Jobs list of Pharmaceutical

【大阪】再生医療等製品のCMC研究および製品化検討（研究員またはリーダー候補）

能力次第で様々な成長の機会を掴んでいただける可能性があります。

6 - 10 million yen Osaka Pharmaceutical Research & Development

Company overview: A pharmaceutical manufacturer listed on the First Section of the Tokyo Stock Exchange.
Responsibilities: ■職務内容：研究開発段階にある再生医療等製品（特に細胞加工製品）のCMC研究および製品化研究製剤化検討（剤型設計、保存法の開発）
投与デバイス開発
製法検討（主に下流工程）
その他周辺技術（製造機器、容器施栓系、輸送法等）の開発
治験施設への調製手技移転
日米における治験届・承認申請／IND・BLA業務
上記に限らず、細胞加工製品の開発において初期から後期まで幅広い分野で活躍いただきます。
■この仕事の魅力：新たな医療ソリューションの社会実装・事業拡大の最中にある革新的な再生医療等製品の開発においては、CMCの貢献できる範囲は広く、意欲さえあれば、セクションの垣根を越えて、未知の領域に幅広く挑戦していただくことができます。また米国子会社や海外医療機関との連携によるグローバル開発を進めており、国際感覚やダイバーシティを感じることができる環境です。

■入社後のキャリアパス：業務に必要な専門知識を磨いて頂くため、国内外の学会や研修に積極的に参加することを奨励しています。また海外子会社と協働して医薬品の研究開発を効率的に進め、且つグローバルな視点で考動できる人材を育成するために、海外子会社への短期或いは長期派遣の機会もつくっています。更に、立候補制による海外留学公募制度や他部門への短期派遣制度を設けています。
長期的なキャリアパスとしては、専門性をより高め個人の力で成果を出すスペシャリスト人材、あるいは組織力を最大限に活かして成果を出すマネジメント人材に分かれ、各人の資質や希望を踏まえて、上司と相談しながらキャリアパスを描いて頂く事が可能です。
製剤研究ユニットには他社で活躍後キャリア入社した社員も多く、すぐに職場に馴染み、前職でのご経験を活かして活躍されています。入社後早期にマネジメント職に着任頂いた方もおり、能力次第で様々な成長の機会を掴んでいただける可能性があります。

■職場の雰囲気：40歳未満が6割を占め、若く活気のある職場です。専門性の高いベテランのバックアップの下、若い時から重要な業務にアサインされ、グローバル開発に挑戦することが出来ます。高い心理的安全性が担保されており、若手から年長までが、垣根なく意見し合い、チームで難題を超えて、革新的な製品を世に届けようとアジャイルに取り組んでいます。

Quality Assurance Senior Manager

Full Remote QA Senior Manager position

12 - 15 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: The company is a foreign-affiliated pharmaceutical company.
Responsibilities: Provide strong support team management for GQP Head on day-to-day basis
Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS
Perform other duties as assigned such as described below, but are not limited to:
Provide support for regulatory agency inspection readiness and requests
Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
Support business develop

Account Manager

Sales incentive: Every quarter+ Annual(5 times per a year)

5 - 8 million yen Tokyo Pharmaceutical Sales / MR

Company overview: We provide medical and security services, specializing in healthcare, safety, and logistics. Our 24/7 support system spans over 90 countries, ensuring the health and safety of employees worldwide. We offer risk management, emergency support, and consulting services. Our assistance services are delivered by medical and security experts, supporting sustainable business operations by prioritizing employee safety. Our mission is to facilitate safe and sustainable business practices globally.
Responsibilities: Manage a portfolio of SME (small/medium) client accounts, either with direct ownership or part of an Account Management Team overseeing a pool of clients, through all stages of the client journey from onboarding, engagement & utilisation, account extension and specifically focused on timely renewal execution as per the defined process.
Consistently demonstrates an Intermediate level of the following competencies:Develop, manage, and progress a pipeline of renewal and extension opportunities to support successful timely closing and reporting.
Value and Targeted relationship selling methodology
Adaptability, creativity, innovative and uses initiative to drive success measures.
Strategic thinking and critical judgment.
Customer orientation (internal and/or external customers).
Technical knowledge of our services
Commercial acumen, including the ability to negotiate successfully to protect profitability and increase gross profit

Consistently demonstrates an Intermediate level of the following competencies:Time management, responsiveness, and priority setting
Verbal, presentational, and written communication skills
Self-driven to continue to develop as an Account Management professional

Consistently demonstrates a Proficient level of the following competencies:Teamwork, alongside individual ownership, and action orientated mindset

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Dermatology Medical Manager

A highly productive work environment

10 - 17 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: JOB POSITION PURPOSE
The MA role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical.Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes.
MAIN RESPONSIBILITIES:
Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.
Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in dermatology.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (in collaboration with the Health & Value team) and ensure timely publication of data.
Demonstrate medical and scientific leadership and expertise
Provide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.
Contribute to achieving the department/team goals, and/or participate in cross-organizational projects as a core member and provide guidance to deliver the results.
Play an active role in supporting members in the team/organization with the line manager to move towards its goals
Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and therapeutic area(s) in collaboration with office medical
Identify unmet medical needs and healthcare disparities in the assigned asset(s) and therapeutic area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the therapeutic area(s) and asset(s) to establish collaborative scientific relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Establish a highly reliable, long-term relationship with stakeholders.
Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
Maintain and enhance the cross-BU alignment on metrics
Ensure to collect necessary information and analyze insights prior to the meetings in order to provide deep medical and scientific expertise to stakeholders and HCPs
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus
Align, contribute, and collaborate with relevant internal stakeholders
Provide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.
Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.
Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.
Ensure awareness of responsibility for reporting adverse events
For all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

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Hematology Medical Affairs Senior Manager

充実したキャリア支援制度／生産性高く働ける環境

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: The MAS role family comprises a variety of medical scientific specialties, such as office Medical (oMAS) and field Medical scientist (fMAS).Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Lead and develop a team of fMAS to maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes with collaboration with office MAS. Main responsibilities:
People DevelopmentGuide and develop members in order to contribute to optimization of product values from the scientific point of views
Contribute to developing team members through appropriate assignments, coaching, appropriate appraisal and constructive feedback
Effectively manage through and lead the change in an evolving healthcare environment
Collaborate effectively and demonstrate leadership and teamwork with peers, internal stakeholders and external customers that inspires alignment and partnership on a shared vision or strategy

Demonstrate medical and scientific leadership and expertiseProvide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.

Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and disease area(s) in collaboration with office medicalIdentify unmet medical needs and healthcare disparities in the assigned asset(s) and disease area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the assigned disease area(s) and asset(s) to establish scientific peer level professional relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in the assigned area.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (incollaboration with the Health & Value team) and ensure timely publication of data.

Establish a highly reliable, long-term relationship with stakeholders.Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus

Align, contribute, and collaborate with relevant internal stakeholdersProvide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with Medical Affairs HQ colleagues and cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.

Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.

Ensure awareness of responsibility for reporting adverse eventsFor all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

As neededContribute to Business Development in the assigned area(s): In collaboration with Japan Medical Lead, Japan Medical Affairs Product Lead, Global MA members and other members from relevant functions, identify unmet medical needs and candidate therapies for potential medical interventions in the assigned disease area(s) in Japan through medical activities such as advisory boards and consultations with medical experts while keeping confidentiality.
Rapidly respond to critical supply issues from the medical perspective (e.g., rapid communications with academic societies and regulatory authorities)

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Lung Cancer Medical Affairs Associate

A highly productive work environment

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: MAIN REPONSIBILITIES:
Contribute to the development and implementation of a product strategy as a core member of the Product Team by conducting medical strategy and delivering medical and scientific advice both internally and externally to ensure that the short and long term business goals of assigned products are achieved and that the interests of the customer and company are safeguarded.
Ensure implementation of appropriate global and Japan medical strategies into actions by acting as an interface with regional and global asset and marketing colleagues
*Non-manager gain support from Sr. Manager to fulfil responsibilities
Execute Medical plan to meet unmet medical needs related to products in the assigned area
Create Medical Plan in the assets in collaboration with Therapeutic area Medical Team Lead.
Execute some part of Medical Plan in the assigned area such as medical advisory board meeting, publication, promotional documents review in collaboration with Therapeutic Area Medical Team Leads.
Provide information on customer’s feedback on product development and life cycle strategies to related divisions/department in the company.
Support promotional document review in collaboration with Therapeutic area Medical Team Lead
Support medical/scientific education to MRs in disease areas.
Medical & Scientific communication (Meet domestic/ global medical KOLs and provide/exchange scientific information)
Establish a good and highly reliable relationship through non-promotional activities such as scientific exchanges (e.g. discussion using latest research papers and follow-up of contents of academic conference presentations) with domestic top-level medical KOLs in the assigned area.
For creating Medical Plan, acquire extensive medical/pharmaceutical information and gather latest medical information in the assigned area.
In response to UMR (Unsolicited Medical Request: spontaneous request for medical information), provide accurate, high-quality and unbiased information to important customers, stakeholders and medical relevant colleagues.
Medical & Scientific communication (Meet domestic KOLs and provide/exchange scientific information)

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Pharmacovigilance Associate

PV Associate position in Tokyo based maker

5 - 8 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client is an international pharmaceutical company.
Responsibilities: 市販薬ならびに治験薬の国内及び外国における有害事象情報を収集、評価、検討し、PMDAならびにGlobal へ報告
市販薬ならびに治験薬の適正使用に関する安全性情報を医薬関係者等へ伝達する資料の作成
GVP省令ならびにGCP省令で求められているRMP、安全性定期報告等その他安全性業務に関する法規制の要求事項についての対応
GVP業務委託先製薬企業と連携の上、ファーマコビジランス業務が適切に行われるよう調整
GVP業務委託業者(CRO)の業務遂行状況を管理し、指導
Global PVならびに海外の規制情報の要求事項を理解し、ファーマコビジランス業務を遂行
経験の浅いメンバーを日常的にサポートおよび指導を行い、メンバーの育成に貢献
既存の業務プロセスの改善を率先して実行

Access Strategy Senior Manager

Senior Manager position at global mega pharma

12 - 18 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Overview:Develop a compelling access strategy tailored for New Asset to stakeholder interests and needs and leads strategic & tactical planning for market access activities to ensure optimal patient access with appropriate price setting.
Drive a Local/Regional/Global cross-functional team to develop and implement access strategies for assigned assets.
Scrutinize the commercialization plan for the assigned asset from pricing &reimbursement perspectives
Obtain endorsements from TA Leads to implement access strategies.

Main Responsibilities:Develop and implement access plans for assigned assets, which include scenario-based pricing assumptions with strategic initiatives, secure patient access and identify opportunities for accelerating launch timing.
Investigate and build deep understandings of key stakeholders’ (payers, market access customers) needs and reflect these insights into business/access planning processes via leveraging real-world databases and information in the following areas: Epidemiology: Patient dynamics, pathology, genetic background, Diagnosis & treatment guidelines
Market Environment: Current market size, competitive landscape analysis
Physician/Patient/Payer Insights: Unmet medical needs, burden of Disease/QOL
Local/Overseas access environment: Policy, HTA/Reimbursement system

Lead discussions and presentations to senior management to get required funding for launch optimization projects, including HEOR, HTA, RWD based data generation, as well as unbranded campaigns, etc., identified through cross functional discussion.
Work in close alignment and cooperation with a cross-section of colleagues (Global Access & Value, Global Commercial Development, Global Medicine Team, MA, DJ, Business Unit, A&V, P&PA, and BAI) through JMT/JVT/JAT.
Participate in JDC/J-PRC for portfolio entry, Global DP3 and Japan buy-up etc. through asset assessment in related TA as required.
Develop and include value claims for the brand at NDA to support optimal access.
Support NAA on developing reasonably accurate Long-rage revenue/expense/demand forecast for company pipeline assets and BD projects until 18 months prior to approval.
Support NAA on developing data, insights and recommendations for Strategic Plans that include strategies, tactics, and programs to maximize the long-term potential of development compounds, and obtain senior management endorsement.

Pharmacoepidemiology Scientist

Position at global mega pharma with very strong pipeline

8 - 14 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
Responsibilities: Responsible to lead safety observational studies as scientific lead and to deliver deliverables

 Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice)
 Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective.
Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases)
Review and develop study report/publications.
Lead scientific discussion in cross functional team and in discussion with regulatory agency.
Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence.

Support non-regulatory mandatory safety observational studies

Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies.
Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders.

Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle

Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products.
Contribute to Japan Risk Management Plan (RMP) development, periodic report development.
Review and develop query response to regulatory authority.
Demonstrate knowledge of relevant global and local regulatory requirements and practices
Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities.

Contribute to organizational RWE capability development

 Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology.
Provide pharmacoepidemiology related trainings.
Support system/process development to enhance productivity or increase scientific quality.
Obtain up-to-date pharmacoepidemiology approach/knowledge

Quality Assurance Specialist

Global, top market share company / international atmosphere

4 - 8 million yen Shizuoka Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client is a contract manufacturer of soft capsules for pharmaceuticals and health foods.
Responsibilities: 製造・品質管理の監督
変更管理・逸脱管理・出荷管理
品質情報（顧客クレーム）対応
バリデーション・教育
製造記録・品質試験記録の照査
新規プロジェクトの推進

Medical Science Liaison (MSL) - 自己免疫領域

MSL position at global maker with strong pipeline

7 - 11 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
Responsibilities: 業務内容：
領域専門医等のリクエストに応じて、最新医学・科学情報を提供・議論する。
領域専門医等の意見、疑問、ニーズならびに共同研究などの機会を探索・収集し、社内関連部署と連携して解決策を探る。
サイエンティフックエキスパート(SE)との関係構築および維持をする。
メディカル部門主導イベント（アドバイザリーボード等）を社内医学専門家と協働して実施する。

Specialty Care Medical Affairs Lead

Medical Affairs Lead position at global mega-pharma

12 - 22 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Leadership of medical team, including setting business objectives, performance management and team development
Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas
Recruitment, development and retention of talented colleagues as well as coaching and guidance of colleagues to support them achieving their maximal potential
Membership of Medical and Commercial Leadership Teams
Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs
Ensure compliance of medical team with country Code of Practice and relevant SOPs, regulations and guidelines
Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications
Work with key external stakeholders during the life-cycle of the company's medicines, supporting the company strategy and bringing external insights to the organization to shape strategy and providing focused, relevant information in response to their needs
Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs
Ensure that product materials and related activities reflect the most up to date regulatory labelling and risk management plans and regulatory commitments
Input into regulatory submissions, clinical overviews, license variations and CDS updates as required
Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required
Input into assessment and due diligence of business development initiatives
Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio
Support for in country clinical research programs, including protocol and site feasibilities related to portfolio
Protocol approval and oversight of in country non-interventional studies related to portfolio
Support for investigator initiated research (IIR) studies to ensure that appropriate records are kept and progress is monitored
Support for media, government and patient group activities, including policy development, corporate initiatives and issues management
Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered
Accountable for medical team IIR and headcount/expenses budgets
Represent the country and countries interests to European and Global teams

Senior Brand Marketing Manager

Senior Brand Manager at global mega pharma

12 - 17 million yen Tokyo Pharmaceutical Marketing

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Specific responsibilities of the role include, but are not limited to:
Develop launch strategy, lead commercial activities for the product
Understand overall market, an environment surrounded the product and customer insights to develop robust launch strategy.
Develop tactics based on analysis obtained from data, facts, and insights, and lead commercial activities by leveraging omni-channels
Implement launch activities by leveraging internal resources and partnerships with third-party vendors, industry organizations, and, if required, other pharmaceutical companies
Keep eyes open for new information regarding company products, competitors, local and global markets, latest discussions among KOLs and academia, and legislation in Japan
Lead discussions among global/regional/local colleagues to create launch strategies for product and ensure all the cross-functional colleagues pursue the same goal
Develop revenue forecasts for the product in consistency with global and regional teams for strategies, assumptions, and models
Oversee promotional content development and marketing activities for HCPs and consumers, make sure those activities are executed in a compliant manner
Manage marketing budget and ensure related spends are completed within budget and on time.
Work with team members through coaching and mentoring;Provide the guidance and coaching to brand managers and other members in the TA as necessary to ensure their success as well as self-growth.
Create a culture and workplace environment that fosters enthusiasm, collaboration and engagements with peers and team members.
Uphold and adhere to company policies, compliance rules/regulations, SOPs, and pharmaceutical regulatory guidelines (i.e. cGMP/cGLP/cGCP).

Director: RWE Partnerships & Innovation

Director position at global mega pharma

16 - 30 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: The RWE Partnerships and Platforms organization functions to:Enhance company's ability to determine unmet medical needs;
Support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE);
Inform clinical practice on appropriate prescription and use of company products;
In collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers;
Support measurement of short- and long-term impact of company products to both patients and populations;
Support competitive differentiation.

This position will serve as the Real World Data point of contact for either one category or one geographic region.Execute on prioritized tactical plans with actionable projects, identify external partners to deliver strategic RWE capabilities / data, and oversight of high quality methods and designs to inform study / project designs for R&D franchise / asset teams, CMAO, Health Economics and Outcomes Research, Commercial and other functions’ needs
Provide daily mentorship, motivation, and guidance to more junior RWE colleagues, & direct them to co-develop emerging, core a strategic partnerships with commercial and academic data suppliers
Supports landscape assessments, new data / tool / partner due diligence assessments based on understanding evolving healthcare, technology and other industries with Customers, RWE Digital platform team, Digital RWD Enterprise Enabling Platform, RWE Biostatistics and other relevant partners
Documents all requests and track progress toward project completion, other metrics and business goals
Develops training materials for ensuring colleagues understanding and competency in various aspects of the RWE process
Communicates critical knowledge on business processes to relevant stakeholders

品質管理 (製品品質試験)

Quality position at mega pharma with strong pipeline

6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
Responsibilities: 注射剤及び固形製剤の品質管理、分析試験業務（理化学試験、微生物試験）、製品規格試験の実施及びそれに関わるverification
品質管理に係る手順、記録等の作成及び照査
逸脱・トラブルに対する調査及び問題解決策の提案・実施
変更管理
新製品導入に伴う試験法技術移管（海外本社・海外製造所と協働して実施）
部内における業務品質及び生産性改善活動
グローバル・ローカルプロジェクトのリード・参画
その他試験実施に関わる管理業務

Project Statistician

Global mega-pharma with strong pipeline

5.5 - 7 million yen Hyogo Pharmaceutical Data Management / Biostatistics

Company overview: We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
Responsibilities: Responsibilities:
The Project statistician provides strong statistical leadership in the process of drug development, develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is also responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

Other Responsibilities Include But Not Limited To The Following
Statistical Trial Design and Analysis
Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
Collaborate with data management in the planning and implementation of data quality assurance plans.
Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
Participate in peer-review work products from other statistical colleagues.

Communication of Results and Inferences
Collaborate with team members to write reports and communicate results.
Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
Respond to regulatory queries and to interact with regulators.
Therapeutic Area Knowledge
Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Statistical leadership and Teamwork
Introduce and apply innovative methodology and tools to solve critical problems.
Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

無菌注射製剤のプロセス設計・処方設計

無菌製剤開発の経験・実績がある方必見です。

8.7 - 10 million yen Shizuoka Pharmaceutical Research & Development

Company overview: We are a leading pharmaceutical company in Japan, offering a wide range of products in the medical field. Our product lineup includes various pharmaceuticals to support patient health, and we are also dedicated to research and development. We strive to develop new treatment methods and medications to contribute to the treatment and prevention of diseases. Additionally, we operate globally, providing our products to patients worldwide. We uphold high standards of quality and safety, contributing to the advancement of healthcare and the well-being of patients.
Responsibilities: 無菌注射製剤の処方設計
無菌注射製剤の治験薬並びに商用製造プロセス開発
申請業務（IND／IMPD、CTD作成および照会事項対応）
GMP製造所への製造技術移管
商用後の生産課題解決、安定生産支援、変更管理対応
製剤開発戦略の立案
導入PJにおけるパートナーとの協働
製剤の新規技術開発

バイオ医薬品の品質管理・統括業務

欧米を含む規制当局の査察・監査を経験された方必見です。

5.45 - 12.84 million yen Gunma Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: 製品分析、原料・資材管理、環境・用水・洗浄管理、微生物管理等における品質管理責任者、副品質管理責任者等
品質管理部ラボメンバーの統括管理（マネジメント）
医薬品の品質管理に関するグローバルGMP体制の整備
規制当局/協力会社に対する査察/監査対応、承認申請書の確認
バイオ医薬品の規格試験及び安定性試験の統括
分析委託先への技術移管・技術支援
製造環境、製薬用水、製造設備洗浄、工程試験（微生物）の管理戦略立案
最先端品質管理技術の導入（技術検討を含む）、バイオテクノロジーを基盤とする医薬品原薬または無菌製剤品質管理で利用されるアプリケーションシステムの立ち上げ業務およびシステムの導入後の保守改善業務

データマネジメント

データマネジメント経験が活かせます。

5.3 - 7 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is engaged in the development of pharmaceuticals and medical devices.
Responsibilities: 海外企業や、グローバルCRO、ベンダー等との窓口対応（メール・会議）
グローバル案件のDM業務担当者として、EDC仕様設計やデータクリーニングを含む業務遂行
会議参加・ファシリテーション、質疑応答、英語での資料・メール作成
チームメンバーとの協働、後輩育成

臨床企画

臨床開発のご経験をお持ちの方必見です

10 - 14.33 million yen Osaka Pharmaceutical Clinical Development

Company overview: Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
Responsibilities: 臨床企画として以下の業務をお任せします。臨床チーム（社内の専門家からなる部門横断チーム）を率いて、フェーズI～IIIの治験およびグローバルでの製品承認を進める。他社との共同開発など、比較的複雑なプロジェクトを扱う。
チームメンバーと共にプロジェクト関連の目標を設定し、必要なメンバーを要請し、リソースの利用可能性を各部門の責任者と確認する。
J-Project Team のメンバーとして臨床開発（CLD）を代表し、Launch Team のメンバーとしてもCLDを代表する。複数部門からの意見をまとめ、合意形成を行う。
関係部門と相談しながら Clinical Development Plan（CDP：臨床開発計画）を作成する。承認されたCDPに基づき、臨床タイムラインの計画と管理を行う。
グローバル戦略に沿うよう国内試験のコンセプトも提供する。
必要に応じて積極的に是正措置を行う。
日本での承認に至るまで、化合物（薬剤）のリスク・ベネフィット評価を継続的に行う。新たに入ってくる臨床データや医学・科学的情報を分析し、必要な行動や決定を行う。
CLD部門長およびグローバルクリニカルリーダーと協議しながら、医療面のプロジェクト戦略、試験結果、臨床プロジェクト結果の評価および社内外（例：規制当局）への説明を行う。主要な規制当局提出文書（J-CTD Module 2 など）の医療パートの戦略を定め、その作成を管理する。グローバルクリニカルリーダー、Clinical Science、統計、薬事、ファーマコビジランス（PHV）と協議する。
翻訳版の治験責任医師用資料（IB）の作成と管理も行う。

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