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
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。
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
Johnson & Johnson Innovative Medicine (JJIM) is recruiting for a(n) Quality Control Senior analyst, located in Janssen Fuji Site, Japan. This position is responsible for leading analytical method transfer for NPI to implement in country test.
Description Kenvue is currently recruiting for: Legal Entity Controller Job Description: The Legal Entity Controller role primarily oversees the legal entity (LE) financial close process , financial reporting process, ensuring the integrity and precision of the
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
At MFS, you will find a culture that supports you in doing what you do best. Our employees work together to reach better outcomes, favoring the strongest idea over the strongest individual. We put people first
Career Category Scientific Job Description Job purpose Lead and develop product medical strategy and plan based on product strategy. Key member to develop product strategy and local commercial team with brand team. Provide Japan position on
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
Intern, Forensic Investigations and Intelligence Hey Kroll superstars! Are you ready to dive into the world of Forensic Investigations with Krolls amazing team? Were on the lookout for dynamic individuals to join our Forensic Investigations Team
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job TypeFull-timeDescription Controller - This position is located at Smart Motors Toyota in Madison, WI. Relocation assistance available for the right person. Do you want to help transform the auto industry? Come let Smart Motors Toyota
Job TypeFull-timeDescription Controller - This position is located at Smart Motors Toyota in Madison, WI. Relocation assistance available for the right person. Do you want to help transform the auto industry? Come let Smart Motors Toyota
Seeking a Subject Matter Expert on regional Extended Workforce (EW) Operations via Vendor Management System (VMS). Key Responsibilities EW Request Lifecycle Management through VMS Intake of EW request from stakeholders: collaborate with CBM and GSP Country
Job TypeFull-timeDescription Controller - This position is located at Smart Motors Toyota in Madison, WI. Relocation assistance available for the right person. Do you want to help transform the auto industry? Come let Smart Motors Toyota
Job TypeFull-timeDescription Controller - This position is located at Smart Motors Toyota in Madison, WI. Relocation assistance available for the right person. Do you want to help transform the auto industry? Come let Smart Motors Toyota
The candidate will support the Legal and Compliance department to support its business across Japan, ensuring timely execution of regulatory filings, maintaining compliance registers, monitoring fund registrations, and conducting compliance checks. Responsibilities also include managing training requirements for
