Jobs list of Pharmaceutical

【東京/大崎】セイフティーフィジシャン（MD）～ノンラインマネージャー or グループマネージャー～

医師資格、臨床医としての経験お持ちの方必見

12 - 28 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.

Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies.
Responsibilities: ■役割と目的確かな医学的知識に基づき、この役割は委任された資産（AT）だけでなく、必要に応じて他の製品に対してもローカルの患者安全および薬物安全監視（PSPV）戦略を定義し、グローバルPSPVが提供する枠組みに基づいてクロスファンクショナルチームに利益/リスク（B/R）専門知識を提供することで、患者および/または臨床試験被験者を保護するためのBIリスク軽減戦略の一貫した実施を確保します。
LPSLと共に、ローカルの患者安全医師（PSP）は、ローカルPSPV戦略に貢献し、ローカルPSPVシステムの委任された部分を責任を持って管理することで、高品質なローカルPSPVシステムを確立および維持し、外部規制および内部プロセスに準拠することを確保します。

■責任範囲グローバルBRチームが評価し、グローバルおよびローカルで調整された利益/リスク（B/R）プロファイルの専門家として、J-RMPの準備、適切な薬物使用などの安全確保措置を講じ、エビデンス/資産チームと密接に連携してB/R知識を提供し、ローカルのニーズ/洞察をグローバルチームに提供します。日本特有の要件（例：国別形式）および内容に対応するローカルリスク管理計画の準備をリードします。
グローバルリスク最小化措置の実施と進捗を担当し、委任された資産（AT）だけでなく、必要に応じて他の製品のためのローカルRMPの開発および実施をリードします。適時かつ質の高いPV入力と洞察をローカルラベル文書および教育資料（例：SPC、PIL）に提供します。
委任された資産（AT）だけでなく、必要に応じて他の製品のためのローカル安全データの監視を実施します。BI製品または同クラスの製品に関するローカルソースから得られた関連する新しい安全情報をPVWG委員長に適時に通知します。
利害関係者（例：LRA、法務＆コンプライアンス）と協力して、ガイドラインの準備を含む適切な薬物使用などの安全確保措置の実施を促進します。
必要に応じてすべての致命的/生命を脅かすケースの医学的品質レビューを実施し、適切なフォローアップ措置を定義します。必要に応じて「致命的ケース調査」レポートを完了します。

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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【東京】ファーマコビジランスマネージャー

医薬品安全性業務の経験者必見です!

8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: 業界大手のグローバルCRO（医薬品開発業務委託機関）で、ファーマコビジランスマネージャーを募集します。仕事を通じて磨かれたチームワークの絆は深く、質の高いサービスの提供を可能にしているのも、この社員同士の絆があってこそです。さらに、社内イベントなども盛んで、ファミリーのような雰囲気が、離職率の低さを維持している秘訣となっています。日本における医薬品開発の新しいビジネスモデルを共に作りませんか？
■職務内容：
日本と中国のICSR handlingに関して、クライアントに代わりチームを管理
クライアント、他社CROと構成されるグループの良好な関係の維持
プロジェクトの問題解決とプロセス改善
チームの調整および指導（安全性評価と報告がきちんと行われるように管理）
規制要件に準拠するため、医薬品安全性戦略とプロセスを開発および実装
有害事象データを収集、確認し報告
安全管理計画とリスク軽減戦略の実施

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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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品質保証

医薬品や医療機器の品質保証部門での業務経験をお持ちの方必見です

7 - 8.5 million yen Shizuoka Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
Responsibilities: 同社は5万点以上の製品を160以上の国と地域に展開している総合医療機器メーカーです。2023年度は過去最高の売上収益・営業利益・当期利益額を更新し、売上高1兆円規模も目前に迫っています。
同社において、工場における品質保証担当を増員募集します。現在工場におけるGMP/QMSの維持管理業務のボリュームが増加しており、特に製品品質照査業務は、法的要求である医薬品だけでなく、顧客要求事項から医療機器への展開も必要となっている背景から、品質文書経験をお持ちの方をお迎えしたい考えです。独自の技術力によって各製品群で高シェア率を獲得しており、医療現場への影響力の大きい企業で、次のキャリアを築きませんか？
■業務内容：
製品品質照査（品質文書レビュー）業務：製造記録や品質試験記録から得られる管理指標が1年を通して安定しているかトレンド的な視点で評価し、報告書を作成します。
変更管理業務
文書管理業務

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【東京】MSL（未経験）

豊富なキャリアパス／研修・教育環境充実

6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: 国内トップクラスの規模とプロジェクト受託実績を誇る同社の一員となり、MSL（メデカル・サイエンス・リエゾン）としてクライアントビジネスおよび患者さんにとっての最適な治療法の確立に貢献していただきます。
MSLは、担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズ（注：未だ満たされていない医療ニーズ、有効な治療方法がない疾患に対する医療ニーズ）を収集し、育薬に貢献することが主な役割です。

具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。

[Ascent] CMC RA

CMC RA

8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
Responsibilities: Prepare documentation (including for Cartagena Type 1 Applications and CMC Consultations) with team under direction of scientific/ management lead
Interact and manage project communications with clients in bilingual environment
Support interaction with regulatory authorities

R&D Japan/ Group Manager, Innovation Management Office

Alliance / Open Innovation

8 - 16 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: All R&D communication physically such as THM and/or virtually such as via e-mail/R&D Portal site etc. R&D regular leadership communication such as RD SLT and LT.
Any R&D responsible technology-based innovation initiatives such as Robotic Process Automation, Cloud based cross functional team communication, as well as center of excellence to shard service provider at R&D. In addition to that the Group will provide service to lead non-R&D specific career development program to whole R&D, as well as to be responsible for new grads program execution.

Medical Information Specialist/Mangger

医療業界における顧客対応経験が活かせます。

6 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: （1）担当する領域の製品、開発品に関する学術的な問い合わせ（電話およびMR経由の依頼）の二次対応（製品情報センターで回答できなかった場合の対応）…文献調査、文献選定、文献内容の要約もしくは関連部署からの情報収集により回答を準備し、電話または文書にて実施（2）問い合わせ対応データから顧客のニーズを判断し、提供用のQ＆A、製品情報センターの口頭回答用のQ&Aを作成、改訂（3）担当する領域の製品に関する顧客からの要望・提案、問い合わせにより生ずるリスクに対し、リスク最小化およびビジネス最大化のための対策を講じる（4）担当製品の関連情報の提供・収集を行い、医療現場における適正使用を確保（5）販売提携などのコ・プロモーション製品においては、提携会社と円滑に情報共有が実施できる体制を構築し、両社における情報提供の整合性を確保（6）グローバルMI担当領域製品チームの一員として下記業務を実施英語での科学的な回答文書（GSRD）の作成、レビューおよびGSRDの日本向けのローカライズを実施
海外からの英語での問い合わせに対応(文書回答)する。
（7）GPT（グローバル製品チーム）に参加し、日本のマーケット状況等を共有し、グローバルとしての最適なアクション立案に貢献※専門管理職は上記に加え、マネジメント業務について相応の役割を担っていただきます。

Medical Affairs Review Specialist

Medical review

7 - 10 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
Responsibilities: 資材・スライド等の検証
社内コンプライアンス研修
部門横断プロジェクトのリード

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。

【東京】開発薬事※マネージャー候補

薬事部門のマネジメント経験者必見です!

7 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is providing drug development service.
Responsibilities: 部門の管理、人財マネジメント
営業活動
部門の予算管理
医薬品・医療機器関連の治験相談
メディカルライティング業務管理
医薬品・医療機器に関する法規制への対応業務
各国申請代理人との連絡・調整
当該国薬事規制等の調査
アジア地域における医薬品・医療機器開発戦略コンサルティング（各種試験成績・資料の評価、医薬品・医療機器承認申請に係る当局対応、申請届出等）

Senior Specialist Quality Assurance / PV Audit

Global Company

8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
Responsibilities: Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
Promotes standardization of auditing approach within QA.
May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
Provides inspection management support as appropriate.
Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.

【東京】ファーマコビジランス職（グローバルPVアフィリエート管理）※豊富なパイプライン有する製薬企業

海外駐在員としての選出も視野に入れた育成あります

6 - 11 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: ■業務内容：海外子会社（特にアジア地域）のPV業務の管理・オーバーサイト
海外子会社PV担当者と連携し、グローバル基準に準拠したローカルでのPV systemの維持・管理
海外子会社のPV組織立ち上げ・ガバナンス管理

■キャリアパス：当人の適性を踏まえ、OJTやジョブローテーション等を活用してキャリアを形成し、幹部職やマネジメント職の登用を視野に入れた育成
当人の適性を踏まえ、海外駐在員としての選出も視野に入れた育成

医薬品の品質保証

医薬品業界もしくは医療機器・食品・化粧品メーカー等類似技術を使用した業界の品質保証業務経験がある方必見です。

5 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client is a pharmaceutical manufacturer.
Responsibilities: 治験薬、医薬品のＧＭＰ、ＧＤＰ管理業務ならびに薬制対応業務
同社で扱う医薬品及び治験薬の製造・品質試験における品質保証業務全般を担当します。製造・品質試験における各プロセスの品質保証業務
逸脱管理、変更管理、CAPA管理、出荷管理
医薬品品質システムの運用推進（教育、文書管理、等）
各工場の知見集約（知識管理）とサイト横断的な医薬品品質システムの構築（共通化・効率化）
新製品や新規設備の技術移転、クオリフィケーション、バリデーション
国内外の当局GMP査察対応
業者管理（原材料サプライヤー等）

MSL(メディカル・サイエンス・リエゾン)※再生医療、オンコロジーの豊富な受託実績／年休128日

MSL・MA（メディカルアフェアーズ）経験者歓迎

6 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is providing drug development service.
Responsibilities: ■業務内容
医学的、科学的な側面から円滑なコミュニケーションを取り、KOL（Key Opinion Leader）と良好な関係を構築する。
臨床研究や製造販売後調査の立案・作成に関するサポートを行い、そのデータのPublicationを通じて製品価値を高める。
社内・外の関連部署とコミュニケーションを取り、製品ストラテジーに沿った市販後に向けた活動の企画立案。
社内外において医学的、科学的な面から自社製品の適正使用を推進する。
営業部門に対する医学教育サポートなどを行う。

[Osaka or Tokyo] Medical Writer of Drug Development

Great Company Culture

8 - 14 million yen Tokyo Pharmaceutical Research & Development

Company overview: Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.
Responsibilities: PREPARATION OF CLINICAL
TRIAL PROTOCOL- PREPARATION OF CLINICAL TRIAL SUMMARY REPORT
PREPARATION OF DRUG APPROVAL APPLICATION MATERIALS (CTD: COMMON TECHNICAL DOCUMENT) (CLINICAL PART ONLY)
PREPARATION OF INVESTIGATIONAL DRUG SUMMARY
REVIEW OF ABOVE-MENTIONED DOCUMENTS
CORRESPONDENCE BY AUTHORITIES (CLINICAL PART DOCUMENT CREATION, REVIEW, CONSULTING, ETC.)
GENERAL CONSULTING FOR DOCUMENT CREATION THAT MEETS REGULATORY REQUIREMENTS
CONTRIBUTING AS A LEADING ROLE IN THE ABOVE
APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS AND CONTRIBUTION TO MEMBER GROWTH

プロジェクトリーダー

製薬会社もしくはヘルスケア関連の研究において、創薬研究について３～４年以上の実務経験がある方必見です

9.65 - 12 million yen Kanagawa Pharmaceutical Research & Development

Company overview: Our client provides integrated drug discovery research support services.
Responsibilities: 薬効薬理部門の代表として社外や社内他部門のメンバーで構成される医薬品候補創製プロジェクトチームに参画し、顧客やステークホルダーと議論・交渉の上、試験の立案・提案・実施をリードする。(35％）
自己免疫疾患やがん免疫などの免疫研究領域における試験の研究計画立案、試験実施、データ解析、報告を関係者とのコーディネートに、主体的に取り組む。（35％）
創薬などライフサイエンス産業に応用可能で有用な新規技術や研究手法、あるいは既存の研究機能の応用が期待される未開拓領域を探索し、事業化に導く。（20%)
国内外の学会・講演会等への参加をはじめ、戦略的に社内外の研究者およびステークホルダーとのネットワークを構築し、専門領域での人的ネットワーク構築を図るなど、事業の拡大に向けた業務を担当する。(10%)

PV Manager

CROのPV部門でのご経験をお持ちの方必見です

8 - 15 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: 医薬品安全性監視部門（PV）におけるProject ManagementおよびLine Management業務全般をお任せいたします。＜具体的な業務内容＞安全性情報管理（医薬品の臨床試験・市販後）のプロジェクトマネジメント
Projectの進捗と品質、収益等の管理業務、及び、プロジェクトにおける顧客対応業務。また、他のManagerと連携し、Projectの業務計画と要員計画の立案、業務配分調整やProjectの状況の確認・評価、報告を担当いただきます。要員計画、業務配分、業務の指導など、担当するチーム（10名程度）のLine Management業務
担当するチームのスキルレベルと生産性の向上、および、働きやすい環境作りをリード。
担当するチームのメンバーと定期的なコミュニケーションを行い、パフォーマンス評価とキャリア開発。
グローバルチーム、および、提携企業と協力して、顧客との良好で強い関係を維持。

Medical Manager

Strategy planning and data gathering

13 - 17 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.
Responsibilities: STRATEGY:
Act as Local Medical Affairs TA expert in one or more TAs
Support the Brand or launch teams/ Local TA leadership team in the development of TA, Launch and Brand strategies
Lead Medical Affairs activities in assigned territory along defined local Medical Launch / Brand strategies
Consolidate and communicate trends, market insights, and unmet needs identified in the field

OPERATIONS:

Develop Medical material, review marketing material, trainings
Ensure scientific and clinical accuracy for specific product or brand
Receives adverse event reports and transmits such reports internally according to Company procedures
Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations
Maintains up-to-date GxP knowledge by following internal and external trainings
Conduct Local internal scientific training and ensure continuous Medical education of existing teams and new employees working in the Local TA
Develop Medical KTL development plans
Positively impact external perceptions and knowledge regarding company and company products
Maintain and demonstrate comprehensive and in-depth scientific TA knowledge when executing assigned tactics
Ensure operational excellence by sharing best practices
Map treatment landscape and medical environment for new indications/ programs
Provide support in the planning and tracking of the (TA-specific) medical budget

DATA GENERATION AND DISSEMINATION:

Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects
Lead Local publication process, publication dissemination and alignment with Local, Regional and Global publication plan
Act as a resource, liaison and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy
Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites
Assimilate, process and share medical information with stakeholders

STAKEHOLDER ENGAGEMENT:

Provide training to HCPs and support in realising Medical educational events
Interact with Local stakeholders in Medical community in TA
Identify and interact with influential members of the Medical community (HCPs/external experts) and other healthcare stakeholders (managed care organisations, government organisations, patient groups) within assigned territory and TA
Represent company at Medical Education events, programs, meetings and support patient advocacy related activities
Partner with external stakeholders to develop innovative solutions
Engage with internal colleagues (Medical Affairs department, Clinical Operations, Commercial colleagues as appropriate, etc.) in developing and delivering and participating in Medical or cross-functional initiatives

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