年収1,800万円以上/医薬品の求人・転職情報
110件中の1〜50件を表示
外資系ヘルスケア業界
・担当領域の売上予測および売上計画主導
・予算策定、ローリングフォーキャスト、中長期計画の策定
・定期的な売上実績レポートを作成・管理
・予算・予測差異分析
・マネージャー:業界経験不問
・シニアマネージャー:ヘルスケア業界経験必須
東京都
1,600 万円 ~ 非公開
メルクバイオファーマ株式会社
・At least 3 years of experience in the pharmaceutical or related industry, with exposure to quality assurance, manufacturing, distribution, warehouse operations or related activities.
・Practical experience with good manufacturing practice, good distribution practice and good quality practice in Japan, together with experience in quality assurance systems.
・Working knowledge of Japan’s regulatory framework, including the Pharmaceutical and Medical Device Act, and experience supporting health authority inspections.
・Experience managing quality processes such as change controls, deviations, technical complaints, product recalls or withdrawals, quality risk management and corrective and preventive actions.
・Ability to analyze complex operational issues, prioritize work and make sound decisions with substantial professional responsibility.
・Strong collaboration, negotiation and influencing skills to work effectively with local, global and external stakeholders.
・Willingness to travel nationally and internationally; basic project management experience and familiarity with standard office applications are beneficial.
東京都
1,148 万円 ~ 2,025 万円
大手メーカー
•Assess compliance communications and training needs for the affiliate to effectively support ethics and compliance program needs and organizational change management goals and objectives.
•Conduct regular E&C risk assessment of affiliate practices and work with leaders to put in place appropriate responsive actions.
•Design and execute monitoring plans for the affiliate to address identified and prioritized risk areas.
•Consult on investigations with ethics and compliance implications and always collaborate with HR on speak up and investigations.
•Drive application of effective corrective and preventive action plans responsive to monitoring and investigation findings.
•Deliver meaningful insight to affiliate leadership derived from monitoring and other activities.
•Represent Japan externally with industry Ethics and Compliance peer groups, the industry association, and regulators, not only to understand the external environment but to influence and shape it, including by promoting high ethical standards across the pharmaceutical industry.
•Provide input into development of corporate compliance policies and procedures that reflect the needs of the affiliate. Work with leaders in the affiliate to develop and implement localized procedures. Ensure that these local procedures are consistent with global or business unit policies and procedures (or that any necessary exceptions are in place) and that they are effectively communicated to all impacted employees in the affiliate.
•Leverage AI, automation, and data analytics to generate valuable insights that catch risks early and prevent risks within areas of responsibility.
■Business Influence and Cross Function Collaboration
・Through deep business acumen and effective influence across different layers of the organization/leadership, ensure business discussions and decisions encompass and consistently take into consideration appropriate ethics and compliance elements, and that there is clear business ownership of ethics in all decisions taken.Influence leadership and business practices through effective communication of internal policies/standards and external environment risks.
•Ensure an open and collaborative environment that promotes teamwork, open
communication, and collaborative interactions to foster a culture of integrity.
•Orchestrate support from areas in Global Ethics and Compliance and other assurance functions.
•Collaborate with and influence Alliance Partner(s) to ensure high performance with high integrity in alliance settings in close partnership with business. Lead the compliance review and compliance agreement development for new business development deals.
・At least 3 years of experience within the pharmaceutical or related healthcare industry with knowledge of local laws, regulations, guidance and Codes.
・ Solid leadership experience
・Cross functional experience, experience to manage alliance situations preferred.
・Professional level proficiency in Japanese (speak, read and write) – preferably at the level to operate effectively with industry associations and regulators in Japan.
・Professional level proficiency in English to effectively collaborate with international E&C colleagues.
・ Bachelor's degree
【Additional Preferences】
・Demonstrated ability to consistently apply good judgement to enable quality business decisions.
・Ability to influence without authority and drive change across all layers of the organization.
・Strong strategic and critical thinking, with the ability to operationalize strategy and translate ambiguity and complexity into meaningful action.
・High proficiency in AI, automation, and data analytics, with the ability to analyze and visualize data for effective communication.
・Finance background preferred, with the ability to interpret financial data and follow financial flows.
・Strong business knowledge and results orientation.
兵庫県
972 万円 ~ 非公開
エランコジャパン株式会社
動物病院を広域展開する企業本部との戦略的関係の構築・強化
全国の企業病院のマネジメント
製品の導入企業とのコミュニケーションおよび施策サポート
能力開発
企業動物病院本部へ様々な分野の製品を持つ組織の特長を生かし、その病院のニーズに合致した製品使用の提案し、本部担当者の信頼を獲得しながら製品の売上を最大化できる。
企業動物病院の獣医師またはスタッフに適切なビジネス提案および情報提供を行い信頼獲得することで、良好な関係を築き同時に自社製品の売上を最大化できる。
動物薬卸店の営業担当者と密接なコミュニケーションにより卸店から最大限の協力を得る。
Required Experience: (mandatory for hiring)
小動物薬営業経験者(2年以上)
様々な製品分野での販売経験
Desirable Experience:
複数のエリアでの担当経験
Essential Skills / license: (mandatory for hiring)
自動車普通免許
高いコミュニケーションスキル
東京都
500 万円 ~ 非公開
セバ・ジャパン株式会社
動物用医薬品メーカー、飼料メーカー等における養豚向けテクニカルサービス・技術営業の経験5年以上
養豚農場の飼養管理や疾病対策に関する知識
【歓迎要件】
資格:獣医師資格、HACCP・JGAP審査員資格
養豚農場での勤務経験
神奈川県
700 万円 ~ 非公開
グラクソ・スミスクライン株式会社
Act as the primary Compliance business partner and advisor to assigned Business Units and promoted brands, providing real-time, risk-informed guidance that enables faster launch, campaign and HCP-engagement decisions.
Embed Compliance early into brand strategy, business planning, speaker programs and promotional/information-provision activities, framing risk at the point of decision rather than after the fact.
Interpret and translate MHLW Guidelines, PMD Act advertising requirements, JPMA standards and GSK written standards into clear, practical business solutions and “how-to-comply” advice.
Partner with BU Heads, Marketing, Sales and Medical to evaluate risk appetite, identify proactive and pragmatic mitigations, and support well-documented, defensible business decisions.
Own and drive the local Risk Management & Compliance Board (RMCB) agenda for assigned areas, ensuring visibility, escalation and remediation of significant compliance risks to the Head of Japan Compliance and JLT.
Design, embed and continuously improve the Internal Control Framework for assigned BUs, emphasizing prevention — early-warning indicators, controls and capability-building over detection alone.
Lead root-cause analysis and CAPA for compliance issues in the business, ensuring accountable owners, due dates, evidence-based closure and effectiveness checks that withstand inspection.
Deliver targeted training, coaching and communications on the GSK Code of Conduct and key risks, building compliance capability and confident decision-making within the business.
Foster high ethical standards, Speak Up culture; promote transparency and psychological safety so employees raise concerns early, and handle sensitive matters with appropriate confidentiality.
Partner with Independent Business Monitoring, the Supervisory Division, Legal, HR and Investigations to align monitoring insights, feed lessons learned back into the business.
Breadth/ Scope of Accountability:
Japan-wide advisory accountability for assigned Business Units and promoted brands across the end-to-end commercial and information-provision lifecycle.
Works across Commercial, Medical, Material Excellence, Legal, HR, the Speaker Program CoE and enabling functions, while preserving Compliance’s independent challenge role.
Advises and influences without direct commercial ownership; business and functional leaders retain accountability for their activities, risks and controls.
Accountable for the quality, timeliness and defensibility of Compliance advice, RMCB inputs and CAPA discipline for the assigned portfolio.
Trusted with highly confidential and sensitive matters; expected to escalate significant risk without delay.
*Future scope of job and working location will be determined by company.
A. Educational Background
Minimum Level of Education: Bachelor’s degree or equivalent practical experience
Area of Specialization: Law, Compliance, Life Sciences, Pharmacy, Business, Risk Management, or related discipline
Why is this level required: The role must interpret complex requirements, advise senior business leaders and translate regulation into practical, risk-based decisions.
Preferred Level of Education: Postgraduate qualification or relevant professional certification
Preferred Area of Specialization: Compliance, Legal, Regulatory, Business Administration, or Risk Management
Why preferred: Additional depth supports strategic business partnering, independent challenge and senior-level influence.
B. Job-Related Experience
Typically 8 or more years of relevant experience in pharmaceutical/healthcare compliance, ethics, legal, regulatory or risk management, including a track record of value-added business partnering. Equivalent depth may be considered.
Demonstrated ability to advise and influence senior commercial and medical leaders, balancing enablement of business performance with independent challenge.
Practical experience embedding internal control frameworks, running RMCB/governance processes and driving evidence-based CAPA and remediation.
People-management or team-leadership experience preferred; experience operating in a highly matrixed, multicultural organisation across geographies.
C. Other Job-Related Skills/ Background
Strong working knowledge of Japan pharmaceutical compliance expectations — MHLW Guideline for Product Information Provision Activities, PMD Act advertising requirements, JPMA standards and applicable GSK written standards.
Excellent business acumen and the ability to differentiate significant from less-significant risks and offer pragmatic, proactive mitigations.
Clear written and verbal communication in Japanese (native level) and English (business level); able to influence, coach and facilitate cross-functional discussions.
Strong problem-solving and conflict-management skills, learning agility, and the ability to maintain confidentiality, trust and independence.
Comfort with data, monitoring analytics and the responsible use of approved AI/digital tools to anticipate and prevent risk.
High integrity, sound judgement, courage to escalate, and a preventive mindset focused on effective controls rather than administrative burden.
*Legal right to work in Japan.
東京都
1,000 万円 ~ 1,800 万円
外資製薬企業
The Japan Vaccine Medical Team is a high-performing team of medical leaders who are a trusted source of Scientific and Medical information and shared insights; effective and innovative strategic partners to our internal and external stakeholders; and dedicated to public health. We represent diverse experiences and backgrounds which strengthens our team and mirrors the healthcare communities we engage.
Main Responsibilities
The Japan vaccines Franchise Medical Manager will participate to and execute the Medical and scientific (non-promotional) strategy for the Influenza & Covid Vaccines portfolio/therapeutic area in close partnership with the other functional franchise leads and in alignment with the overall franchise strategy.
The Main Responsibilities Include
Utilize strong business acumen, acting as a key strategic business partner to the organization
Initiate and drive projects to raise standards of care and change clinical practice
Ability to work independently with a solutions-oriented and balanced approach to ambiguity
Lead and drive rapid integrated evidence planning and execution through deep understanding of internal and external stakeholder evidence needs and robust data gaps analysis
Deep therapy area expertise and product knowledge including competitor data
Drive strong collaborative relationships with commercial and cross-functional teams, including marketing, value & access, health economics, regulatory and clinical
Cultivate and maintain relationships with external experts
Drive collaborative relationships with above-country colleagues to ensure the MCO / country involvement and strategic input into global and regional plans
Good understanding of the impact and evolution of healthcare systems
Lead creation and implementation of medical plans
Ability to rapidly assimilate new data and integrate into new therapy area
Create industry leading digital educational and scientific content that is timely, relevant, interactive and innovative
Champion the patient voice when developing and implementing medical strategies
Demonstrate strong leadership influencing across networks and by coaching and mentoring members of the team
About you
Doctorate level education: MD or equivalent medical degree preferred, PhD or PharmD
Industry experience (including medical affairs field or office) and/or clinical experience mandatory, ideally with relevant immunology, vaccinology, epidemiology, public health or internal medicine focus on acute medicine/ICU experience.
Good understanding of the continuum of data generation including clinical development, Real World Evidence (RWE) and data gaps analysis
Excellent communication skills including driving challenging discussions· Develop a good understanding of HCP communication preferences to adapt communication style and optimize use of relevant channels to suit
Implement true scientific engagement journeys by bridging channel disconnect to drive ongoing engagement and grow collaborative opportunities and meaningful scientific exchange
Be confident in the use of Omnichannel tools and ability to adapt to new channels
Effectively and compliantly share unmet needs of HCPs and their centers with cross-functional teams to inform patient centric strategy
東京都
1,400 万円 ~ 1,850 万円
外資製薬企業
The Respiratory and Rhinology Medical Head drives clarity and accountability of the entire Japan medical functions and cross-functional team members, to achieve the business objectives through the development and execution of medical strategies.
Reporting to the Japan Head of Specialty Care Medical, and involved in development of the strategic medical plan, the Respiratory and Rhinology Medical Head ensures the execution of key deliverable, conducts timely analyses, and provides updates, utilizing clear and consistent communication.
The role leads the teams to improve operations effectiveness and to execute key projects, while serving as the medical point of contact for alliances.
【Key Responsibility】
Develop Respiratory and Rhinology therapeutic area plans for Alliance immunology products:
Oversee the development of medical strategies and timelines for key product-specific cross-functional projects (eg Product Ad Boards, LCM activities related to Phase IV, and Investigator initiated studies and other cross functional initiatives led by Medical)
Provide input during the development of global product plans regarding publications, training initiatives, KOL planning and metrics, etc
Collaborate with regional medical contacts to align on the global plan and exchange information on global/local medical activities, strategies and tactics
Work with the team to identify risks to the programs and develop mitigation steps for them
Communicate appropriate and timely program information to key functions:
Work with the team to identify risks to the programs and develop mitigation steps for them
Execute Respiratory and Rhinology MedicaI Therapeutic Area Plans:
Lead strategic financial trajectory, Annual 0perating Planning activities as well as forecast resources in conjunction with Global Medical Director, global medical functions and Commercial partners, for proposed tactics, research initiatives, publications, advisory boards, medical training, medical information, and personnel, etc
Lead Local Respiratory and Rhinology medical team and related meetings by proactively identifying agenda items, assimilating appropriate meeting content, facilitating alignment, and ensuring appropriate follow-through
Partner with global medical functional leads regarding functional product plans to ensure product- team alignment and timely execution
Drive and implement best practices through the creation of processes, tools and templates (ie Product team list with roles and responsibilities, product resources list, etc)
Plan and track key milestones and report progress of Medical plans
Facilitate prioritization of activities within Medical plans
Provide input into infrastructure improvement initiatives (eg. Operational, technical etc)
Serve as contact for worldwide affiliate regarding meeting content development for the product
Supervise and coach MSL managers towards the identification, mapping and quarterly review of KOLs to develop and maintain customized engagement plans,
Monitor and supervise MSL Managers’ execution of plans with their respective teams and with prioritized KOLs via regular coaching sessions
Manage and meet reporting requirements of MSL performance including supervising the MSL managers monitoring metrics towards set KPIs ensuring excellence in execution of their role towards achieving strategic and tactical goats.
MD in Internal medicine and/or advanced degree (PhD) in life sciences preferred
Strong verbal and written communication skills in both English and Japanese.
Minimum of 5 years of related industry experience
Prior experience conducting strategic planning activities, leading cross-functional teams at different levels, as well as a solid understanding of a Global Medical Affairs and R&D environment and pharmaceutical commercialization and regulatory processes are highly preferred
Able to operate independently (with minimal supervision) and navigate complex regulatory environments in person and via digital channels from remote (non-office based) environment.
Possible substantial travel: nationally and internationally
Ensures regulatory boundaries re non-promotional activities are respected vis-a-vis commercial partners.
Key skills:
Ability to cultivate solid internal and external network
Excellent interpersonal skills/highly collaborative
Strong facilitative leadership skills: ability to drive consensus across diverse functional groups
Excellent analytical and problem- solving skills
Strong financial and operational skills: project/timeline management
Sound scientific/technical and business acumen
External consultant and vendor management
東京都
1,870 万円 ~ 非公開
日本イーライリリー株式会社
Partner with cross-functional teams and global stakeholders to identify, assess, and mitigate compliance risks, while embedding ethical decision-making and a strong culture of accountability across the organization.
Play a key role in supporting new business initiatives, digital innovation, and strategic partnerships by providing compliance leadership, influencing critical decisions, and driving organizational change and capability development.
Bachelor’s degree or higher.
Minimum of 5 years’ experience within the pharmaceutical, biotechnology, healthcare, or related industry.
Working knowledge of applicable healthcare laws, regulations, industry codes, and compliance requirements.
Strong cross-functional collaboration experience, with the ability to partner effectively across business functions and stakeholder groups.
Professional-level fluency in Japanese and business proficiency in English, with the ability to operate effectively in a global environment.
Demonstrated integrity, sound judgment, and a strong commitment to ethical business practices.
■Preferred Qualifications
Experience in Compliance, Legal, Risk Management, Internal Audit, or other governance-related functions.
Leadership experience within commercial, sales, or business operations organizations.
Experience supporting alliance partnerships, brand teams, or new business initiatives.
Proven ability to influence senior stakeholders and drive decisions without direct authority.
Strong strategic thinking, problem-solving, and change management capabilities.
Ability to translate complex and ambiguous situations into clear, actionable business solutions.
Strong business acumen with an enterprise-wide perspective.
Inclusive leadership style with a passion for coaching, mentoring, and developing talent.
High level of professional maturity, discretion, and confidentiality.
JD, CPA, or equivalent professional qualification is a plus.
兵庫県
972 万円 ~ 非公開
グローバル製薬企業
グローバルに事業を展開する製薬・ヘルスケア関連企業において、APAC地域(主に日本・オーストラリア)を担当するコンプライアンスマネージャーポジションです。
グローバルコンプライアンス部門に所属し、日本法人の経営陣とも連携しながら、APAC地域におけるコンプライアンスプログラムの運営・推進を担当いただきます。日常的なビジネス支援に加え、医療従事者(HCP)対応に関する審査・承認、ポリシー整備、教育研修、内部調査、リスク評価およびモニタリング活動など、幅広い業務を担います。
営業、メディカル、法務、薬事、内部監査などの関連部署や海外チームと連携しながら、コンプライアンス体制の強化と企業倫理文化の浸透を推進していただくポジションです。
【主な業務内容】
■コンプライアンス業務全般
・医療従事者との契約・講演依頼・学会協賛等のレビューおよび承認
・経営層向けのコンプライアンス関連レポート作成
・グローバルコンプライアンスチームとの定例ミーティングへの参加
・APAC地域における法規制や業界動向のモニタリングおよびリスク分析
・海外拠点経営陣との定期的なコミュニケーション
・贈収賄防止・腐敗防止に関する第三者デューデリジェンスの実施
■メディカル・コマーシャル領域のコンプライアンス支援
・MR・MSLによる情報提供活動に関するアドバイス
・販促資材、メディカル資材、講演会資料等のコンプライアンスレビュー
・外部モニタリングに関する委員会対応および関連資料作成
■ポリシー整備・教育研修
・APAC地域のコンプライアンス関連規程やガイドラインの整備・改訂
・社内からの問い合わせ対応
・年間コンプライアンストレーニング計画の策定
・教育研修および社内啓発施策の企画・運営
・新入社員研修や営業・代理店向け研修の実施
・コンプライアンス関連資料や教育コンテンツのローカライズ支援
■調査・リスクマネジメント
・内部通報案件やコンプライアンス事案の調査対応
・関係者ヒアリング、調査報告書作成、是正措置の推進
・人事部門と連携した再発防止策や指導対応
・監査・モニタリング活動を活用したリスク低減施策の推進
■コンプライアンス監査・モニタリング
・APAC地域におけるコンプライアンスリスクアセスメントの実施
・年間監査・モニタリング計画の策定および実行
・講演会、販促活動、営業同行、各種記録類のモニタリング
・グローバル本社への定期レポーティング
・モニタリング結果を踏まえた業務改善・プロセス改善の推進
【ポジションの特徴】
・APAC地域を担当するリージョナルポジション
・日本・海外双方のステークホルダーと連携するグローバルな環境
・HCP対応、販促審査、教育研修、内部調査、監査・モニタリングまで幅広いコンプライアンス業務に関与可能
・経営層や海外本社との接点が多く、事業に近い立場でコンプライアンス推進を担えるポジション
・製薬・ヘルスケア業界における高度なコンプライアンス経験を積むことができる環境
• In-depth knowledge of the industry’s standards and regulations related to compliance with healthcare laws
• Able to work independently and know when to appropriately escalate an issue for resolution
• Capacity of problem solving - anticipating, initiating and resolving issues
• Demonstrated ability to communicate effectively with individuals up, down, and across the organization
• Excellent technical and communication skills
• Fluent in Japanese and English
東京都
715 万円 ~ 1,872 万円
日本ベーリンガーインゲルハイム株式会社
The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader.
The Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually at Start of Development through Phase I–III.
The Clinical Program Leader provides medical/scientific, technical, and managerial direction to plans, programs, and procedures within project and indication areas to effectively develop new compounds and/or optimize the profile of existing compounds.
The Clinical Program Leader in Experimental Medicine Japan assumes responsibility for engaging External Experts (EEs) in Japan. A core element of this role is identifying and engaging experts with expertise in:
・Early clinical development
・Translational science
・Advanced modalities within the therapeutic area
and leveraging their scientific and operational insights to inform global early clinical development strategy.
■Accountabilities
Clinical Development Leadership
Represents the specific Therapeutic Area on International Multidisciplinary Core Teams and takes clinical development responsibility for assigned projects, including:
・Definition of Target Product Profiles (TPP)
・Clinical Development Plans (CDP)
・Pediatric Investigational Plans (PIP)
・Core Clinical Trial Protocols
・Input to Project Analysis and Data Management Plans
・Investigator's Brochure
・Medical input to Company Core Data Sheet
・Annual Safety Reports / IND Safety Reports
・Preparation for key milestones:
・Start of Development
・Proof of Clinical Principle (PoCP)
・Release of Full Development
■Related Performance Indicators
・Provides medical oversight throughout protocol development, study conduct, analysis, and reporting.
・Responsible for continuous benefit-risk assessment.
・Provides medical leadership during regulatory meetings.
・Contributes to submission strategy and regulatory filings.
・Addresses safety issues.
・Oversees medical project budgets.
■Cross-Functional Team Leadership
Serves as Chairperson of the Global Early Clinical Development (ECD) Team and/or Medical Sub-Team (MST), depending on project stage.
Responsibilities include:
Proposing team members together with the (Associate) Therapeutic Area Head.
Representing ECD/MST on:
・Core Team
・Therapeutic Area Leadership Committee (TALC)
・Clinical Expert Committee (CEC)
・Human Pharma Steering Committee (HPSC)
Additional activities:
・Oversees interactions with:
External experts
Advisory boards
Adjudication committees
Safety Data Monitoring Boards
・Reviews and approves publications related to the project in collaboration with the Medical Head.
・Identifies studies that should be conducted.
・Provides input into Medical Affairs strategic documents, including:
Scientific Platform
Publication Plan
Product Maintenance and Optimization Summary
■Key Accountabilities of the Clinical Program Leader in Experimental Medicine Japan
■External Expert Engagement
・Map and prioritize External Experts (EEs) in the region, including:
Indication experts
Translational clinicians
Phase II trialists
・Build and maintain relationships to obtain scientific input and support trial success.
・Facilitate scientific discussions to ensure regional expertise contributes to:
Emerging science and innovation relevant to TA Inflammation
Proof-of-Concept (PoC) study design, including endpoint selection
Biomarker strategy
■Regulatory and Organizational Requirements
Operates within the requirements of global Standard Operating Procedures (SOPs) and working instructions.
■Job Complexity
Complex due to:
・Global nature of the role
・Matrix organization
・Direct multidisciplinary interaction
■Interfaces
Works with:
・Global matrix teams
・Regional BI counterparts
・External partners
Academic institutions
Investigators
■Also interfaces with:
・Regulatory authorities
・International societies
・Other relevant international stakeholders
Preferred:
PhD or MD
Specialist in a specific Therapeutic Area or equivalent expertise
■Job Impact
Responsible for the project's medical budget.
■Minimum Education / Degree Requirements
Preferred:
PhD or MD
Board certification in a specific Therapeutic Area or equivalent clinical experience
■Required Capabilities (Skills, Experience, Competencies)
PhD or MD preferred (specialist in a Therapeutic Area or equivalent) with strong clinical expertise.
Up to 3 years of pharmaceutical industry experience preferred.
Successful track record in planning, conducting, and publishing basic science and/or clinical research.
Strong medical and scientific leadership ability to drive high-priority projects across global matrix teams, regional BI counterparts, and external partners.
Ability to act with composure and resilience under pressure.
Strong project management skills.
Experience interacting with regulatory authorities, international societies, and other key stakeholders.
Strong communication and presentation skills.
Excellent cross-functional collaboration skills and ability to work effectively in virtual teams.
Ability to establish strong partnerships with top external experts, national/international societies, and other stakeholders.
Ability to engage in advanced scientific knowledge exchange.
Fluency in both Japanese and English.
東京都
1,000 万円 ~ 1,800 万円
シミックCMO株式会社
シミックCMO株式会社では医薬品の受託製造を行っております。
医薬品の安定供給を行う工場を最前線で支え、工場と一緒に成長してみませんか。
【足利工場 魅力】
・既存の注射剤に加え、2018年に新注射製剤棟を設立し、注射剤製造を行うマザー工場となっています。
・固形製剤、注射剤全般の製造を担っており、ほぼ全ての剤形に関わることが可能です。
・新棟は国内CDMOの中でも設備は最高級レベルを誇ります。
・複数社から受託⇒各社の情報集積⇒高い技術を集約・技術力UP⇒信頼獲得⇒業績UPの好循環が生まれています。
・従業員の駐車スペースも十分に確保していますので、お車での通勤も快適です。
【求人 魅力】
・リーダーシップ研修やビジネススキルに関する教育も充実しており、マネジメント職へのキャリアアップにも挑戦いただけます。
【業務詳細】
注射剤・固形剤の製剤製造に関する業務をご担当頂きます。
社内外関係者と協力し、GMP業務の経験を生かして、製造オペレーションの業務・メンバーをリードしていただきます。
<オペレーション業務例>
・注射剤原材料の秤量・調製作業
・使用資材の洗浄・滅菌作業
・注射剤の充てん作業
・各種製造設備のオペレーター業務(打錠機・コーティング機等)
・製造支援設備(製薬用水・空調)の日常点検 等
・医薬品製造業務経験
【歓迎要件】
・注射剤製造業務経験
栃木県
500 万円 ~ 非公開
ブリストル・マイヤーズ スクイブ株式会社
The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.
Duties/Responsibilities
Medical Monitoring
Conducts medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
Japan CTP could be expected to take a primary CTP role for local initiated trials or program
Clinical Development Expertise & Strategy
In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
Provides oversight and medical accountability for a group of studies
Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Health Authority Interactions & Publications
Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist
Ability to deliver the outcomes under the ambiguity or complexity
Ability to partner with people at all levels of the organization
Ability for proactive proposal building and proactive action takings without detailed instructions
Ability to respond flexibly to the changing project/task priorities and work assignments.
Ability to influence and negotiate without specific authority.
Ability to take a risk and to manage it without jeopardizing quality and/or compliance
Ability to build action plans based on the organization vision
Acts to makes a balance between short-term performance and long-term vision.
Fluent in spoken and written English & Japanese for business is preferred
東京都
800 万円 ~ 1,800 万円
The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.
The clinician may be required to design a development strategy for multiple protocols designed to obtain approval particularly in Japan and other countries in Asia for a compound or group of compounds
■Role Responsibilities
Protocol design and strategy:
Contributes towards the medical input during protocol development and updates to the clinical development plan.
Work closely with other clinicians and Japan study team members to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
Provides medical input into country feasibility.
Accountable for safety across the study:
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician may delegate these responsibilities to the study clinician scientist/Japan Clinical Lead identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.”
Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
Communicates safety information to sites across the study and provides responses to questions on safety.
Support study team:
With supervision of Global Development lead provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed
Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing.
Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
Provides protocol specific training to study team, investigators, clinical research associate, and others.
Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
Interacts with DMCs and steering committees as required.
Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
Monitor investigator compliance with protocol and regulatory requirements.
Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team:
Works closely with Japan development teams providing medical input and knowledge throughout the program from inception through completion and regulatory approval.
Under supervision (director/Sr director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report, clinical overview for JNDA submissions).
May co-author abstracts, posters, presentations and publications.
May contribute budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators:
May support Clinical Regulatory Authority interactions, particularly with the PMDA, accountable for providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.
Medical degree (M.D)
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/house officer" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
Possesses the ability to critically evaluate medical/scientific information.
Excellent written and oral communication in English and Japanese.
Understands the design, development, and execution of clinical programs and studies.
Capacity to adapt to a fast paced and changing environment
■Preferred/Nice to have:
Documented work experience/knowledge of statistics
Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
Experience with investigational clinical trials is preferred.
Flexibility to join frequent late night/early morning teleconferences with international study teams.
Ability to travel domestically or internationally occasionally as required.
東京都
1,200 万円 ~ 1,800 万円
ロシュ・ダイアグノスティックス株式会社
・製品戦略の立案と実行(Go-To-Market戦略)
・日本市場における質量分析装置および関連する免疫ソリューションの導入・発売戦略、ターゲットセグメンテーション、価格戦略の策定
・製品ライフサイクル(導入から安定稼働、生産終了・終売まで)を通じたプロダクトケアと収益性の最適化
・クロスファンクショナルな連携と課題解決
・国内のアプリケーション・技術サポートの総責任者として、難度の高い問い合わせや苦情のセカンド・サードライン対応において、数名の専門エンジニア、サイエンティストをリード
・担当製品群の日本の代表者として、日本の顧客の声(VOC)を集約し、グローバルの開発・マーケティングチームへプロダクト改善の提案・交渉
・社内外への技術・価値の伝承(イネーブルメント)
・海外(グローバル)での製品・技術トレーニングを受講し、日本国内のフィールドサイエンティストや営業員向けへのローカライズされたトレーニング計画の立案と実行
・マニュアル、顧客案内、学術・販促用技術文書の作成および監修(英語から日本語への翻訳・ローカライズを含む)
・収益・コストマネジメント
・適切な製品マネジメント(在庫管理連携、保守パーツ・サポートコストの最適化など)を行い、コスト抑制と安定稼働に貢献
【期待する役割】
・グローバルとローカルの架け橋:グローバル組織と対等にコミュニケーションを図り、日本市場の要求仕様を通すと同時に、国内社員への適切な教育と支援を行い、製品ライフサイクルマネジメント業務を牽引する。
・サポート・エスカレーション体制の早期確立:国内のアプリケーションサポート最終責任者として、困難なトラブルシューティングの仕組み化を行い、グローバルと連携した迅速な解決体制を構築する。
・ビジネスへの貢献:サイエンティストとしての知見をバックボーンに持ちながらも、コスト抑制、クロスセル・アップセルの機会創出など、経営視点を持って製品をマネジメントする。(質量分析だけでなく、免疫をはじめとした他領域とのシナジーを見据えた戦略的アプローチを含む)
・ヘルスケア業界(医療機器、IVD、ライフサイエンス、製薬等)における事業戦略・プロダクトマーケティング戦略の策定から実行、P&L管理(あるいは数値目標のコミットメント)に携わった実務経験
・市場トレンド・競合環境・顧客ニーズ(KOL/医師/臨床検査技師等)の分析に基づき、中長期の製品ロードマップやマーケティング戦略を描き、自導して成果を出した経験
・ビジネスレベルの英語力:海外本社・グローバルチームとの戦略的ディスカッション、英語でのプレゼンテーション、海外研修の受講、英文ドキュメント作成を問題なく行えるレベル(TOEIC 700点以上目安)
<優遇条件>
・MBA(経営学修士)の学位、または経営・マーケティング領域における専門教育の受講経験
・体外診断用医薬品(IVD)または高度管理医療機器の国内上市(薬事申請後のGTM計画、診療報酬・保険収載戦略、価格設定、プロモーション等)の一連のプロセスを主導した経験
・質量分析(LC-MS/MS等)関連業務の実務経験質量分析装置のプロダクトマネジメント、学術サポート、または開発・設計の経験
・医療機器・体外診断用医薬品(IVD)の日本国内への上市(ローンチ)サポート・マーケティング経験
■求める人物像
・オーナーシップと自律性:前例のない課題に対しても、自発的に情報を集め、仮説を立てて自走できる方
・ステークホルダーマネジメント:営業、サービスエンジニア、アプリケーション、そして海外グローバルチームと円滑な関係を築き、巻き込める高いコミュニケーション能力
・医療貢献へのマインドセット:自身の扱う質量分析テクノロジーを通じて、日本の医療および臨床検査全体の発展に貢献したいという強い熱意
・論理的思考力と交渉力:複雑な技術的・ビジネス的課題を論理的に整理し、グローバルや顧客に対して明確に説明・交渉できる能力
東京都
800 万円 ~ 非公開
大手外資製薬会社(バイオ領域)
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化
・製薬業界でのマーケティング経験(3年以上)
・マネジメント経験(2年以上)
・英語:中級 ビジネスレベル
東京都
1,300 万円 ~ 1,800 万円
■ミッション
優れた製品を一人でも多くの患者さんに届け、患者さんのためにサイエンスに再投資し続けられる製薬企業として競合優位性を維持し続けることに貢献する
■業務の範囲
・市場環境、顧客、製品及びポートフォリオを理解すると共に、ビジネス課題を特定・構造化・分析し、課題を解決するための製品戦略および中長期プランを策定
・市場調査の企画立案、調査結果に基づく外部要因・内部要因・Customer insight分析
・戦略に基づいたプロモーションアクティビティーの計画・実施・管理及び評価(資材・イベント・デジタル施策の計画・実行および評価など)
・マーケティング・営業活動を計測するためのシステム関連の提案、他部門と協業し社内システムを構築
・KEE (Key External Experts)マネジメントの遂行
・関連する社内(グローバルチーム含む)及び社外ステークホルダーとの連携及び協業
<必須 / Mandatory>
医薬品業界でのマーケティング経験3年以上、プランを一人で作成し実行した経験
<歓迎 / Nice to have>
Oncology領域でマーケティング経験のある方
【能力 / Skill-set】
<必須 / Mandatory>
・仮説に基づいて実施した市場調査の結果や客観的事実を正しく読み取りインサイトを抽出する課題を抽出する力。また、市場状況・市場動向をもとに仮説を構築する力
・客観的に事象を捉え正確に現状を分析し、理解できる能力(分析や調査業務の経験はプラスです)
・課題解決にむけてアクションが実行できる行動力
・医師との面会を通じて課題を同定できる質問力と分析力
・自らの得意分野に安住せずチャレンジし続ける姿勢・目的達成のために新たな取組やアプローチを試みる姿勢
・チームとして成果をだすための関係部門との協業の姿勢
・エクセル/パワーポイントによる資料作成能力・そのほか社内で使用されているITを活用できる
・ロジカルシンキング
・コミュニケーション能力
複数あり
1,100 万円 ~ 1,800 万円
アストラゼネカ株式会社
TADの監督下で、新製品または特定治療領域に関する製品戦略およびgo to market modelの策定。承認後は営業活動、および販売促進資料の開発を実施する。また、予算編成を支援する。営業チームと緊密に連携して、必要な資料を提供する 等
■マーケティング戦略策定 及び 営業戦略策定の立案・実行
- 市場環境、顧客、製品およびポートフォリオを深く理解し、ブランドチーム、関係部門と協力しながらビジネス課題を特定・構造化・分析し、課題を解決するための製品戦略を立案することに貢献する
- 市場環境の正確な理解、戦略立案のための仮説の検証、打ち手の評価を一次・二次調査により明確にし戦略の検証・改善を行うことに貢献する
- 競合に打ち勝つためのgo to market modelを立案し、実装する
■マーケティング戦略の実行
- 製品戦略に基づく実行プランを自らが中心となり立案・実行・評価まで責任を持って実施する
- 戦略の立案・実行に際して社内外のステークホルダーへ提案し、承認・サポートを獲得する
- 営業部門を始めとする他部門と密に連携をとり、マーケティングプランの伝達を行う
- KEEのマネジメントを円滑に行い、戦略の実行を徹底する
<必須 / Mandatory>
・医療用医薬品メーカーでのマーケティングのご経験3年以上
【能力 / Skill-set】
<必須 / Mandatory>
■求めるスキル・姿勢
・将来、ビジネスを牽引するリーダーに成長したいという志
・自らの得意分野に安住せず、チャレンジし続ける姿勢
・個人の能力だけではなくチームとして高い成果を出せる働き方
・現時点での業務で自らの成果として自信を持って説明できるものがある
・過程ではなく成果物の質にこだわる姿勢
・客観的に事実ベースで現象をとらえ、現状を正確に理解する能力
複数あり
1,100 万円 ~ 1,800 万円
アストラゼネカ株式会社
優れた製品戦略の立案と実行を通して製品およびポートフォリオのベネフィットを一人でも多くの患者さんに届け、AZのサイエンスの価値を最大化することで、患者さんのためにサイエンスに再投資し続けられる製薬企業として競合優位性を維持し続けることに貢献する
【業務の範囲】
・上市前製品の市場環境、顧客、製品およびポートフォリオを深く理解し、I&AやMedical teamなど関係部門と協力しながらビジネス課題を特定・構造化・分析し、課題を解決するためのブランド戦略を立案する
・上市戦略に基づく実行プランの一部(主にコンテンツ作成・イベントなど)を立案・実行・評価まで責任を持って実施する
・リサーチャーと共に、市場環境の正確な理解、戦略立案のための仮説の検証、打ち手の評価を一次・二次調査により明確にし戦略の検証・改善を行う
・戦略の立案・実行に際して社内外のステークホルダへ提案し、承認・サポートを獲得する
・営業部門を始めとする他部門とのコミュニケーション、社外医学専門家のマネジメントを円滑に行い、戦略の実行を徹底する・グローバルチームや他国と協力しながら日本に留まらない製品価値の最大化をサポートする
複数あり
1,100 万円 ~ 1,800 万円
大手外資製薬会社
複数あり
1,100 万円 ~ 1,800 万円
As the leader of Japan's Commercial Forecasting & Analytics department, this role is accountable for leading a team of forecasting, integrated demand planning and analytics professionals, shaping forecasting strategy, and providing executive leadership with robust forecasts, market insights and scenario-based recommendations that drive business decisions.
Working closely with Commercial, Finance, Medical, and Market Access, the role develops, challenges and refines commercial assumptions, translates market uncertainty into actionable business scenarios, and ensures alignment between commercial ambition, demand plans and operational feasibility.
Beyond delivering forecasts and demand plans, the role is responsible for building team capability, developing high-performing teams, and fostering a culture of data-driven decision-making, collaboration and continuous improvement.
■Why this role
This role offers a unique opportunity to operate across the full business value chain, from market opportunity and commercial strategy through demand planning and supply execution.
Unlike many forecasting roles that focus purely on statistical forecasting or demand planning, this role provides direct exposure to business decision-making and allows you to influence both commercial outcomes and operational execution.
You will:
· Influence business decisions across a diverse portfolio of innovative medicines and vaccines.
· Partner directly with Business Unit Heads, Finance leaders, and Supply Chain leadership.
· Lead a team that shapes business outcomes through forecasting, analytics, and business insight.
· Gain end-to-end visibility from market opportunity and sales forecasting through manufacturing and supply execution.
· Build forecasting approaches tailored to Japan's market realities rather than simply adopting global forecasting models.
· Develop a broad understanding of the business by working across multiple therapeutic areas, products and stages of the product lifecycle
■Key responsibilities
①Deliver forecasts and predictive analytics that enable better business decisions
· Lead Japan's commercial forecasting and demand planning process across the portfolio, including innovative medicines, vaccines, new launches and established products.
· Develop, challenge and refine commercial assumptions in partnership with Business unit leaders and Finance, and convert them into robust forecasts, business scenarios and strategic recommendations. Ensure that internal and external business drivers are appropriately reflected in forecasting assumptions.
· Analyze the variance between actual and forecast, and continuously fine-tune predictive models to maintain high accuracy
②Build and develop a high performing forecasting & analytics Team
· Provide strong people management for a professional team of data analysts, data scientists and business planners.
· Cultivate team capabilities, manage performance evaluations, and upgrade the team’s overall ability to translate complex data into actionable business stories.
③Lead integrated forecasting and demand planning
· Lead integrated demand planning by converting commercial forecasts and business scenarios into aligned demand plans that support business objectives while considering operational feasibility.
· Challenge unrealistic demand assumptions where necessary and support fact-based discussions to balance commercial ambition with supply feasibility, product availability and inventory risk.
④Represent Japan in Global planning process and ensure forecast accountability
· Own Japan's forecast submission process and ensure forecasts are submitted accurately and on time as part of the commercial planning cycle.
· Act as the key representative for Japan in regional demand discussion, providing clear explanations of forecast assumptions, business context, market dynamics, risks, and opportunities.
· Ensure Japan-specific market realities are appropriately reflected in enterprise planning and supply decisions
*Future scope of job and working location will be determined by company.
①Skill
・Agile and distributed decision-making under pressure and with incomplete information using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox.
・Building strong relationships with Commercial teams who hold final decision-making power, acting as collaborative strategic partner rather than an isolated data provider.
・Ability to lead cross-functional alignment and drive consensus across stakeholders with different priorities.
・Strong executive communication skills, with the ability to translate complex data and assumptions into clear business narratives and recommendations.
・Creating a performance culture and driving results, prioritization, execution, delivering performance.
②Experience
・10+ years of professional experience in Commercial (Sales/Marketing), Business analytics/intelligence or Business planning within Pharmaceutical (Rx/Ethical drug) or Fast-Moving Consumer goods industries.
・Hands-on experience in statistical modelling and simulation with multiple variables incorporating identification of key drivers, risks, financials and sensitivity analysis, using customer data, market data or prescription data.
・Experience supporting new product launches, lifecycle management, business planning or financial planning through forecasting and scenario analysis.
・Minimum 4 years of experience leading and managing a team of specialized professionals
③Education/Certification/Language
・University degree (Data Science, Computer Science, Statistics, Mathematics, Business, Economics, Finance) or practical experience in a relevant field
・Good written and verbal communications skills in English
Bilingual Japanese / English preferred.
■Preferred Qualification
・Experience in the Understanding of the pharmaceutical industry
・Experience leading commercial excellence
・Understanding of demand planning, S&OP / IBP, supply constraints, inventory management and product availability considerations.
・Conceptual understanding of advanced analytics, machine learning or statistical modelling techniques, with the ability to apply them to business decision-making rather than purely technical model development.
・Experience utilizing pharmaceutical/medical source (e.g. IQVIA, MDV/JMDC or primary marketing research data)
*Legal right to work in Japan.
Skills
Business Analysis, Business Forecasting, Customer-Focused, Data Integrity, Demand Planning, Digital Fluency, Financial Acumen, GxP Regulations, Lean Management, Master Data Management (MDM), Materials Requirements Planning (MRP), New Product Introduction (NPI), Problem Solving, Product Knowledge, Risk Awareness, Sales and Operations Planning (S&OP), Statistical Forecasting, Strategic Alignment, Supply Chain Operations, Supply Planning
東京都
1,000 万円 ~ 1,800 万円
大手外資製薬メーカー
Regulatory Affairs & Patient Safety(薬事・患者安全性)チームにおける PMS Planning and Management Head(製造販売後調査・管理責任者) として、製造販売後調査(PMS)の戦略立案、規制対応の推進、および患者安全性の確保を担う高いパフォーマンスを発揮するチームを率いていただきます。弊社の医薬品を必要とする患者さんの安全を守るため、重要な役割を果たしていただくポジションです。
現状に満足せず、既存のやり方に挑戦し続ける意欲を持つ方。法令遵守を徹底しながらも、PMS(製造販売後調査)の企画・運営方法に新たな発想や大胆な提案をもたらし、変革を推進できる方を求めています。単に現状を維持するのではなく、より良い仕組みへ改革していくことにやりがいを感じられる方を歓迎します。
・薬事および科学的な基盤知識
日本の医薬品医療機器等法(PMD Act)およびGPSPに関する確かな知識、またはGxP環境下での実務経験を有すること。コンプライアンスを最優先としながら、科学的な判断力を発揮できること。
・製造販売後調査(PMS)の専門知識
製造販売後調査および調査業務において5年以上の実務経験を有し、複数製品または複数疾患領域にわたるPMSプログラムを企画から実行、報告まで一貫して主導した実績があること。
・データベース研究の経験
市販後データベース研究の企画・実施経験を有すること。研究目的を科学的に妥当な研究デザインへ落とし込み、実行できる能力を備えていること。
・メディカルライティングおよび薬事文書作成能力
規制当局の要求水準を満たす高品質な薬事文書、試験実施計画書(Protocol)、解析計画書(SAP)、科学報告書などの作成経験と能力を有すること。
・戦略的思考力と成果志向
規制要件と科学的観点のバランスを取りながら、将来を見据えた判断ができること。明確な方向性を示し、複雑な状況下でも適切な意思決定を行い、責任感を持って成果につなげられること。
・ステークホルダーマネジメントおよびコミュニケーション能力
部門横断的かつ階層を問わない優れた調整力・コミュニケーション能力を有すること。規制当局との折衝に必要な自信と対外対応力を備え、社内外およびグローバル関係者との合意形成を推進できること。
・プロジェクトマネジメント能力
高い組織運営能力とタスク管理能力を有し、複数の複雑なプロジェクトを同時に管理しながら、品質・コンプライアンス・納期を確実に維持できること。
■語学力
・英語:ビジネスレベルのコミュニケーション能力(読み書き・会話) ・日本語:ネイティブレベルまたは流暢なレベルの日本語力必須
東京都
1,090 万円 ~ 非公開
プライム上場大手メーカー
・開示資料の作成、チェック
・監査法人対応
・業務改善、新基準導入等のプロジェクト推進リーダー
・連結Grメンバーの指導
・以下いずれかのご経験・スキル
・プライム上場企業経験
-公認会計士(あるいは論文式試験合格者)の方
-税理士(あるいは科目合格者)の方
-連結決算の実務経験 3年以上
・ビジネスレベルの英語力(メール、契約書等の確認)
・マネジメント経験 3年以上
【歓迎(WANT)】
・ビジネスレベルの英語力(口頭での説明・議論が可能)
・決算取りまとめ経験
東京都
1,230 万円 ~ 非公開
ファイザー株式会社
Position Purpose
The ELREXFIO Marketing Team Lead is responsible for developing and executing the ELREXFIO franchise strategy in Japan to maximize value for patients and deliver revenue and profitability objectives.
This role has business and P&L accountability for ELREXFIO, covering both the existing business and planned indication expansions. The role leads brand and launch planning, financial forecasting, performance management, and the effective prioritization of financial and human resources.
The position provides functional leadership to ELREXFIO Marketing colleagues and leads the cross-functional ELREXFIO team. It has no direct people-management responsibility but is expected to set strategic direction, align resources, coach colleagues, and foster a high-performing and collaborative team. The role also serves as a key interface with Japan Oncology leadership, the International Commercial Organization, and Global ELREXFIO teams.
■Primary Responsibilities
1. Business and P&L Leadership
· Deliver agreed revenue, profitability, and business performance objectives for ELREXFIO.
· Lead financial planning and forecasting, including the Operating Plan, long-range forecasts, latest estimates, and business scenarios.
· Monitor financial and non-financial KPIs, address performance gaps, and lead timely corrective actions.
· Manage the promotional budget and recommend effective allocation of financial and other resources.
· Partner with Finance, Analytics, Supply, and other functions to manage business risks and opportunities.
2. Franchise and Brand Strategy
· Develop and execute the long-term ELREXFIO franchise strategy, annual Brand Plan, and Plan of Action for Japan.
· Define strategic priorities, growth opportunities, sources of business, and investment choices across indications.
· Translate scientific evidence, market dynamics, and customer and patient insights into a differentiated value proposition and actionable commercial strategy.
· Optimize positioning, segmentation, targeting, customer engagement, promotional strategy, and channel mix.
· Adapt Global and International strategies to the Japanese market and ensure that Japan perspectives are appropriately represented.
3. Existing Business and Launch Execution
· Lead the sustainable growth and ongoing performance of the existing ELREXFIO business.
· Lead commercial strategy, readiness, and execution for planned indication expansions, including market shaping, positioning, targeting, customer journeys, key messages, field readiness, and post-launch optimization.
· Lead commercial input into opportunity assessments, forecasts, investment decisions, and scenario planning.
· Establish clear milestones, governance, KPIs, risk assessments, and mitigation plans.
· Monitor market dynamics, competitive developments, treatment patterns, customer insights, field feedback, and launch performance, and adjust plans as needed.
4. Cross-Functional and Functional Team Leadership
· Lead the ELREXFIO cross-functional team and align stakeholders around a common strategy, priorities, milestones, and measures of success.
· Partner closely with Medical Affairs, Market Access, Regulatory Affairs, Analytics, Finance, Supply, Legal, Compliance, Sales teams, and other relevant functions.
· Clarify roles, responsibilities, decision rights, and escalation pathways, and proactively resolve issues.
· Provide strategic direction, coaching, and development support to ELREXFIO Marketing colleagues and project members without direct people-management responsibility.
· Represent the ELREXFIO business in relevant Japan, International Commercial, and Global forums.
5. Operational Excellence and Compliance
· Ensure high-quality and timely execution of Brand Plans, launch plans, promotional materials, training programs, congress activities, and customer-facing initiatives.
· Establish effective governance and performance-review processes for the ELREXFIO business.
· Partner with Supply and relevant functions to anticipate demand and address potential supply or business-continuity risks.
· Ensure compliance with applicable laws, regulations, industry codes, Pfizer policies, and internal review and approval processes.
· Demonstrate high standards of integrity, sound judgment, and patient focus in all business decisions.
· Bachelor's degree or equivalent.
· A minimum of five years of pharmaceutical marketing experience.
· Demonstrated experience in brand strategy, Brand Planning, financial forecasting, performance management, and promotional-budget management.
· Experience leading complex cross-functional projects or initiatives in a matrix organization.
· Strong strategic thinking, financial acumen, analytical capability, and problem-solving skills.
· Demonstrated ability to influence senior stakeholders and align multiple functions without formal authority.
· Strong written and verbal communication and presentation skills in both Japanese and English.
· High standards of integrity, compliance, collaboration, and patient focus.
■Preferred Qualifications and Experience
· Experience in Oncology, Hematology, Specialty care, Advanced technology treatment areas such as Cell & Gene therapy or another complex therapeutic area.
· Experience leading a new product launch or indication expansion.
· Experience managing an established business while preparing for a future launch.
· Experience working with International Commercial, regional, or Global teams.
· Experience providing functional leadership, coaching, or development support to colleagues.
■Resources Managed
· ELREXFIO promotional budget and other allocated commercial resources.
· Functional coordination and prioritization of ELREXFIO Marketing and cross-functional project resources.
· No direct people-management responsibility.
東京都
1,300 万円 ~ 1,800 万円
外資製薬企業
Our vision is to become the most trusted source of medical information to facilitate optimal health management.
Our mission is to empower our customers with easy access to high-quality medical information to support the informed and appropriate use of company products and to generate actionable insights that contribute to product strategies.
As Medical Information Specialist in Japan, you'll experienced in delivery of high-quality medical information services, driving digital innovation and serving as the subject matter expert across the business. Ready to get started?
Join the mission of a global biopharmaceutical company — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
【Main responsibilities】
Experienced in medical information response delivery –deliver high-quality standard and customized responses for MI teams to use in addressing unsolicited requests from external customers, ensuring all content meets legal requirements, JPMA Codes of Practice, and company guidelines.
Drive digital transformation and innovation – actively participate in projects developing Medical Information services that provide customer responses through preferred channels while amplifying digitization and AI enablement.
Act as the Medical Information Subject Matter Expert – serve as the expert for MI services and industry best practice, reinforce the value of Medical Information through strategic business partnerships, and provide training to vendors and other stakeholders.
Active involvement in coaching colleagues on medical information best practices provide services to Japanese customers to reach their KPIS and specifically support them in achieving accreditation for independent working on medical information documents.
Develop therapeutic expertise – continuously build therapeutic area knowledge and cross-portfolio product expertise to enhance response quality and customer support.
Drive continuous improvement and customer insights – use advanced knowledge to propose improvement initiatives in Japan, Key Market and Global MI; assess customer needs through data analysis, monitor content usage and trends, and share insights with stakeholders.
Experienced as a project lead role for medical Information and manage the project to deliver outputs in timely manner as well as meet KPI
Ensure quality oversight and compliance – contribute to quality oversight of MI vendors, support audits, and external inspections, and maintain working knowledge of JPMA Codes of Practice.
Creation (including Searching the latest literature) and management of SRDs, medical information materials (Interview Form and KusurinoShiori), with high-quality and timely manner
Knowledge
Company products, Disease and its treatment, MS Office, Database, Compliance, Industry, Medical Writing
Strong understanding of Interview Form and Kusurinoshiori creating guidelines
Proven medical information experience within the pharmaceutical industry, including medical writing for technical MI documents.
Excellent Language skills for both Japanese and English at business situation.
Japanese: Must be fluent in Japanese for speaking, writing, and reading (native level),
English: Business English communication skills TOEIC Over 900, fluent in speaking, reading and writing.
Proven ability to proactively provide insights that support decision‑making, with confidence presenting these insights to senior leadership; experience or passion for process improvement or digital projects is a strong advantage.
Excellent communication skills (written, verbal, and interpersonal) in English, with a customer (Patients, HCPs, Caregivers etc.) ‑focused mindset and genuine passion for patient care
Ability to build effective relationships and collaborate with multiple stakeholders across geographies, cultures, and experience levels, while offering training or coaching to colleagues when needed.
Formal Education And/Or Experience Required:
Educated to degree level or higher in life sciences, pharmacy, or a related discipline, or equivalent professional experience. But not limited to
More than 8 years of pharma industry experiences (including maximum of two years of experiences as pharmacist)
Knowledge And Skills Desirable but Not Essential:
Outcome Oriented
Innovative Ideas
Contact Center Management
Project Management
Strong understanding of JPMA Codes of Practice, with experience applying these in a business environment; exposure to GxP‑related audits or inspections is an advantage.
東京都
600 万円 ~ 非公開
Meiji Seika ファルマ株式会社
・製薬業界の関連法規・業界動向の情報収集
・会社機関業務サポート(取締役会や株主総会サポート等)
・法律相談対応
・各種法令対応推進(営業秘密、個人情報、下請法、贈収賄等を含む)
・研修の実施
・LegalTecの導入及び運用
・その他上記に関連する業務
■組織
法務部
部長1名、G長2、計10名(含:嘱託1名)
・大手企業での法務業務経験又は、5年以上の大都市圏の中堅以上の法律事務所での企業法務経験
・製薬企業での業務経験(あれば望ましい)
・プロジェクトマネジメント、国際法務。M&Aの経験(あれば望ましい)
・英語に抵抗が無いこと
(業務の専門性以外に)
・多角的かつ現実的な回答を見いだせる実務能力
・ナレッジシェア(属人化脱却)への親和性
・LegalTec活用の積極性
・コミュニケーション能力
(業務の専門性以外に)
・多角的かつ現実的な回答を見いだせる実務能力
・ナレッジシェア(属人化脱却)への親和性
・LegalTec活用の積極性
・コミュニケーション能力
東京都
780 万円 ~ 非公開
日本イーライリリー株式会社
品質保証に関する業務を行う。製造指図記録書や試験記録書に関するデータ完全性の確認、中間品や資材のステータス変更や実績の入力、倉庫や製造エリアにおける問題解決、電子システムを使用したActivity Planningレコードの作成といった業務を行う。また、QAメンバーから依頼された会議で使用する資料の作成、製品の年次調査データのまとめや入力等のタスクを完了させることで、出荷判定や品質保証業務を支援する。
【職責】
・安全要件に従って行動し、安全衛生活動などの安全イニシアチブに積極的に参加し、安全関連の問題への対処に協力する。
・SOPを遵守し業務を遂行する。
・製造指図記録書の発行時における完全性の確認
・出荷判定を行うための、記録済み製造指図記録書の一次レビューやデータの入力
・倉庫・製造工程エリアに定期的に立ち会い、GMP プログラムと品質システムを監視し、運用担当者とサポート担当者の両方が適切な文書化慣行を遵守し、理解し、該当する手順に準拠していることを確認する。
・品質事象に対する品質判断/処理を行い、複雑な事象については他の担当者にエスカレーションを行う。
・電子システムを用いた中間品、資材等のステータス変更(Usage Decision等)
・電子システムを用いた報告書等の確認・承認等の処理
・会議、電話会議、製品の年次調査等に使用する書類/資料の準備
・文書のファイリング
・医薬品、医療機器、化粧品、化学業界における3年以上の品質管理または分析試験業務の経験(理化学試験)
・理系大学卒業以上
・日本語:ビジネスレベル以上
・英語:業務上のコミュニケーションが可能なレベル
兵庫県
557 万円 ~ 非公開
シミックCMO株式会社
・医薬品及び製剤原料の微生物限度試験及びデータ照査、分析機器管理
・環境測定
・水試験(サンプリング・検査)
・原材料や錠剤_ハードカプセル剤_粉末剤_注射剤等の製剤の理化学試験・物性測定検査
(指示書に基づく試験検査業務及びデータ照査、分析機器管理)
・医薬品GMPでの品質管理業務のご経験のある方
(理化学試験・微生物試験、水試験、環境分析など)
・基本的なExcel、Word等、PC操作ができる方
【歓迎要件】
・マネジメント経験
・医薬品GMPの知識、日本薬局方(通則・一般試験法・製剤総則)の知識
・分析機器(分光光度計、高速液体クロマトグラフィー、溶出試験)の操作経験
・英語力
【求める人物像】
・シミックグループのCMIC's CREEDに共感できる人
★CMIC's CREED★
以下URLをご参照ください
http://www.recruit.cmicgroup.com/recruit/identity/cmics-creed.html
静岡県
650 万円 ~ 非公開
シミックCMO株式会社
上記に加え、下記の業務経験をお持ちの方には各業務もご担当頂く可能性がございます。
・医薬品製造業許可の維持管理業務経験
・工場の品質保証システムの維持運用
・工場内各部門との連携による工場内の品質保証システムの改善
・出荷判定、品質情報、バリデーション等
・部門および工場内の教育訓練、設備管理関係、異常逸脱、変更管理、自己点検への貢献
・GMP適合性調査対応
・GMP文書管理
・国内外行政当局および顧客との品質に関する渉外業務
・医薬品GMPでの品質保証業務のご経験のある方
【歓迎要件】
・マネジメント経験
・製薬会社での薬事業務を有している方
・医療機器の製造業登録管理経験を有している方
・向精神薬製造製剤業許可管理経験を有している方
・薬剤師免許をお持ちの方
【求める人物像】
・シミックグループのCMIC's CREEDに共感できる人
★CMIC's CREED★
以下URLをご参照ください
http://www.recruit.cmicgroup.com/recruit/identity/cmics-creed.html
静岡県
650 万円 ~ 非公開
Position Summary
The Associate Director, GxP Quality Assurance plays a critical leadership role in supporting the establishment and maturation of the Japan Quality Assurance organization.
Partnering closely with the Head of Quality Assurance, this position leads the implementation and execution of Quality Systems, Quality Governance processes, and GxP Quality Assurance programs required to support a growing Japan Marketing Authorization Holder (MAH) organization. The role provides strategic and operational quality leadership across product launch activities, commercial operations, contractor oversight, quality event management, quality risk management and regulatory inspection readiness.
As the Deputy of Quality Assurance Manager (QAM), the Associate Director plays a key role in supporting decision-making for quality-related matters and provides independent quality oversight to ensure product quality, patient safety, supply continuity, and compliance with applicable regulatory requirements throughout the product lifecycle.
Key Responsibilities
Quality System Development and Quality Governance
•Establish and maintain the Quality Management System for the Japan MAH organization.
•Lead Quality Governance activities and provide strategic direction for Quality Systems and Quality Compliance programs.
•Serve as the Deputy of QAM and maintain appropriate backup and support mechanisms for critical QA responsibilities.
•Drive continuous improvement of quality processes, procedures and compliance programs.
Product Launch Readiness
•Lead Quality Assurance activities supporting product launch and commercialization in Japan.
•Ensure effective implementation and integration of Japan-specific regulatory requirements into the Global Quality System throughout the product lifecycle.
External Partner Management
•Conduct quality audits of external partners.
•Establish, negotiate and manage Quality Technical Agreements (QTAs) with Contract Manufacturing Organizations (CMOs), logistics providers, warehouses, call centers and other GxP service providers.
• Provide Quality oversight of outsourced activities and monitor compliance with applicable regulatory and
company requirements.
Market Release and Product Quality Oversight
• Ovesee CMO activities and Review and/or approve records supporting product release activities.
• Perform final quality review of significant quality events and provide independent quality assessments to
support product disposition and release decisions.
Quality Event Management
• Provide Quality oversight for Deviations, Change Controls, CAPAs, Product Quality Complaints, Quality
Information and other quality events.
• Review quality risk assessments, investigation outcomes and proposed corrective actions.
• Conduct quality reviews to support final quality decisions on significant quality issues.
• Ensure appropriate cross-functional collaboration and escalation when required.
Quality Metrics and Management Review
• Review quality trend analyses, Annual Product Reviews (APRs) and Management Review outputs.
• Lead escalation of significant quality risks that may impact product quality, patient safety, regulatory
compliance, or supply continuity.
• Monitor Quality System effectiveness through established quality metrics and performance indicators.
Regulatory Inspection Management
• Coordinate inspection readiness activities across Quality Assurance and other business functions.
• Lead inspection preparation, inspection strategy development and inspection management activities.
• Serve as a key Quality representative during regulatory inspections and audits.
•理系分野(薬学、化学、生物学、工学、理学、バイオテクノロジー等)における学士号以上
•製薬業界における品質保証業務経験5年以上
•GQP、GMP、GDP及び関連法規制に関する知識及び経験
•規制当局監査・査察への対応経験
•外部委託先(製造委託先、保管・輸送業者、コールセンター等)との品質関連業務経験
•市場出荷判定、逸脱、CAPA、変更管理、品質情報等に関する実務経験
•問題解決能力及び意思決定能力
•グローバルかつクロスファンクショナルな環境でのリーダーシップ経験
•ビジネスレベルの英語力及びネイティブレベルの日本語
【歓迎要件】
•品質保証責任者又は品質保証副責任者としての経験
•MAHにおける品質保証体制の構築・運営経験
•MAHにおける 製品上市準備及び上市後品質保証活動の経験
•品質システム、ガバナンス体制の立ち上げ経験
•規制当局監査・査察をリードした経験
•委託製造管理及び品質契約締結・管理の経験
•安全性部門又は薬事部門との業務経験
•CMC関連業務経験(原薬プロセス開発、製剤開発、分析法開発、CMC薬事等
東京都
1,500 万円 ~ 1,800 万円
ギリアド・サイエンシズ株式会社
1. Strategic Leadership & Medical Affairs Oversight
Provides overall vision and strategic direction for the Medical Strategy & Communications function in Japan
Leads the development and execution of Therapeutic Area (TA) medical strategy and Plans of Action (POAs) aligned with global and regional priorities
Drives strategic alignment among Scientific Communications, Medical Information, and Field Medical (MSL) activities
Ensures strong alignment between medical strategy and business objectives while maintaining compliance and scientific integrity
2. People Leadership & Organizational Development
Leads and manages a team of Medical Strategy, Data Generation and Scientific Communications.
Builds a high-performing organization through:
Clear goal setting aligned with company and Medical Affairs strategy
Performance management, coaching, and talent development
3. Cross-functional Strategy & Execution
Plays a key leadership role in cross-functional TA strategy and business planning (BPOA)
Partners with; Market Access, Regulatory Affairs, Marketing, Clinical Development, and Pharmacovigilance.
Provides medical input into: Product strategy, Market access plans, Launch readiness and lifecycle management
Ensures all cross-functional activities are executed in a compliant and patient-centric manner
4. Scientific Communication & Evidence Generation
Oversees development and execution of Scientific communication strategy(publication, congress, medical education and medical contents development)
Ensures high-quality, consistent, and compliant scientific messaging in scientific contents
Drives evidence generation activities in alignment with Medical Strategy (e.g., management of investigator-sponsored study, leading company-sponsored study, and/or database research etc)
5. Global & Regional Collaboration
Provides Japan-specific medical insights into global product development and medical strategy
Collaborates effectively within an international matrix environment
6. Governance, Compliance & Operations
Ensures adherence to: local regulations, company policies and highest ethical and compliance standards
Oversees departmental budget planning and resource allocation
Leads or contributes to organizational and strategic projects at country level and Regional/global level
Advanced scientific degree (MD, PharmD, PhD) preferred
Typically 10–12+ years of relevant experience in pharmaceutical/biotech industry
Strong experience in Medical Affairs
Significant people management experience
■Skills & Capabilities
Strong strategic thinking with ability to translate into execution
Deep understanding of:
Clinical science
Evidence generation
Healthcare system and access environment in Japan
Excellent leadership and team development capabilities
Strong cross-functional collaboration skills
High level of integrity and commitment to compliance
Excellent written and verbal communication skills in Japanese and English
※※Application Requirement※※
Please submit a one-page PowerPoint slide outlining your proposed medical strategic plan for Yescarta. You will be required to present it during the interview. (English)
東京都
1,800 万円 ~ 2,520 万円
非公開
【主な業務例】
・創薬開発品の導出活動
・導出活動のための資料作成、事業計画のブラッシュアップ
・市場動向の分析と戦略立案
・ステークホルダーとの良好な関係の構築
・資金調達関連に関わる主体的なCXOの業務サポート
・マッチングカンファレンスへの参加および運営
※少数精鋭組織のため、記載のない医薬品研究開発業務に従事していただくこともございます。
・創薬開発品に関する事業開発活動経験(5年以上)
・医薬品研究開発に関する一般的な知識
・契約に関する業務経験
・業務を推進するためのコミュニケーション能力
・海外でのネットワーキング活動経験
・英語力(ビジネス以上)
【歓迎条件】
・創薬開発品の導出活動経験
・神経変性疾患、特にアルツハイマー型認知症開発品取り扱いのご経験
・バイオベンチャーでのご経験
東京都
1,000 万円 ~ 非公開
ヤンセンファーマ株式会社
The Japan Project Team Leader (PTL) (P8) is a cross-functional R&D leader accountable for actively shaping and executing global asset development strategies through robust integration of Japan insights, working with guidance from TA Lead or senior leaders as needed.
The PTL serves as country counterpart to CDTL and R&D’s empowered country-level leader, ensuring cross-functional Japan considerations are systematically embedded in global decision-making, governance milestones, and delivery plans, additionally to being accountable for project delivery. This role requires strategic leadership, business understanding, stakeholder influence, and excellent execution capabilities by managing complex and uncertain environments for driving broader organizational impact.
【KEY RESPONSIBILITIES】
1. Strategic Business & R&D Leadership
・Lead country-level cross-functional Project Teams as an extension of the CDT, ensuring Japan function as integral contributors to global strategy, not only downstream executors.
・Ensure “one local voice” incl. local R&D and commercial alignment to provide input into global CDTs on project strategies for Japan.
・Generate and position high-quality Japan insights (regulatory, clinical, operational, portfolio, and commercial interface)
・Partner with the CDT and R&D in China/Japan and commercial to translate global strategy into robust, scenario-based country delivery strategies and enable in addition commercial success in Japan, addressing risk, feasibility, and value trade-offs. Ensure execution of country plans, with timely escalation of strategic, resourcing, and risk issues to the CDT and governance forums. Lead critical project issue resolution arising in R&D Japan in alignment with local or regional commercial and global CDTs.
・Maintain clear ownership of country-level R&D governance inputs, ensuring decision traceability and strategic coherence.
2. CDT & Enterprise Stakeholder Integration
・Serve as an important R&D country representative within the CDT, participating as a topic-driven contributor and extended CDT member,
・Act as a strategic interface and accountable for execution among:
- CDTL, PDL, PML, RPM, CPM
- Country R&D functions
- Country non-R&D stakeholders (MAF, NPP, MA, BU)
3. Project Team Leadership & Culture
・Foster a “one team” mindset across country Project Teams aligned to global and local priorities, accountability, and performance standards;
・Provide cross-functional leadership in decision-making, conflict resolution, and strategic trade-offs at the country level;
・Build teams with the right mindset, practices, and learning orientation, balancing rigor with agility and avoiding over-reliance on process for coordination;
・Continuously improve team effectiveness, insight generation, and strategic contribution to the CDT.
4. Governance, Communication & External Representation
・Ensure fit-for-purpose, decision-oriented documentation, including:
- Strategic insight briefs
- Provide locally aligned input into the GFLS and ADP for China and Japan
- Decision logs linked to global governance milestones
- Clear communication records aligned with CDT and commercial decisions
・Represent R&D externally as appropriate, including scientific forums, health authority interactions, and key stakeholder engagements, consistent with asset strategy and governance expectations.
Ensure consistent and aligned R&D messaging across country, regional, and global stakeholders
・At least 6 years in drug development including experiences of working in cross-functional matrix teams within a global R&D organization;
・Knowledge of global drug development and registration with understanding of pharmaceutical portfolio risk management;
・Working knowledge of China and/or Japan local practice, policy and regulation; and insight into what is required to be successful in the market also from commercial objectives;
・Track records in delivering as part of a cross-functional project team;
【Skills/Capabilities】
・Accountable, self-motivated, adaptable, and open-minded, with a strong can-do attitude;
・Strong analytical and problem-solving skills, with the ability to evaluate complex information, identify key issues, and recommend practical solutions;
・Demonstrates resilience and sound judgement under uncertainty, and takes ownership to drive results;
・Understands business priorities and development strategies, with the ability to connect project decisions to broader organizational goals
・Builds effective partnership and collaborates successfully across teams in a matrix environment;
・Effective stakeholder management, communication, negotiation, and project management skills;
・Demonstrates cultural agility and the ability to work effectively across diverse teams and organizational settings;
・Balances strategic thinking with execution excellence to drive change and deliver impact;
・Fluent in written and spoken English and Japanese.
【Qualification/Certificate】
・A scientific background with an advanced degree in relevant disciplines (e.g., medical, pharm, regulatory, quantitative sciences, business etc.);
・MD/PhD/PharmD/MBA preferred.
東京都
1,300 万円 ~ 1,800 万円
日本イーライリリー購買部は、健全なビジネスを維持するとともにビジネス部門および社外ビジネスパートナーと協業することによって、生産性およびイノベーション向上によりビジネスに貢献する社内で唯一発注権限をもつ部署です。
このポジションは日本在籍の購買部長を上司とし、間接購買の担当分野にてソーシングワークおよびプロジェクトに責任を持ちます。この業務にはデータ分析(支出、業界、マーケット、社内プロセス)やソーシングの戦略策定、パートナー選定および承認、社内外のパートナーとの協業、良好な関係性構築、リスクマネージメントおよび社内コントロールが含まれます。また、AIなどの新しいテクノロジーやツールを積極的に活用し、業務プロセスの効率化・生産性向上を推進する改善活動も期待されます。
新しいことに挑戦し、経験から学び、結果に反映させる気質が求められます。
<Job Responsibilities>
ビジネスニーズやプロセスを理解し、支出金額および社内外のマーケットを分析したうえでサプライヤー選定、コスト削減やプロセス構築に関する戦略を構築します。
ビジネス部門と協働しながら外部業者と入札や交渉を介して最適なパートナーを選出し、社内の規定を順守しながら、発注書の承認、契約書の締結など会社の代表として調達のプロセスを実行します。
取引先と良好な関係を保ち、リスクのコントロールをします。
社内規定を理解した上でインターナルコントロールに則り会社全体が順守できるように促進します。
AIツールや自動化技術を活用し、購買業務の効率化・標準化を図るとともに、既存プロセスの継続的な改善活動を主導します。
【必須資格】
科学、工学、ビジネス、財務、サプライチェーン、購買など、関連分野での学士号
購買、外部調達、関連資材の製造、または製薬業界(製造オペレーション、テクニカルサービス、材料科学など)での3年以上の経験
【歓迎要件】
製薬開発特に研究開発分野に関する知識・理解がある方
コマーシャル、技術、あるいはガバナンスの立場でサプライヤーと直接関わった経験
要件・納期・価格・品質のバランスを的確に判断し、優先順位をつけられる能力
高いビジネス判断力、プロジェクト管理、プレゼンテーション、コミュニケーション力
社内外の意思決定に影響を与えることができる方
各関係部署やサプライヤーとの協業
製薬業界での実務経験
交渉経験
SAP または Ariba を使用した購買業務の経験
Microsoft Excel(ピボットテーブル使用を含む),PowerPointおよびAI の実務スキル
兵庫県
1,100 万円 ~ 非公開
グラクソ・スミスクライン株式会社
スキル/Skill:
• Proven people leadership capabilities• Strong cross-functional collaboration and stakeholder management skills• Results-oriented mindset with high ethical standards and integrity• Deep understanding of pharmaceutical governance and compliance in Japan経験/Experience:• Significant experience in Medical Affairs within the pharmaceutical industry• Demonstrated leadership of Medical Affairs teams or functions• Strong experience in Oncology therapeutic areas• Experience supporting Oncology product launches• Solid understanding of the Japanese healthcare environment学位/資格/語学力 Education/Certification/Language:• BSc or equivalent advanced scientific degree• Fluency in Japanese and English
東京都
1,200 万円 ~ 1,900 万円
EAファーマ株式会社
・新薬の処方設計・製剤開発、難溶性薬物の経口吸収改善、付随するドキュメンテーション
・製剤に関する改良ニーズの把握、既存製剤の改良品開発
・製剤製造プロセスの確立と工業化検討、生産部門への技術移転
・国内外における治験薬の委託先製造管理と付随するドキュメンテーション
・製剤製造に係る国内外承認申請資料の作成及び照会対応
・生産におけるトラブル・変更に対する技術支援
・新薬の開発におけるCMC部門・非臨床のマネジメント業務
・国内外の会社の開発品及び市販品の製剤パートにおける導入評価
・当社開発品及び市販品の導出活動における製剤パートの資料準備及び対応
【業務の特徴】
医薬品ならではの規制をふまえつつ物理化学・化学工学的な専門性を発揮しながら製剤の設計を行い、臨床開発と連動し工業化・生産化検討により処方・製法をブラッシュアップしていきます。
上記を申請資料に耐えうるレポートとしてまとめ、製造販売承認申請の一翼を担っていただきます
・医薬品メーカーにおける製剤開発関連業務につき5年以上の経験を持つこと
・固形製剤の処方検討及び製法検討の経験を有すること
・チームやプロジェクトのリーダーを行い、業務遂行と人材育成の双方ができること
・海外を含め社内外の関係者とプロジェクト推進に向けたコミュニケーション能力を有すること
・高い安全意識を持ち、機器原理を理解し適切な取り扱いができること
・課題に対し解決までのストーリーを自ら構築し、具体的検証方法を導きだせること
・DIを意識したタイムリーなレポート作成を迅速かつ適切に行えること
歓迎されるスキル・経験
・レギュラトリ関連の一定の知識と実践する能力を有し、日常的に最新情報のウオッチができること
・バイオ医薬品等、経口固形製剤以外の製剤開発経験を有すること
・幅広い物理化学的知見とそれを応用展開する能力があること
・基本的理化学分析スキルを持ち、その原理原則を理解し応用展開ができること
・広い知識と経験から、発生し得る課題を事前に察知し対応することで課題を発生させないようにできること
神奈川県
600 万円 ~ 非公開
EAファーマ株式会社
品質管理責任者業務と以下部門のいずれかの業務マネジメント
・原材料、製品の試験検査及び評価に関する業務(治験薬を含む)
(原料試験、微生物試験、製品理化学試験など)
・製品の製造工程管理、環境管理及び評価に関する業務
【業務の特徴】
品質管理業務(分析方法、分析機器等)に関する高度な知識・スキルを活かし、GMP等の関連法規を遵守しながら品質システムの維持・向上を図るとともに、部門横断的な連携や継続的改善活動、課内マネジメントを通じ、高品質な医薬品を患者様にお届けする使命に貢献できる。
【業務の魅力】
福島事業所の品質管理業務を経営職の立場として、品質システムの運用、継続的な改善を主導し、課内の人財育成、業務効率化、適正品質の維持管理、技術力向上を含むマネジメントなど、組織全体の品質基盤強化に貢献できる。
また、全社視点での分析技術・品質レベル向上を目的に、技術部門やCMC部門と連携しながら、品質管理部内のマネジメントを推進でき、将来的には、品質マネジメント全体を俯瞰できるキャリア形成が可能である。
・医薬品GMPまたは治験薬GMP下での業務、マネジメント経験
・日局(通則、一般試験法)、IHCガイドラインを理解している
・手順書の作成・改訂経験(試験方法、機械の操作手順)
・理化学試験(錠剤の試験項目全般)、HPLCやGCの知識・経験
・医薬品の微生物試験の業務経験があることが望ましい
・人物的には、コミュニケーション能力が高く、課題に対して挫けず意欲的に取り組める方
<歓迎要件>
薬剤師資格があれば尚可
福島県
900 万円 ~ 非公開
EAファーマ株式会社
医薬品の製造業務、及びその他関連業務
(錠剤・顆粒剤・散剤の製造および包装作業)
※交替勤務がある(3交代制、2交代制)
※交替勤務は月曜~金曜での交替勤、4勤2休のパターンの2つがあり部署により異なります。
◆本ポジションでは、製造ラインの運営に関与しながら現場理解を深めていただき、将来的にはライン全体のマネジメントを担っていただくことを期待しています。
▼入社後
・製造工程(錠剤・顆粒・散剤等)の流れおよび運用の把握
・現場での製造業務への一部関与(工程理解のため)
・GMP・SOPに基づく運用状況の確認
・製造現場の課題把握および改善活動への参画
※必要に応じて現場理解を目的とした交替勤務に従事いただく場合があります
▼主に担う役割
・製造ラインの進捗管理・生産計画の実行管理
・人員配置・シフト調整の最適化
・GMP遵守の徹底および品質リスク低減のための管理
・製造工程における改善活動の推進(効率化・安定化)
・トラブル・逸脱発生時の対応および再発防止策の実行
・メンバー指導および育成
▼将来的な役割期待
・製造ライン全体の統括(ライン長)
・組織運営(人財育成・評価・配置)
・品質・コスト・納期のバランスを踏まえた全体最適の実現
・継続的な改善活動の主導および組織文化の醸成
【業務の特徴】
製造部では各工程で専門性を持つ人員を配置し、GMPに基づいた厳格な品質管理のもと高品質な医薬品の安定供給を実現しています。
本ポジションには品質意識を現場に定着させ、確実なオペレーションとして実行できる組織づくりが求められます。
<必須>
・医薬品製造業における実務経験(目安5年以上)
・製造ラインでのリーダーまたはマネジメント経験
・生産計画や業務進行に沿って業務を遂行した経験
<歓迎>
・メンバー指導・育成の経験
・製造ラインにおける改善活動の推進経験
【求める人物像】
・将来的にラインマネジメントを担いたい方
・品質意識を高く持ち組織に浸透させられる方
・課題解決を主体的に推進できる方
・改善や仕組みづくりに取り組める方
福島県
900 万円 ~ 非公開
東京セル医科学株式会社
■脂肪組織等からの各種細胞の抽出・加工・調整業務
■製造機器の適切な管理、日常的な点検、手順書(SOP)の新規整備・管理等に関する事務作業
■ヒト由来細胞の培養実務経験(修士・博士号歓迎)
■PCスキル(Excel等)【尚可】
■ベンチャーでの就業経験、多様なステークホルダーと円滑に折衝・調整ができる高いコミュニケーション能力
【求める人物像】
■少数精鋭のベンチャー環境において、自身の役割を限定せず臨機応変かつ柔軟に業務へ取り組める方
■最先端のバイオ技術や次世代の再生医療に対する関心が高く、継続的な自己成長を日々追求できる方
■周囲と良好な関係を築ける方
東京都
400 万円 ~ 非公開
The purpose of Pharmaceutical Project Management (PPM) role is to have overall responsibilities for working with the leadership of the Global counterparts and the corresponding Affiliate Business Unit functions to assure development and implementation of appropriate pharmaceutical development strategies and plans from early-phase to end of the lifecycle of the molecule on time and on budget in the relevant therapeutic area. The key deliverables are full portfolio coverage, simultaneous development and launches, and creating value across the entire product life stage. The role will be assigned to one or more Therapeutic Areas (Immunology, Neuroscience, CMH or Oncology).
PRIMARY RESPONSIBILITIES:
1. Align the Portfolio, Development to BU Strategies
・Engage Medical, Clinical, Regulatory, CMC/Manufacturing, Marketing, Safety Functions and other functions to deliver the portfolio and align drug development strategies with BU strategies.
・Provide leadership for development of Product Lifecycle Plan in alignment with the Therapeutic Area development and commercial strategies.
・Deliver necessary information and data about the new/ongoing projects for the portfolio and business plan management.
2. Lead Value Maximization Through Product Lifecycle
・Lead to develop robust Japan Project Plan that fortifies linkages to Asset Profile, Value proposition, MMFA (Manufactured Marketed Forms Agreement) and scope, assures quality and consistency of content, and translates into operational objectives.
・Translate Japan marketing, medical and regulatory needs for the molecule/new indication/line extension (including new formulation / delivery solution) into the global integrated plan.
・Lead overall launch readiness and co-lead the affiliate overall launch readiness in collaboration with respective commercial leader.
・Ensure post-marketing activities including issue management are managed well by providing leadership to cross-functional collaboration.
3. Deliver Results
・Lead the team to meet or exceed overall project goals (completion of clinical studies, CMC deliverables and NDA/device preparation, submission and approval timing, etc.)
・Deliver project milestones on time, on budget, within scope, and to high quality standards by holding functions accountable for achievement of key project deliverables in alignment with the agreed to project plan and in compliance with Japan quality standards.
・Identify areas for where process improvement will enable better results and work with discipline leaders to impact change.
4. Apply Project Management Knowledge and Processes
・Work with Japan governance to authorize project scope and plans. Scope and plans should be based on broad scenario planning, robust risk management planning, and reliable execution (timeline, FTE, and budget) planning which ensures all functional requirements are appropriately reflected.
・Develop and implement stakeholder, global, and team communication plan to ensure alignment with medical affairs strategy and product development strategy. Lead external communication strategy related to development (e.g. data read outs, regulatory outcomes). Provide rapid and quality responses to external customers.
・Monitor and control performance of the overall project that utilizes appropriate tools and techniques (project systems, budget: plan vs. actual, FTE: plan vs. actual, etc.), and ensure change management process is in place to manage scope and plan.
5. Build Winning Culture Through Effective People Management
・Coach team members by providing timely constructive feedback and recognition to good results and behaviors.
・Create an environment that encourages intelligent risk taking and fosters wining culture within the team.
・Support the growth of project management expertise in Lilly Japan through participation in shared learning forums, staff meetings and training programs.
QUALIFICATION REQUIREMENTS:
Knowledge and Skills
・Strong leadership skills.
・Excellent interpersonal and communications skills both in Japanese (native, fluent, or proficient) and in English (native, fluent, or proficient), communicate clearly with diverse interpersonal styles and able to develop credibility cross functionally.
・Ability to influence others positively, negotiate effectively, and manage conflicts effectively.
・Ability to lead and deliver in the volatile, uncertain, complex, and ambiguous environment.
・Project Management Expertise
・Strong strategic and logical thinking skills.
・Strong conceptual skills.
・Understanding of Project Management concepts, tools, and skills.
・Business acumen.
Education and Work Experience Desirable to Perform Role:
・A degree in healthcare, science or business discipline (BS/MS/PhD, MD, MBA).
・Minimum 3 years of experience in R&D function(s).
・English language proficiency required, or substantial experience as an active member or a leader of a global team.
Additional Preferences
・Working experience in pharmaceutical industry.
・Drug development knowledge and expertise.
・Qualification in project management professional (PMP).
兵庫県
600 万円 ~ 非公開
外資スペシャリティファーマ
戦略面の卓越性: Medical Affairsや国内外のビジネスパートナーと協働し、ブランド計画やメディカルプランに基づく戦略・戦術を計画・実行する。
医科学の卓越性: 製品や適応症、技術について深く最新の知識を持ち、内外の関係者に価値ある情報や洞察を提供し、高品質な医科学を担保する。
オペレーションの卓越性: Medical Sffairsチームや関係者と連携して開発・実行を管理。スケジュール、予算、法令遵守を徹底する。
専門家連携・科学的交流: 社内外の科学リーダーや医療従事者、学会等との交流を主導し、科学的かつバランスのとれた情報交換を推進。得られた洞察を戦略に反映。
競合情報(CI): 競合分析を行い、メディカルプランの計画・実行に質の高いインプットを提供。
ガバナンス: 日本およびグローバルの各種審査委員会のレビュー・意思決定プロセスを主導。
臨床開発支援: 臨床開発チームと協働し、臨床戦略の構築や規制当局(PMDA、厚労省)との連携、臨床試験関連文書の医療レビューを支援。医療専門家の選定、臨床試験運営サポートも行う。
社内医療専門家(医師資格保持者の場合): 薬剤安全、医薬品監視、品質監査など企業の活動を医学的に支援。
ビジネス支援: 社内外の関係者と協働し、日本国内の事業推進をリード・支援。
人材マネジメント: 担当の場合、メディカルスタッフやチームの管理・育成を行う。
日本の製薬・バイオテクノロジー企業において、グローバル環境でのメディカル/サイエンティフィックアフェアーズ分野で10~15年以上の成功実績
医学・科学の専門家(シニアレベル)およびオペレーション・事務職を含むクロスファンクショナルチームのマネジメント経験
医学教育、医療経済・観察研究、科学的コミュニケーション、論文発表、後期開発品の臨床開発などの経験・知識
日本でのIND/NDA申請、NHI価格交渉、製品上市、製薬製品のライフサイクルマネジメント経験が望ましい
呼吸器、感染症、循環器領域の知識と経験が強く求められ、希少疾患やネグレクテッドディジーズの経験があれば尚可
必須のスキル・能力
日本語ネイティブレベル、英語ビジネスレベルの高いコミュニケーション能力(非常に重要)
高い倫理観とコンプライアンス意識。日本の製薬業界の規制・ルール・ポリシーおよびグローバルポリシーの理解
製薬ビジネス全般(研究開発、製造、商業化)の深い理解。戦略的かつ論理的思考力、分析力に優れ、細部への注意力や正確さを持つこと
医学と政策の橋渡しができるコミュニケーション力。複雑な科学情報を分かりやすく効果的に伝える能力。日本語・英語でのプレゼンテーション能力や交渉力も優れていること
国内外の組織とチームプレイヤーとして協働し、権限がなくても影響力を発揮できる能力
学歴・資格・その他
国内外出張が可能(国内外の学会、本社訪問等)
修士号(薬学、製薬、臨床・生命科学等)が望ましい
博士号(Ph.D.)や医師免許(日本で有効)保持者は優遇
学士号保持者でも豊富なMA経験があれば考慮される
医療従事者の応募歓迎
臨床開発経験があれば有利
東京都
1,200 万円 ~ 非公開
Global Pharmaceutical Company
Company OverviewAt our company, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 47,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. #JoinOurTeam
Organization OverviewCommunications in Japan is embedded within the company's Japan affiliate to lead its internal and external communications, advocacy and environment shaping efforts working with cross functional partners.ResponsibilitiesCorporate Communications (Digital Focus):As a core member of the Corporate Communications Team, this role leads digital-focused corporate communications and supports both internal and external corporate communications programs under limited supervision by leadership. By strategically leveraging digital channels, including the corporate website and social media, the role enables the clear and effective communication of the company’s values, purpose, strengths, and distinctive identity, strengthening the company’s corporate reputation both internally and externally.From a digital communications perspective, this position leads the development and execution of consistent corporate messaging and brand expression. The role supports the building of trust and engagement with a wide range of stakeholders, including media, the general public, patients, job seekers, and employees, while ensuring alignment with corporate strategy and brand standards.Key Job Accountabilities:・Own the strategic management and continuous improvement of the corporate website as a core owned media platform, ensuring content accuracy, relevance, timeliness, regulatory compliance, and alignment with corporate strategy and brand standards.・Lead the planning, creation, and optimization of digital content across corporate digital channels, including website and social media, to effectively engage key target audiences such as media, the general public, patients, job seekers, and employees.・Manage corporate social media channels, including content development, editorial planning, community management, and performance optimization, to support corporate reputation, brand positioning, and employer branding objectives.・Oversee social media advertising initiatives, including campaign planning, budget management, execution, and performance analysis, in collaboration with internal and external partners.・Establish and enforce digital governance frameworks, including content guidelines, approval processes, and cross-functional coordination with global, regional, and local stakeholders.・Drive integrated digital communications aligned with the company’s business strategy, corporate priorities, key messages, and strategic initiatives.・Ensure brand consistency and integrity across all digital touchpoints through effective management of corporate brand assets and adherence to brand governance standards.Additional Information・Travel : Local travel will be required time to time including 2 days working from the office (either in Tokyo or Kobe)・International Travel might happen once a year.
・A bachelor’s degree in communications, Public Relations, Digital Media, Journalism, or a related field is preferred; equivalent knowledge and experience will also be considered. At least 5 years of experience in corporate or digital communications, preferably within the pharmaceutical or regulated healthcare industry
・Strong experience in digital content strategy, website management, and social media communications to support corporate reputation and internal engagement
・Ability to influence senior stakeholders and guide decision‑making through data‑driven digital communication insights
・Excellent written and verbal communication skills in English and Japanese, including experience developing executive‑level and digital‑first communications
Additional Skills/Preferences
・Successful experience working with cross-functional teams, including collaboration and consensus building
・Experience in crisis communications
・Must be agile and innovative: Leverages an agile and creative mindset to adapt to change and drive innovative value creation, continuous process improvement, and proactive learning through new technology, processes, and people
複数あり
770 万円 ~ 非公開
大手外資製薬会社(オンコロジー領域)
・製品戦略に基づき、資材・イベント・デジタル施策の計画・実行
・KOLマネジメントの遂行
・領域の疾患啓発活動の統括
・関連する社内及び社外ステークホルダーと連携し、製品価値の最大化
・英語:中級 ビジネスレベル
複数あり
1,100 万円 ~ 1,800 万円
大手外資製薬メーカー
プロジェクトのスケジュール、品質、予算管理に責任を持ち、試験間やプログラム全体の運用調和を図ります。
規制申請の臨床部分の計画と実行を推進し、進捗をモニタリング。課題は速やかに報告・エスカレーションし、円滑なプロジェクト運営を実現します。
関連する科学または医療分野の修士号以上を有し、製薬業界での臨床研究経験が最低8年必要です。非常に高いプロジェクトマネジメント経験が求められ、多機能チームを効果的にリードした実績が必要です。
■資格・スキル:
強力なプロジェクトマネジメント能力、横断的かつ戦略的リーダーシップ、優れたコミュニケーション能力とビジネス感覚が求められます。個々のメンバーとチームを活性化し動機付ける高パフォーマンスなクロスファンクショナルチームを推進できる能力が必要です。顧客(医師、科学者、各分野のマネージャー)や関係者と効果的に連携し、期待値を設定・管理するための優れた対人スキルも必須です。
東京都
1,200 万円 ~ 非公開
外資系製薬会社
Person should be at ease interacting with local and global stakeholders in English and Japanese.
東京都
1,350 万円 ~ 非公開
外資系スペシャリティファーマ
スタートアップ組織での経験や希少疾患領域での経験があれば尚可
東京都
900 万円 ~ 非公開
ロシュ・ダイアグノスティックス株式会社
顧客へのエンド・ツー・エンド(E2E)配送オペレーションを統括し、配送ネットワーク全体の効率化、直接物流費の削減、および高品質な物流ガバナンスを推進します。3PL管理、受発注管理、配送コントロールに加え、大規模な戦略的プロジェクト(配送頻度の再設計、倉庫自動化、Spare Parts管理やcobas link等の業務統合)の現地責任者(ローカルオーナー)として牽引します。
【主な役割と期待事項】
・3PLマネジメント: 3PLパートナーのパフォーマンス・品質を管理し、信頼性と費用対効果の高い配送体系を維持・運用
・配送コストの最適化: 物流ネットワーク全体の効率化を推進し、最高のオペレーションパフォーマンスとコスト削減を両立
・E2E 受受注・配送管理: 受注から納品に至るシームレスな受発注オペレーションを統括
・戦略プロジェクトの推進: 倉庫自動化、配送頻度の最適化、主要システムの導入・統合などのローカル導入を牽引
・組織効率の追求: リソースの有効活用、スケジュールおよび業務目標の確実な達成
・サプライチェーン実務(5年以上): E2Eオペレーション管理(在庫、配送、3PL管理、受発注)の実務経験 ※ヘルスケア業界経験は不問
・システム活用力(5年以上): SAP ERPおよび需要予測・計画システムの使用経験(データ精度管理・レポート作成を含む)
・ピープルマネジメント経験(2年以上):育成・パフォーマンス管理を行い、多様なメンバーを率いて成果を最大化させたチームマネジメント経験
【必須スキル】
・コスト最適化力: 品質を維持しながら費用対効果の高い代替案や調達プランを立案・実行する能力
・在庫最適化力: 完成品、予備部品、主要サードパーティ調達品の最適在庫レベルを設計・維持する能力
・3PL・物流管理力: パフォーマンス管理、問題発生時のエスカレーション、プロセス改善を通じたコスト削減と改善力
・語学力: 英語 Fluentレベル(グローバルとの断コミュニケーションを円滑に行えるレベル)
【歓迎経験・スキル】
・3PL・物流ベンダー側での実務経験(メーカー経験不問): 物流企業・3PLにおいて、荷主(メーカー)向けの配送管理、オペレーション改善、コスト削減提案、またはプロジェクト管理を主導した経験
・S&OPプロセス運用: 月次S&OPサイクルを主導し、数量・供給前提について各部門の認識をすり合わせる能力
・デマンドプランニング: サービスレベルと在庫保持コストを最適化する需要予測モデルの構築・運用能力
【求められる資質・コンピテンシー】
■ビジネスアキュメン(業務知識・視点)
・専門知識: 高度なサプライチェーンおよび倉庫管理のプラクティス知識
・データ駆動型アプローチ: 需要シグナルや市場データを正確な供給計画へ落とし込む能力
・着荷コスト視点: 3PL・サプライヤーの取引条件が総着荷コスト(Total Landed Cost)に与える影響の深い理解
■対人スキル & リーダーシップ
・外部パートナー交渉: 社外の主要ステークホルダーや3PLとの高度な交渉・合意形成力
・透明性と決断力: 財務責任者(Head of Finance)や他部門とオープンで確固たるコミュニケーションを維持する力
・推進力と変革力: 情熱と説得力で組織を共通目標に引き上げ、全社視点から他部門との対立を解消する力
■概念化スキル & 戦略的思考
・イノベーション創出: 急変する環境下でオペレーション効率を最大化する柔軟で創造的なソリューション提示
・グローバルとローカルの接続: ロシュのグローバル戦略を解釈し、日本のローカルオペレーションに適合・着地させる能力
・アジリティ & 危機管理: 曖昧な状況下での迅速・的確な状況把握と、予期せぬ物流危機や供給混乱に対する優れた対応力
東京都
800 万円 ~ 非公開
あすか製薬株式会社
・非臨床実験データからの臨床予測
■開発段階(第Ⅰ相~Ⅳ相試験)
・グローバル開発に必要な様々な臨床薬理試験の実施計画立案
・臨床薬理試験デザインの立案・治験実施計画書の作成支援
・解析計画書の作成
・データ解析の実施、報告書の作成
・Modeling & Simulationを用いた臨床試験成績の予測
・Simulationを用いた小児用法・用量の推定
■承認申請業務
・申請資料M2臨床薬理関連の作成
・照会事項対応
【魅力】
・会社にとって極めて重要な役割を担う臨床薬理スペシャリストとして、高い裁量をもって主体的に業務を推進できる。
・事業への影響度が高い臨床薬理領域の専門家として、研究部門及びCMC部門と連携し、高い視座と広い裁量のもと自律的に業務を遂行できる。
・研究開発戦略の企画部門(臨床企画部)にて会社の成長に重要な貢献を果たす臨床薬理スペシャリストとして、主体性と裁量を発揮しながら業務を牽引できる。
・製薬企業、CRO、アカデミア等での臨床薬理または薬物動態関連の実務経験
・新薬開発の合理的な意思決定が必要となる中、最新の臨床薬理学/トランスレーショナルリサーチの習得に貪欲で、斬新なアイデアを提案し実行に移すチャレンジを厭わない素地を持つ方
<歓迎要件>
・PK/PD解析、Modeling&Simulationを実務で使用できる方
・臨床薬理試験計画の策定~申請までのご経験のある方
・規制当局との議論が可能な方
・部門横断的に研究・開発を進められる方
東京都
720 万円 ~ 非公開
日系製薬メーカー
MR実務経験2年以上
MR認定資格をお持ちの方
【歓迎要件】
糖尿病、リウマチ領域の経験者
複数あり
600 万円 ~ 非公開
日系製薬メーカー
抗不眠症薬、糖尿病治療薬、リウマチ治療薬、骨粗鬆症治療薬などを中心にMR活動を行っていただきます。
MR実務経験2年以上
MR認定資格をお持ちの方
【歓迎要件】
糖尿病、リウマチ領域の経験者
複数あり
600 万円 ~ 非公開
-
職種から求人を探す
-
業種から求人を探す
-
勤務地から求人を探す
-
年収から求人を探す
転職支援サービスお申し込み
