Jobs list of Medical Device & Medical Affairs / Government Affairs
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Job number: Job-00271797 Posted: 2024-06-25
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: Job-00257444 Posted: 2024-05-22
Senior Medical Affairs Manager
Unique expanding market in Japan12 - 14 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
- Main responsibilities：
Patient Advocacy & engagement for Home dialysis:
Develop relationships & drive patient advocacy for Home dialysis with key patient organization to ensure productive partnerships that build on shared patient-focused objectives
Create and execute collaboration plans with key patient groups & HCP societies based on areas of mutual interest, identify opportunities to educate and empower patient and caregivers and build innovative solutions that address relevant public health, economic and clinical issues
Lead and assist in the development of patient advocacy focused medical/scientific information resources for various media platforms and properties and monitor metrics.
Represent patient advocacy and patient perspective in relevant cross functional meetings to elevate the perspective of people living with kidney diseases and their families and advocacy organizations.
Medical Affairs Strategy & Implementation: Input to 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( Investigator Initiated studies) in close collaboration with various stakeholders towards conduct of clinical studies to generate scientific data supporting the company's therapy areas of interest
Support clinical trials for new product development through key scientific inputs & HCP engagement
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
KOL and professional society Management
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.
Linh Do
Medical Device
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