Position Purpose The role is closely embedded with the therapeutic area focused business units supporting the development and implementation of robust communication and public affairs strategies that drive the business objectives of the Janssen business and
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’
職種 正社員 職務明細 As a PR Manager of Fendi Japan, the main mission is to proactively support PR & Communication Manager in driving branding and business through innovative and tactical PR and event activities. スキル・資格 •
Job Description Summary -Provide timely & professional ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Mgmt. Ensure consistently
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。
Airbnb was born in 2007 when two Hosts welcomed three guests to their San Francisco home, and has since grown to over 4 million Hosts who have welcomed more than 1 billion guest arrivals in almost
Let’s be #BrilliantTogether Overview: We are seeking a Research Associate to join our Governance Research Team for Korean Market to deliver excellent corporate governance research the helps investors manage their governance opportunities and risks . Responsibilities:
Job Description Date Revised: 08APR2024 Business Title: Assistant Accountant Job Role Title: Assistant Accountant Reporting To: Accounting Manager Job Code: Salary Grade: (as required by country) NA: Salary Classification: (as required by country) NA: About US
The era of pervasive AI has arrived. In this era, organizations will use generative AI to unlock hidden value in their data, accelerate processes, reduce costs, drive efficiency and innovation to fundamentally transform their businesses and
Who we are is what we do. Deel and our family of growing companies are made up of global teams dedicated to helping businesses hire anyone, anywhere, easily. The team comprises over three thousand self-driven individuals
Campari Group today is a major player in the global branded spirits industry, with a portfolio of over 50 premium and super premium brands, marketed and distributed in over 190 markets around the world, with leading
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new
Position Name: Travel Consultant Location: Chuo-ku, Tokyo Work visa: Required Who we are: BCD Travel helps companies travel smart and achieve more. We drive program adoption, cost savings and talent retention through digital experiences that simplify
Work Flexibility: Hybrid The Jobs Mission Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks. マネジャー、リードスペシャリストの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。 Key Activities
