Position Purpose: Quality Assurance Senior Associate – Japan 日常の品質案件（市場への出荷の決定、逸脱処理、品質情報処理、変更管理）をグローバルCSLB社の基準や本邦の規制に沿って適切に遂行する To operate appropriately routine quality events (market release, deviation, complaint and change)in compliance with internal / global CSLB policies and local regulatory requirements 社内の他部門（営業本部、マーケティング本部、メディカル本部、薬事部、製造サイトなど）との連携 To collaborate with
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team at Novo
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a Medical Scientific
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a Medical Scientific
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 The Role: Genmab is looking for an experienced and dedicated Clinical Research Scientist to be part of our Medical (not medical affairs) team. This position is based in our Tokyo office. As Clinical Research Scientist you will be
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team at Novo
JOB DESCRIPTION: Job Summary: Lead adverse event (AE) reporting job including maintenance of pharmacovigilance (PV) information technology (IT) system. Ensure compliance with local regulations and Abbott Policy/standard operating procedures (SOPs). ROLE & RESPONSIBILITIES 1. Ensure compliance
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team at Novo
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a Medical Scientific
Are you a strategic leader with a commercial mindset? Are you interested in driving market access strategies for life-changing products and services? We are looking for a dedicated Local Market Access Senior Group Manager to join
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team at Novo
Obtaining and maintaining regulatory approvals from the Ministry of Health, Labour and Welfare to market ophthalmology-specific medical devices, pharmaceuticals and quasi-drugs in Japan. [Strengths] The role will provide a wide range of knowledge and experience in regulatory
Work Flexibility: Hybrid or Onsite The Jobs Mission 弊社は、日本で最初に単回使用医療機器の再製造事業を開始したマーケットリーダーです。新製品の承認取得や償還価格設定などの薬事業務やその他関連業務を通じて、再製造単回使用医療機器（R-SUD）の正しい理解を促進し、日本におけるR-SUDの迅速な普及に貢献することを期待します。 Key Activities & Accountabilities 当社が製造販売する再製造単回使用医療機器に関する薬事業務を行っていただきます。 製造販売承認の取得 海外製造元に日本の要求事項をインプットし、協力して申請方針を立案 PMDA対面助言 試験の計画作成 資料収集及び申請書作成 照会対応など 承認の維持管理業務 変更管理 QMS定期更新 QMS適合性調査申請 海外製造元に日本の要求事項をインプットする 調査申請に必要な資料を収集、調査申請書作成・提出、照会対応 原則実地調査のため、必要に応じて海外製造所、製造販売業者及び国内製造所の調査をサポート 保険収載業務 新規に保険償還を取得する製品の保険適用希望書を関連部署と協働で作成 厚生労働省との折衝 ヒアリングや中医協への対応 その他 販促物のレビュー また、社外・社内関係者とのコミュニケーションを通して、R-SUDの普及を目指していただきます。 厚生労働省やPMDAと協働し、R-SUDを正しく、かつ迅速に普及するための活動を行う。 海外及び国内のストライカーメンバーと良好な協力関係を築き、R-SUDの日本市場への導入を促進する。
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
This is what you will do: The Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the medical and scientific objectives of Alexion’s product/s across the product/s life cycle. He/she is a peer scientific expert
JOB DESCRIPTION Job Title: Quality Assurance Manager Department / Cost Center: External Quality / 687 Reports to (Job Title): Associate Director, In Market Quality Job Code: Location: Japan office Date Prepared: 01AUG2024 SUMMARY DESCRIPTION State the
ROLE SUMMARY The International Medical Communications & Content (MCC) team is part of the Global Medical Engagement and Impact (MEI) platform within the Global Chief Medical Affairs (CMAO) Office. The International MCC team drives local medical channel content strategy across the
JOB DESCRIPTION: 1) Main Purpose of Role Develop and execute strategic plans, programs and stories that deliver high impact results focused across 5 key areas: Storytelling, Media Relationships, Proactively Managing Issues, Engaging Employees, and Driving /
Job Title RA Senior Manager - JP IGTD RA Lead Job Description Regulatory Affairs Senior Manager Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world
