Jobs list of Medical Device & Medical Affairs / Government Affairs
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NEWJob number: JN -012025-182869 Posted: 2025-02-07
Medical Affairs Manager / Leading manufacturer of blood and peritoneal dialysis
-0 - 0 million yen - Medical Device Medical Affairs / Government Affairs
- Company overview
- We are an international healthcare company engaged in the development, manufacturing, and sales of medical products. We believe that everyone should have the opportunity to live a healthy life free from disease and full of possibilities. To achieve this vision, we dedicate ourselves fully each day to promoting innovation and providing smarter, more personalized healthcare solutions. We partner with healthcare professionals in hospital settings such as patient rooms, operating rooms, and intensive care units, as well as in dialysis facilities and patients\' homes. Our goal is to enhance treatment efficiency, improve access to care, prevent complications, and ultimately improve patient outcomes. We strive to deliver a range of better products that also consider healthcare economics, ensuring that we contribute positively to both medical treatment and economic aspects.
- Responsibilities
The leading manufacturer of blood and peritoneal dialysis is seeking a candidate to engage and develop Key Opinion Leaders (KOLs) in scientific activities and establish the organization as a leader in science-driven healthcare.
The company is addressing a critical need in the dialysis treatment landscape, where 95% of patients currently rely on hemodialysis, which requires them to visit a healthcare facility three times a week. With peritoneal dialysis (PD) offering a groundbreaking home-based alternative, the company is uniquely positioned as the only provider of products for both treatment modalities, with a 70% market share in PD. As the prevalence of kidney disease continues to rise, this role offers the opportunity to make a significant contribution to expanding treatment options for dialysis patients.
They are looking for a talented individual to drive evidence generation and enhance the credibility of peritoneal dialysis in the marketplace, particularly as clinical results suggest it may be less harmful to the kidneys than hemodialysis. Medical Affairs Manager will play a critical role in gathering and synthesizing clinical data to expand treatment options and encourage hospitals that have traditionally focused on hemodialysis to adopt peritoneal dialysis. While prior experience in nephrology is not required, expertise in evidence generation is essential to effectively communicate new treatment options to physicians, ultimately benefiting patients and advancing healthcare solutions.
■Key responsibilities:
Developing clinical education initiatives in collaboration with national societies.
Providing medical content to marketing teams to ensure effective therapy related communication.
Educating healthcare professionals on the safe use of renal products and therapies for chronic peritoneal dialysis (PD) and hemodialysis (HD).
Support product launches and implement medical plans aligned with commercial strategies.
Serve as the primary scientific expert and support the therapy team in customer engagements.
Build relationships with KOLs to increase awareness and promote safe product use.
Collaborate on special projects within the therapeutic area, including medical affairs and CME.
Review promotional materials for compliance with regulatory and scientific standards.
Provide training and serve as a subject matter expert.
Drive the generation of clinical data to support therapies and maximize commercial opportunities based on customer insights.
The ideal candidate will drive innovation by integrating customer feedback into strategic planning while maintaining a strong understanding of the therapy landscape.
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Elaine Montes
Medical Device -
NEWJob number: JN -112024-179545 Posted: 2025-02-07
Head of MSA
Work on impactful and meaningful work20 - 30 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- Our client imports and sells allergy and autoimmune diagnostic solutions.
- Responsibilities
- Main responsibilities:
Lead and develop the Japan Medical and Scientific Affairs team to ensure strong alliances and consistency of medical and scientific strategies worldwide.
Conduct and manage clinical studies, from design through execution and analysis, aimed at supporting new product launches in partnership with marketing and QA&RA departments.
Establish medical and scientific evidence that proves the clinical advantages of our products.
Drive clinical needs for new product development in Japan and collaborate in related clinical studies.
Translate scientific data into actionable insights for customers and other departments based on proven professional expertise.
Establish and maintain solid relationships with internal teams and Key Opinion Leaders (KOLs) to improve the company's presence in the Japanese medical and scientific communities.
Gather insights from KOLs and field presence to inform the organization about trends and opportunities in allergy and autoimmunity.
Craft and deliver medical and scientific training to further develop organizational capability within Japan.
Manage and develop the MSA Japan team with integrity, emotional intelligence, and inclusion.
Stay updated on medical and scientific expertise across the product pipeline from development through commercialization.
Represent the division at national and international conferences, contributing to symposia and encouraging education and adoption efforts.
Offer clinical expertise and strategic mentorship for the development of medical and scientific strategy and business initiatives.
Support compliance and ensure product safety in all interactions.
Go Ozawa
Medical Device -
NEWJob number: JN -012025-183183 Posted: 2025-02-07
MSL (Diabetes) / Global medical device manufacturer with a dominant market share
-8 - 12 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.
- Responsibilities
- 【未来の糖尿病患者を救う革新的なソリューションを拡大するMSL募集/世界で100年以上続くグローバル医療メーカー】
低侵襲かつ持続的測定を可能とした自己血糖測定器で圧倒的なシェアを誇るグローバル医療メーカーで、メディカルサイエンスリエゾン(MSL)を募集しています。
長年の実績より専門医から厚い信頼を得ていますが、糖尿病患者が増え続ける中、早期診断を実現し、より多くの命を救うためには、専門医以外の認知度向上が不可欠であると考えています。
オンリーワンとも言える特徴あるプロダクトをもつ企業で、共に医療の発展を追求し、患者様の未来を救う機会がここにあります。
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Risa Harada
Medical Device -
Job number: JN -112024-180613 Posted: 2025-01-24
メディカルアフェアーズ(学術)担当者
周囲を巻き込みながら課題を解決していける方がベストマッチ6 - 9 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- We are engaged in the medical field, specializing in clinical diagnostics. As a leading company in the industry, we provide valuable technologies and biomarker products. Our mission is to create new value in the healthcare market and contribute to the future of health and medicine. Since successfully commercializing products such as the syphilis test kit "Syphilis HA Antigen (TPHA)," we have been involved in research, development, manufacturing, and marketing, bringing innovation to the global clinical diagnostics industry. Particularly as a leading company in the field of immune sera, we have significantly contributed to medical advancement through the development of highly sensitive automated immunoassay instruments and dedicated reagents, as well as the development of rapid immunodiagnostic kits. We have garnered worldwide attention by swiftly succeeding in the development of a rapid antigen test kit for the novel coronavirus (SARS-CoV-2), demonstrating our commitment to providing highly socially impactful and necessary products.
- Responsibilities
- 今回募集するポジションでは、学術担当として、当社製品における学術的な情報を社内外にお届けする業務を行って頂きます。弊社製品の導入先医療施設のご協力の元、自社製品である機器・試薬の性能評価や適用拡大の可能性についてデータ(=クリニカルエビデンス)を収集・分析します。集めたデータを基に、お客様へは勉強会等を通じて製品に関する最新の学術情報の共有、社内では、主に研究開発部門へ対して、外部評価のフィードバックや製品改良のための情報共有を行います。将来的には学術担当として専門性を高めていく他、プロダクトマネージャーへのキャリアパスや社内公募制度を活用したグループ企業内での横断的なキャリア形成も可能です。
業務内容:
自社製品である機器・試薬に関する最新の学術情報を顧客へ提供するための一連の業務(性能評価等のデータや文献からの情報収集・分析、資料作成および勉強会等の実施)
製品開発、改良に必要な外部評価等の情報やデータの収集・解析およびR&D部門へのフィードバック
グループ販売会社との協働による製品導入サポート業務
Risa Harada
Medical Device -
Job number: JN -072024-169751 Posted: 2024-09-11
メディカルアフェアーズ
プログラム医療機器のメディカルアフェアーズ7 - 11 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- Our client is a Japanese AI solutions company specializing in the healthcare sector. With expertise in medical data analysis and advanced AI algorithm development, they are dedicated to addressing key challenges in the healthcare field. Their solutions contribute to optimizing diagnostic support, treatment planning, and overall healthcare efficiency. Much of their investments go into the development of AI solutions for health-related applications, encompassing areas such as patient monitoring, predictive analytics, and overall health management/support.
- Responsibilities
- AI(医療機器プログラム)製品の開発、承認、臨床戦略、保険加算獲得、販売促進に関わるアクティビティのリードをお任せします。将来的には臨床開発、メディカルライティング、QC、統計解析等の役割の異なるメンバーを臨床開発マネージャーとして率いて頂く可能性もあります。ご経験や適性に応じて、以下を中心とした業務に従事していただきます。
業務内容:
臨床戦略の立案・実行
薬事承認目的、もしくは製品販売後の臨床試験の立案・実行・管理
論文、学会発表、各種データベース等を活用した他社製品との差別化、販売促進のためのエビデンス構築
マーケティングツール(One pager、Value Brief、White Paper等)の作成
マーケティングツールを営業部門が活用するためにトレーニングの実施
AI製品の保険収載プレミアム加算獲得のための臨床・保険戦略の立案と実行
AI製品の保険収載プレミアム加算獲得のための臨床試験の実行・管理
薬事申請業務のサポート(STED / CSR / CER等の作成、作成サポート、文書QCチェック、GMP / QMS適合性調査信頼性調査サポート、等)
Go Ozawa
Medical Device -
Job number: JN -082024-173626 Posted: 2024-09-11
Medical Affairs Manager
腎症に詳しい元医療従事者の方必見です10 - 13 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- We are an international healthcare company engaged in the development, manufacturing, and sales of medical products. We believe that everyone should have the opportunity to live a healthy life free from disease and full of possibilities. To achieve this vision, we dedicate ourselves fully each day to promoting innovation and providing smarter, more personalized healthcare solutions. We partner with healthcare professionals in hospital settings such as patient rooms, operating rooms, and intensive care units, as well as in dialysis facilities and patients\' homes. Our goal is to enhance treatment efficiency, improve access to care, prevent complications, and ultimately improve patient outcomes. We strive to deliver a range of better products that also consider healthcare economics, ensuring that we contribute positively to both medical treatment and economic aspects.
- Responsibilities
- Establish medical affairs as strategic partner to business by developing therapy area strategic goals and execution plans in active partnership with local, regional and global marketing and medical to support yearly and long term plans for business strategy and goals To ensure compliance for all medical affairs related activities with ethics and integrity Building & enhancing the scientific image of the company (internal & external)
Main responsibilities:
KOL and professional society ManagementDevelop, nurture and engage KOLs and professional scientific societies in scientific exchange activities that differentiate the company as a scientifically driven healthcare organization. Represent the company medical affairs to external stake holders.
Medical Affairs Strategy & Implementation Develop Medical affairs strategy related to pre-launch, launch and post launch activities: conceptualize and implement Medical plan in unison with commercial strategy) to support improving patient outcomes
Establish evidence generation plan in close collaboration with various stakeholders towards conduct of clinical studies to generate scientific data supporting the company's therapy areas of interest
Develop High Impact Clinical education( non-promotional education) and voice of customer( advisory boards) initiatives in close collaboration with National societies
Work closely in a cross-functional approach with the therapy unit to identify the unmet needs and bring voice of customer to the table cultivating innovation – medical advisory boards
Develop Digital education initiatives: webinars, digital education contents on therapy
Cross functional insights & support:With marketing team: Design/provide medical insights for the Marketing team and strategize dissemination of therapy-related communication to support brand management
With regional teams: Effectively interface with the regional and global team to ensure optimal implementation of regional & global initiatives.
With Market access teams: Effectively interface with market access to provide subject matter expertise that enables resolution of market access and funding issues. This includes working closely with the Market Access team in designing and implementing the HEOR studies/data.
With commercial excellence: Therapy training to commercial team
With business development team: provides insights towards medical due diligence activities
Compliance:Review of promotional material & material for submission to regulatory authorities
Provide therapy training to the commercial colleagues.
Shotaro Tsubaki
Medical Device
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