We are seeking intern colleagues who can start from Late-August for APCO Tokyo office. Brief APCO Worldwide is an independent and majority women-owned business with over 30 offices in major business, financial, political, and media capitals
Johnson & Johnson is the worlds most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices and
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Job title: Regulatory Affairs Manager Thermo Fisher Scientific Inc. is seeking a highly motivated individual to join our world-class team as a Regulatory Affairs Manager in Japan. As a global leader
Job Description: Note: This position will be seconded to Rakuten Edy Co., Ltd. upon joining the company. Mission Our mission is to support the sustainable growth of Rakuten Payments diverse payment services and provide advanced fintech
Job Description Wise has already pioneered new ways for people to transfer money across borders and currencies. Our customers can also manage their hard-earned money with the world’s first platform to offer true multi-currency banking. The
JOB DESCRIPTION: MAIN PURPOSE OF ROLE • Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs. • Ability to execute highly complex or specialized projects. • Adapts precedent and may make significant
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, andsolutions are personal. Through
ERM Digital Services is seeking a Senior Consultant to join our global sustainability company. This role is within our APAC business unit and will be based in Japan, preferably in Tokyo. At ERM, we offer a
Join us. Let’s care for tomorrow. At Allianz Global Investors we foster a culture of professionalism, fulfilment, and an inclusive working environment. Do you want to be part of a leading active asset management company? Then
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
【Job Responsibility】 Highly skilled and high potential leader with a proven track record of delivering results in progressive roles to join our team. Have the opportunity to shape and drive a sustainable and high-performing financial accounting
Job Purpose Responsible for the leadership and operational management of all Quality Assurance, Quality Control, Incoming Materials and External Quality in Japan supply chain, to ensure the continuous supply of medicines & vaccines in line with
Join us today and make a difference in peoples lives! The Marketing Manager/Product Manager Neuromodulation is truly a Business Development Partner, expected to partner with our customers who are Neurosurgeon and Neurology. The incumbent will have
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise
Case Processing Staff Japan YOUR TASKS AND RESPONSIBILITIES: Promptly and accurately identify, interpret and extract adverse event and all relevant corresponding case information from a wide variety of source documents Enter the extracted information into the
職務の目的 開発品目の承認申請時の添付文書案作成等： 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 市販品目の添付文書管理： 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 アートワーク管理： 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。 市販後薬事： 市販品目のライフサイクルマネジメント（主にCMCの変更管理）に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。 主な業務内容 承認申請資料（添付文書案含む）の作成・改訂 承認申請時の添付文書案作成における取りまとめ 承認審査時の添付文書関連照会事項に対する回答作成 添付文書改訂相談における当局窓口 添付文書改訂版の校正 添付文書の届出 PMDA 公開サイトの企業ページ管理・必要情報の登録・公開 添付文書に係る外部問合せに対する回答 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開 市販品目の変更管理に関する薬事業務 業許可管理の業務 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定 業界団体・学術団体等を通じた薬制に関する規制調和の推進 ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント 必要な条件 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験 海外とメール又は口頭でコミュニケーションができる英語力 当局関係者と交渉するためのコミュニケーション能力 基本的なITスキル（Word, Excel, Power Point等） 向上心があり、変革に対して前向きであること
Product Manager – Quantile (Post Trade Solutions) Quantile brings a proven, unique blend of business, quantitative and technology skills to the industry, to provide post-trade risk reduction services to major derivative market participants. Our focus is
Job purpose: Responsible for driving commercial success of Botox business in Japan. Member of the GSK/Abbie cross-functional shaping global strategy and co-creation Key responsibilities: Understand global strategy and initiatives, as well as local environment and insights
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Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of
