Minimum qualifications: Bachelors degree or equivalent practical experience. 4 years of experience in business development, partnerships, management consulting, or investment banking, in the consumer electronics, auto, OEMs, telecom, e-commerce/retail, apps, ads, gaming, or technology industries. Experience
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 200,000 businesses worldwide – including Brex, Rippling, Navan, Qantas,
About Klook We are a leading pan-regional experiences platform in Asia Pacific, purpose built to digitalize experiences and make them accessible to every traveler. Our mission is to build the digital infrastructure for the global experience
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
The Apex Group was established in Bermuda in 2003 and is now one of the world’s largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Responsibility: 変更提案に対する薬事影響評価(変更カテゴリ―、必要なデータ)の特定 市販製品(低分子医薬品及び/又はバイオ医薬品)の変更管理における薬事的なリスク低減策を含むCMC薬事戦略の立案・実行支援 薬事アクション(一変・軽変・相談・照会回答)に供する高品質な資料の適時作成 海外関連部署に対する本邦規制要件の提示・解説 (担当マネージャー)チーム成果物(提案・資料等)の品質保証(整合性、適切性) Role: 製造所の変更提案に対し適時薬事影響評価を行う。 市販製品の薬事アクション(一変・軽変・相談・照会回答)に対し、提言、方針策定の支援、海外を含む関連部署との交渉を行う。 薬事アクション(一変・軽変・相談・照会回答)に供する資料につき、海外薬事を含む国内外の品質部門と協働して資料作成を行う。 他部署との協業上の問題(役割分担等)の解決・調整を支援し、プロセス改善に寄与する、あるいはその提言を行う。 (担当マネージャー) チームメンバーの上記活動に対する能力開発を含めた指導・支援を行う。 関連部署との個別の課題/問題につき、必要な調整・解決のための協議を行う。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification スキル Skill 分析化学、製剤・薬剤学・プロセス工学(特に製造方法あるいはGMP)等に関する知識 品質に関わる国内規制、各種ガイドライン及び日本薬局方などの知識 ロジカルシンキング(論理的に物事を整理し、本質を見極められる) 他者との緊密な協力関係を構築し、協業できること Word、Excel、PowerPoint、Outlook、 経験 Experience CMC関連業務(分析、製造、QA、CMC薬事など、関連業務5年以上が望ましい) CMC薬事経験必須、スタッフは関連業務経験の有無により以下を考慮することがある - 変更管理業務を含むCMC薬事への興味の高さ・習得意志の強さ - 業務に利用可能な傑出したスキル(例:英語がnative levelなど)またはコンピテンシー(自己認知・成熟性、変革行動、顧客志向性など)を1つ以上有する 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上
We are a global team of innovators and pioneers dedicated to shaping the future of observability. At New Relic, we build an intelligent platform that empowers companies to thrive in an AI-first world by giving them
Position SummaryYou will lead health technology assessment (HTA) and evidence synthesis activities to support access and reimbursement in Japan. You will work with cross-functional colleagues in market access, clinical development, regulatory, and global HEOR teams. We
Company Description Omio’s vision is to enable people to travel seamlessly anywhere, anyway. We are bringing all global transport into a single distribution system and creating end-to-end magical consumer journeys. With Omio you can compare and
Minimum qualifications: Bachelors degree or equivalent practical experience. 4 years of experience in a sales role in the enterprise software or cloud space. Experience selling to clients in the enterprise cybersecurity or IT field. Ability to
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Job Description Specialty Care Commercial Strategy and Operation (Associate Director/Senior Specialist) Our company is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that improve and save lives. We are seeking
職務の目的および主な業務内容 主に下記の業務を担当いただきます 。 事務サポート業務内容 -チーム内および社外との会議調整 -資材審査のサポート(承認申請対応のみ。コンテンツの作成・修正は対象外) -社内外ステークホルダーへの対応(メール対応) ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件 スキル Microsoft Outlook/PowerPoint/Word/Excelを用いた基本的な業務経験 社内外ステークホルダー対応(事務連絡・調整)の経験力 業務を主体的にリードいただける方 学位/資格/語学力 学位不問 望ましい条件 スキル Content Lab(社内システム)を用いた資材審査プロセスの対応経験※未経験の場合でも、配属後に業務を通じて習得可能経験 経験 製薬会社での業務経験 学位/資格/語学力 学士号(ビジネス/医学関連/関連分野) 日本語ビジネスレベル以上 Why GSK? Uniting science, technology and talent to get ahead of
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing
About Klook We are a leading pan-regional experiences platform in Asia Pacific, purpose built to digitalize experiences and make them accessible to every traveler. Our mission is to build the digital infrastructure for the global experience