- 抗がん剤の開発プロジェクトへの参画もしくは上市後間もない抗がん剤を担当し、以下の安全対策業務に従事する。
副作用・有害事象症例の安全性評価と臨床試験における安全対策の検討
RMP（医薬品リスク管理計画）等の安全対策の立案・実施
安全対策に関する当局との交渉（承認申請時の対応含む）
重大な副作用発生時におけるKOL（Key Opinion Leader）や使用医師等との専門性に基づく円滑なコミュニケーション
治験時のベネフィットとリスクバランスの評価および安全確保措置の立案・推進
医療機関からの問い合わせに対する対応
Patrick Chang
Pharma -
求人番号：Job-00259606 掲載日：2023-12-01
グループマネージャー
製薬・バイオテクノロジー企業におけるバイオ医薬品で少なくとも1年以上のCMC経験をお持ちの方必見です。1100 - 1400 万円 Kanagawa 製薬 研究＆開発
- 会社概要
- 同社は、再生医療の研究開発を行っています。
- 業務内容
- iPS細胞由来細胞製品の製造プロセス開発（製法改良、スケールアップ、工業化）戦略の策定
iPS細胞由来細胞製品の製剤設計及び臨床試験サイトへの輸送戦略の策定
CMOへの製造移管業務のリード及びGMP製造の管理業務
規制当局とのCMCに係る面談等の準備及びそのリード
治験申請資料作成等のCMC関連文書作成業務
製造グループメンバーの業務及び勤務管理
Patrick Chang
Pharma