Jobs list of Pharmaceutical & Medical Affairs

Hematology MSL

7 - 12 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: 血液疾患領域において自社のメディカルポジション(世評、信用)の確立。
自社製品並びに関連疾患領域に関する最新の医学・医科学情報を提供。
HCPから依頼があった場合に限り、未承認薬・適応外薬等に関する情報を提供。
メディカルアフェアーズプランで言及されるメディカル戦略に従い活動。
メディカルアフェアーズの疾患領域チームで合意したKOLリストを基に個々のKOLに対し計画を立て活動。
HCPとのコミュニケーションを通じてメディカルニーズの収集と評価を行い、インサイトの探索ならびにメディカルアフェアーズプランの策定および更新に貢献。
企業主導型臨床研究の実施支援、および医師主導型臨床研究関する助言・支援。
メディカルエデュケーションプログラムおよびアドバイザリーボードの実施支援。
医薬情報担当者への研修の支援。

【東京】RA Consultant

医薬品の開発、承認申請に関わった経験5年以上お持ちの方必見です。

6 - 9 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: RAコンサルタントとして下記業務をお任せいたします。臨床開発戦略立案コンサルタント
ギャップ分析
医薬品総合機構との対面助言サポート
オーファン指定申請サポート
承認申請サポート等

製薬メーカーでの内勤サポート <オフィスメディカル>

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: <業務内容＞
オフィスメディカルは、メディカルアフェアーズ機能の内勤職として、医療現場における『アンメットメディカルニーズを把握』し、把握したニーズを充足することにより医療上の価値を最適化するための『メディカルプラン』に基づいて『エビデンスを創出』すると共に、創出したエビデンスを含む医学・科学的情報を『適切に発信、提供』を行う役割を担っていただきます。
業務内容は役割により多岐に渡りますが、代表的な業務内容を下記に記載いたします。
オフィスメディカルには「メディカルアドバイザー」「サイエンスコミュニケーションズ」「メディカルインフォメーション」と呼ばれる職種が該当します。

メディカルプランの作成
アドバイザリーボードの立案/実行
メディカルイベントの企画/実施
資材作成やスライドレビュー業務
パブリケーション戦略、メディカルエデュケーション企画実施
医療従事者や社内 MR、患者様からの取扱製品に関する問い合わせ対応
メディカルインフォメーション（2 次対応）
最新医学情報の収集と社内関連部署への提供
グローバル関連部署との折衝やコミュニケーション
関連業務のサポート全般（書類等の作成、確認、保管、発送業務等）

■研修体制：
同社の豊富な実績やデータ、ネットワークをもとにヘルスケアの基礎から、営業・マーケティング、臨床、データ・テクノロジー、マネジメント・リーダーシップ、経営など、これからの医療・ヘルスケアの担い手に求められる多様なプログラムが体系化されています。MSL専門プログラムも用意されており、基礎から応用、実践まで対応可能です。

Medical Affairs PM

Medical PM

8 - 14 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: 1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
For US headquarters-led research, work with headquarters personnel to promote the project.

2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.

[Tokyo] Medical Science Liaison in Diabetes

Rich Pipeline and Expanding

5 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a global healthcare company.
Responsibilities: Identifies, lists and communicates with KOLs and HCPs in the practice setting (e.g., academic centres, investigators, IISs research site) to update their understanding of relevant data in each context related to products, as well as to build and maintain relationships to facilitate scientific exchange on topics of relevance to company.
Assists in identifying, engaging, and maintaining relations with KOLs and HCPs to establish and/or further the knowledge of products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.
Assists in identifying and responding to inquiries from KOLs and HCPs; assisting with identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest.
Gathers Medical insights regarding company and competitors’ products from KOLs and HCPs to help inform company decision-making bodies and update the Medical and/or Marketing Strategies if necessary.
Participates in assigned medical and scientific meetings to maintain awareness of current issues and new data pertaining to company and competitors’ products and to support medical booth in answering physicians’ scientific questions.
Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical Strategy.
Assists regional Medical Representatives (MRs) in handling scientific and clinical questions for company marketed products from KOLs and HCPs.
Support the on boarding of new MSLs where required.
Support clinical trials by driving scientific discussion at site selection and site initiation visits where required.
Support scientific dialogue with investigators at prioritized/requested sites and patient recruitment and retention of subjects where required.
Participates in a series of internal medical/scientific trainings and regular scientific assessments to maintain general scientific knowledge and awareness of new data pertaining to company and competitors’ products.
Complies with all guidelines, policies, legal, regulatory, and compliance requirements.

メディカルアフェアーズ本部　肺高血圧症疾患領域スペシャリスト

6 - 10 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: Responsible to develop the Medical Affairs product strategy through the analysis of medical needs collected from all internal & external stakeholders of the therapeutic area
Responsible for managing MAF study / publication portfolio in alignment with brand strategy
Responsible for people and operational budget management of PH (Pulmonary Hypertension) therapeutic area
Day to day project management for activities based on the Medical Affairs Plan in responsible disease areas
Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC (Healthcare Compliance) rules.

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。

薬事戦略立案

米国の医薬品薬事の実務経験をお持ちの方必見です

5 - 10 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is an infusion solution manufacturer.
Responsibilities: （1）米国の医療機器の開発から承認（承認変更維持管理を含む）に係る薬事全般業務・薬事戦略立案、FDA相談、FDA申請／承認、医療保険対応など（2）米国の医療機器の薬事制度等の情報収集、教育 ※以下の薬事業務を行う場合もある。（3）米国の医薬品の開発から承認（承認変更維持管理）に係る薬事全般業務（4）日本の医薬品、医療機器等の開発から承認までに係る薬事全般業務薬事戦略立案
当局相談（相談提案、相談資料のレビュー、相談申込、相談対応）
承認申請業務（申請資料のレビュー、申請作業、照会事項対応）
保険収載

MSL

アカデミア出身者歓迎です!

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: KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集・主催、共催の講演会企画の立案、実行ならびに他部門の支援
医療従事者からの非臨床、臨床研究等の相談対応
Data generation plan の策定と戦略達成に必要なデータギャップの特定・パブリケーションプランの作成

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。

薬制薬事担者

製薬、医療機器業界における薬制・薬事業務の経験が活かせます。

7 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: 許可等業者の法令遵守体制の維持・管理（手順書作成・運用、会議体事務局、GQP/GVP部門との連携等）
国内および海外子会社における製品リスク（回収、偽造医薬品等）への対応
医薬品（再生医療等製品等新規モダリティ含む）及び医療機器の開発・上市に向けた薬事規制に関連する調査、社内連携のリード
社内における薬機法等の薬事規制に関する疑義照会対応業務
海外での医薬品販売承認維持のための薬制業務及びプロジェクトマネジメント業務
国内外の規制当局との授受文書の管理業務
国内及び海外当局等から発出される各種薬事規制の収集・分析・社内への適用推進業務
GMP/QMS/GCTP適合性調査（承認前調査/定期調査）、外国製造業者認定の維持・管理業務
製造委託先への製造・試験法に関する調査等（承認書と製造実態の整合性に係る年次点検、日局改正対応状況の確認等）

オンコロジー領域MSL

乳がん、消化器がん、肺がん、血液がん領域のいずれかの領域でのMSL経験が活かせます。

6 - 11 million yen Tokyo Pharmaceutical Medical Affairs

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: KEEとの科学的交流の推進
Medical Educationの企画・実行
社内でのインサイト共有と、メディカル戦略立案への貢献

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

【東京】導入候補品の探索、評価およびビジネス交渉

事業開発／ライセンス業務経験が活かせます。

5 - 7 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a pharmaceutical manufacturer.
Responsibilities: 導入候補品の探索、評価およびビジネス交渉をお任せいたします。
導入候補品の探索、評価およびビジネス交渉（医薬品）
導出プログラムの紹介およびビジネス交渉
社内会議体への提案資料の作成
経験の浅い社員への業務サポートおよび指導（管理職候補）

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。

【東京／8月以降入社】MSL（血液領域）～豊富なキャリアパス／研修・教育環境充実～

血液領域における経験ある方歓迎

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: 業務内容：
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。
【具体的役割】
KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集
主催、共催の講演会企画の立案、実行ならびに他部門の支援
医療従事者からの非臨床、臨床研究等の相談対応
Data generation plan の策定と戦略達成に必要なデータギャップの特定
パブリケーションプランの作成

【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）

薬事

薬事関連（国内・海外）法規制対応経験をお持ちの方必見です。

6.1 - 6.3 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client sells, manufactures, exports and imports medical devices.
Responsibilities: 薬事関連（国内・海外）法規制対応
営業部門及び国内外現地代理人との交渉
体外診断薬医薬品（IVD）ビジネスの法的業務推進及び薬事登録に必要なドキュメントの作成
体外診断薬の国内品質業務対応

Jobs list of Pharmaceutical & Medical Affairs

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