Jobs list of Pharmaceutical & Medical Affairs

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】薬事マネージャー

治験届の作成・提出に関する経験者必見です!

10 - 12 million yen Tokyo Pharmaceutical Medical Affairs

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: 【変更の範囲：会社の定める業務】治験届書及び添付資料の作成、維持・管理に関連する業務
規制当局（PMDA、MHLW等）との各種相談業務
承認申請関連業務（クライアント様への申請業務サポート）
薬事情報の収集、維持・管理に関する業務
部下の人事管理
その他（各種会議・研修等への参加）

【大阪】薬事マネージャー

治験届の作成・提出に関する経験者必見です!

10 - 12 million yen Kansai Pharmaceutical Medical Affairs

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: 【変更の範囲：会社の定める業務】治験届書及び添付資料の作成、維持・管理に関連する業務
規制当局（PMDA、MHLW等）との各種相談業務
承認申請関連業務（クライアント様への申請業務サポート）
薬事情報の収集、維持・管理に関する業務
部下の人事管理
その他（各種会議・研修等への参加）

エビデンスジェネレーション

製薬企業、CROまたは研究機関において、5年以上のスタディマネジメント経験をお持ちの方必見です。

7 - 11 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: 企業主導で行う研究プロジェクトにおいて、研究プロジェクトマネジメントを行い、計画に則ったエビデンス創出に貢献する。
研究者及びその所属研究機関、米国本社、社内関連部門（メディカルアフェアーズ、研究開発本部、法務・コンプライアンス部門など）との協働により、研究者の独立性・研究の中立性を保ちながら、研究者主導研究支援のオペレーションを管理・実行し、日本の研究者による革新的なエビデンスの創出を支援する。

薬事 (スペシャリスト ~ マネージャー)

治験届の作成・提出に関する経験をお持ちの方必見です。

8 - 10 million yen Tokyo Pharmaceutical Medical Affairs

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: 治験届書及び添付資料の作成、維持・管理に関連する業務
規制当局（PMDA、MHLW等）との各種相談業務
承認申請関連業務（クライアント様への申請業務サポート）
薬事情報の収集、維持・管理に関する業務
その他（各種会議・研修等への参加）

Medical Science Liaison (MSL) - 糖尿病領域

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: 職務内容/Job Responsibilities担当疾患領域（糖尿病／循環器疾患）の専門家として病態や治療薬に関する深い知識を背景に、領域専門医等からの医学・科学的な疑問点やニーズに対応することにより、患者さんの病状改善やＱＯＬ向上に貢献する。また領域専門医等との議論を通じて得た意見やニーズを社内関係部署に還元し、製品価値の最大化に貢献する。

主な職責/Primary responsibilities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）/ソートリーダー(TL)との関係構築並びに良好な関係維持を行う。

薬事スペシャリスト (Osaka)

新薬の承認申請（CMC、非臨床、臨床）に関する薬事経験をお持ちの方必見です。

8 - 10 million yen Kansai Pharmaceutical Medical Affairs

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: 治験届書及び添付資料の作成、維持・管理に関連する業務
規制当局（PMDA、MHLW等）との各種相談業務
承認申請関連業務（クライアント様への申請業務サポート）
薬事情報の収集、維持・管理に関する業務
その他（各種会議・研修等への参加）

メディカルアドバイザー（免疫領域）／グループマネージャー

ライフサイエンス分野（理系）がバックグラウンドの方必見

8 - 11.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a pharmaceutical company dedicated to developing medical products that make substantial contributions to healthcare through comprehensive research and development efforts. As a privately held entity, we focus on strategic research and development, free from the influence of shareholders\' interests, ensuring stable long-term growth. Additionally, we prioritize talent development, providing our employees with various growth opportunities. Renowned for our "no layoffs" management approach, we are committed to nurturing talent on a global scale.
Responsibilities: ■業務内容詳細：配属部署では，すでに上市した薬剤に加え，複数のパイプラインを有しております。そのため，開発段階から上市後まで幅広くメディカル活動をリードするMA（Medical Advisor）を必要としています。グローバル戦略に沿い，複数の部署を横断するチームメンバーと協働しながら，エビデンス構築，専門家からのインサイトに基づくアンメットメディカルニーズの特定，アドバイザリーボード会議等の企画立案を責任者として担う役割です。この中で、日本の意見はグローバルの戦略に組み込まれますので、非常にやりがいのある仕事です。また、ドイツ本社メンバーとの国際会議や海外学会への参加など、海外のステークホルダーとのコミュニケーションも役割の一つです。国内における免疫領域のアンメットメディカルニーズを理解し，臨床研究の基本的な知識とプロジェクトを適切にマネージする能力，また他部署とのコラボレーションや外部専門家（External Experts）とのコミュニケーション，アドバイザリーボード会議や承認後の薬剤の価値最大化・適正使用に必要なメディカル戦略も検討していく長期的な視野を持った人材を求めています。また、ピープルマネージャーとして、タレントマネージメントの一環として、メンバーのキャリアプランを作成し、コーチングを含む必要なサポートを提供します。さらに、マーケティング部門などと組織横断的なコラボレーションを率先し、実践いただきます。

■責任：グローバルの開発戦略、メディカルプランニングを日本のrepresentativeとしてグローバルと密に協業しながら共に作成、実行する
日本のニーズに合わせたマーケット部門との協働でのGlobal Integrated Asset Plan（IAP）に沿ったIntegratedCustomerPlan（ICP）の作成
グローバルの開発戦略や顧客からのインサイト、アンメットニーズに沿ったメディカル戦略・戦術の作成と実行を内外のステークホルダーとともに計画し実行する

医薬品安全性メディカルドクター

基礎研究の経験が活かせます。

10 - 15 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: 医薬品の個別症例の安全性情報のメディカルレビュー
医薬品の安全性管理計画とリスク最小化計画の立案と実行
規制当局への申請書類の作成
社内および海外関係会社との安全性関連会議での医学的観点からの貢献
医療従事者などの社外関係者との科学的な議論をリードする
臨床開発チームと密に連携し、安全性と医学的観点から医薬品開発をサポートする
医薬安全性担当者のトレーニングと人材育成への貢献

開発薬事コンサルタント

開発薬事業務,クリニカルモニタリング業務,プロジェクトマネージャー業務,メディカルライティング業務等5年以上の方必見です

8.1 - 9.5 million yen Kansai Pharmaceutical Medical Affairs

Company overview: We specialize in supporting new drug development. Our fundamental philosophy is to consistently provide professional quality in all aspects of pharmaceutical development and to pursue the happiness of our stakeholders, including pharmaceutical companies, medical institutions, patients, shareholders, and employees. Founded by nine members who previously worked on new drug development at a major domestic pharmaceutical company, we leverage our extensive experience in developing drugs such as immunosuppressants to support the entire new drug development process. Currently, in response to the pharmaceutical industry\'s increasing reliance on outsourcing, we have established a system centered around highly knowledgeable and capable CRAs to provide fast and accurate data. Additionally, we have built a global support system for new drug development, using our Japan office as a hub to facilitate international joint clinical trials across Asia, Europe, and the United States. We also place a strong emphasis on employee education, continually enhancing our training systems to ensure ongoing skill development.
Responsibilities: 依頼者から提供される情報を元に、依頼者が考える日本での開発戦略と日本の薬事規制のギャップを分析し、リスク評価、代案や薬事パスウェイ等の提案を中心になって、あるいは中心者をサポートしてレポートにまとめる。（ギャップ分析）
依頼者の開発品の臨床試験開始に向けて、品質、非臨床試験、臨床試験等に関するPMDAとの事前面談や対面助言を計画し、依頼者から提供された資料を基に必要資料を中心になって、あるいは中心者をサポートして作成し、PMDA相談を実施する。
治験届に必要なドキュメントを中心になって、あるいは中心者をサポートして作成し、PMDAへ治験届を提出する。
PMDAからの照会事項に対する回答書を依頼者と相談しながら作成し、提出する。
治験国内管理人業務の一部を、チームの一員として行う。

【東京】プロジェクトマネジメント／メディカル・サイエンスアフェアーズ

医療機器および/または医薬品開発の実績がある方歓迎

5 - 11 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
Responsibilities: ■職務内容：【変更の範囲：会社の定める業務】
MSA（Medical and Scientific Affairs）部門は、最終顧客である患者がどのような医療機器やサービスを求めているのかを把握するとともに、自社の事業部門に伝えて製品開発や営業活動に反映させつつ各国の規制当局への対応も行うなど幅広い役割を担っています。これらの中でも「臨床試験（Clinical Research）」「医療経済学の研究（Healthcare Economics）」「メディカルアフェアーズ（Medical Affairs）」「専門職教育（Professional Education）」「メディカルセーフティ（Medical Safety）」の5つの機能を重視しています。
【業務詳細】
GI BUのプロダクトマネージャーとR＆D PMOのプロジェクトマネージャーと協力してプロジェクトを理解、全体像を把握し、CERなどと協力してMSAがそのプロジェクトにどのように貢献すべきかを把握します。その情報をR＆D PMOとGIビジネスユニットへ共有することで、地域PMOとプロダクトマネジメント、そしてMSAの他のメンバーとのインターフェースを保ちます。MSAリーダーシップの承認を得たプロセス改善イニシアティブを推進・支援
専門家と協力してプロジェクトの範囲と目的を決定し文書化
目標達成に必要なリソースを予測し、効率的に管理
MSA全体のリソース管理を支援し、施行
作業範囲とリソース要件に基づいて予算を準備し、コストを追跡
詳細なプロジェクトスケジュールと作業計画を開発・管理
ステークホルダーに定期的にプロジェクトの更新情報を提供
ベンダーやサプライヤーとの契約を管理し、成果物を確認
業界のベストプラクティスを採用し、プロジェクト実行を改善
リスク管理とプロジェクトのパフォーマンス測定を行う
ビジネスニーズとリソースに応じてグローバルプロジェクトの優先順位を設定
プロセスの実現可能性と効果を評価し、変更を推奨
プロセス文書を作成し、必要に応じて修正
その他、割り当てられた機能イニシアティブ/ビジネスニーズを処理

【未経験者歓迎】MSL<オンコロジー領域>

薬剤師資格をお持ちの方必見です

5 - 6.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
Responsibilities: クライアント製薬企業でのMSL業務に携わります。MSLとは医師に対して、医学・科学的なエビデンスや高度な専門知識をもとに、医薬品の情報提供を支援する職種です。開発メンバーやMRと協力をして、医師へのアプローチやディスカッションする等の非常にやりがいのあるお仕事です。
仕事内容:主にKOL（キーオピニオンリーダー）のマネジメントや臨床研究支援になりますが、具体的には以下です。学術トピックスの提供、新薬の情報提供。
医師主導研究への対応
地区スピーカー育成
適用外使用等の情報提供

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）

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.

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: We are part of a global pharmaceutical company, providing specialized products and services in the medical and health fields. We primarily research, develop, manufacture, and market pharmaceuticals, contributing to the treatment and prevention of disease. Based on innovative medical technologies and scientific approaches, we conduct advanced research and development to bring new treatments and pharmaceuticals to the market. We also develop educational activities and support programs for healthcare professionals and patients, contributing to the improvement of the quality of healthcare. Leveraging our global network, we respond to the needs of diverse regions and markets and promote sustainable medical innovation.
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.

R&D Japan/ Group Manager, Innovation Management Office

Alliance / Open Innovation

8 - 16 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are part of a global pharmaceutical company, providing specialized products and services in the medical and health fields. We primarily research, develop, manufacture, and market pharmaceuticals, contributing to the treatment and prevention of disease. Based on innovative medical technologies and scientific approaches, we conduct advanced research and development to bring new treatments and pharmaceuticals to the market. We also develop educational activities and support programs for healthcare professionals and patients, contributing to the improvement of the quality of healthcare. Leveraging our global network, we respond to the needs of diverse regions and markets and promote sustainable medical innovation.
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.

Hematology MSL

7 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are part of a global pharmaceutical company, providing specialized products and services in the medical and health fields. We primarily research, develop, manufacture, and market pharmaceuticals, contributing to the treatment and prevention of disease. Based on innovative medical technologies and scientific approaches, we conduct advanced research and development to bring new treatments and pharmaceuticals to the market. We also develop educational activities and support programs for healthcare professionals and patients, contributing to the improvement of the quality of healthcare. Leveraging our global network, we respond to the needs of diverse regions and markets and promote sustainable medical innovation.
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。

開発薬事担当

グローバルトップシェア／福利厚生や休暇制度も充実

6 - 11 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: ■職務内容：グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築規制当局（厚生労働省、独立行政法人医薬品医療機器総合機構など）との窓口業務承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理）

■カルチャー／環境について：パイプラインに恵まれており、また外資の中では比較的穏やかな社風なので、じっくりキャリアを積むのには良い環境となっております。副業も認められており、ジョブポスティング制度によるキャリア形成も充実しております。フラットでスピーディーな組織体制となるべくアジャイル組織を導入するなど、働き方への変化へ非常に前向きな企業でございます。

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】MSL（メディカルサイエンスリエゾン）

主にKOLのマネジメントや臨床研究を支援

6 - 8 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
Responsibilities: 学術トピックスの提供、新薬の情報提供。
医師主導研究への対応
地区スピーカー育成
適用外使用等の情報提供

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