Serves as a senior compliance risk analyst for Independent Compliance Risk Management (ICRM) responsible for establishing internal strategies, policies, procedures, processes, and programs to prevent violations of law, rule, or regulation and design and deliver a
Be part of one of the top largest global diagnostics companies in the industry. Lead in RA activities for the business to obtain product approval/maintenance. Client Details * One of the largest diagnostics and life science
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter
This is a great opportunity to be a part of the Real Estate Asset Management Company Secretarial team Job Summary: As a Company Secretarial Analyst you will be responsible for supporting the Asia Pacific Real Estate
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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。
Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in drug development, NDA
At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric
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
Who we are and what we do Telexistence develops remote-controlled robots with artificial intelligence, with the mission to change robots, the structure, and the world. Gathered by highly expert professionals worldwide, the engineering team consistently develops
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At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric
(English follows) 【部署の説明】 ファイナンシャルコントロール&マネージメント部は主に、会計、財務・規制報告、税務、経費管理、支払業務、管理会計、経営報告、企画・分析に関する事項を担っています。 当ポジションは、会計・財務報告チームのメンバーとして、主に以下の業務をご担当頂きます。 (1) 会計要件に従ったタイムリーかつ正確な仕訳作成・入力 (2) 財務諸表および規制当局への報告資料の作成 (例: 金融庁、生命保険協会)・報告 (3) 税務申告関連資料 (国および地方) の作成・報告 (4) 財務報告に係る内部統制に則った業務の実施 (5) 財務分析、それに伴う経営陣向け報告書の作成、報告 【職務内容】 主に次に挙げる業務をご担当いただきます。 ■会計業務 ・他部署・他チームからの問い合わせ対応(取引に使用する勘定科目、消費税区分、源泉税の取扱い等) ■決算関連業務 ・月次/四半期/年次決算作成及びチームマネージャーのサポート ・JGAAP および IFRS の期末決算処理 ・補助元帳と総勘定元帳の照合 ・税務当局の監査、外部会計監査人からの問い合わせや資料請求の対応・サポート ■レポーティング業務 ・JGAAP および IFRS ベースの財務情報に関する報告書作成
At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric
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.
Our Impact Tax Division analyzes and supports the activities, operations, reporting obligations and transactions of the firm’s business lines to ensure that tax consequences and reputational risks are evaluated appropriately. Tax Analytics and Control team sits
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
Who we are looking for The Head of Compliance in Japan will provide compliance advisory support as the second line of defense to the Japan office of State Street Global Advisors. The individual will be reporting
Career Category Regulatory Job Description Group Purpose Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities
At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric