Job Description Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Johnson & Johnson is seeking an experienced candidate to lead external partnership and M&A initiatives for its MedTech business in Japan, supporting the companys innovation and growth agenda. The Director of New Business Development, Japan will
Job Purpose: クローバルメディカルライティング及び国内マトリックスチームと協働し、規制当局に提出する承認申請資料、臨床試験の関連文書等の作成をリードする。関連法規、ガイドライン及び社内規定に従い、戦略的に、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。また、効率的な文書作成プロセスを推進する。 Key Accountabilities/Responsibilities: 規制当局に提出する薬事文書の作成のリード：CTDの臨床・臨床薬理パート、対面助言資料、照会事項回答等 臨床試験に関連する文書の作成：治験実施計画書、治験総括報告書等 上記文書の作成におけるストラテジー・key messageの作成、文書作成のファシリテート、解析計画等の検討、スケジュールの作成及びCROマネジメント等 Basic Qualification: Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 社内外の関係者と円滑にコミュニケーションし、マトリックスチームをリードすることができる Global Medical Writing と協業するための英語でのコミュニケーションスキル ロジカルシンキング ダイナミックな変化のある状況下において、柔軟性・自発性をもって問題解決能力を発揮し、目標に向かって推進できる能力 臨床試験に関する基本的知識 生物統計学、薬物動態学に関する基本的知識 薬事規制、ICHガイドライン等に関する基本的知識 基本的なPCスキル（Word、Excel、PDF） Experience 製薬企業又はCROにおけるメディカルライティング業務経験（3年以上） Preferred Qualification: Skill 英文メディカルライティングスキル（治験総括報告書、治験実施計画書等） Experience 承認申請及び審査対応業務の経験（CTD作成、照会事項対応） 臨床開発業務又はそれに準ずる業務経験 複数部署の関係者で構成されるチームをリードした経験 Education/Certification/Language 薬学部または理学系学部卒以上 理学系修士または同等のもの。MD、PhD、PharmD（必須ではない）
Who we are looking for Fund accountants are primarily responsible for the timely and accurate execution and reporting of net asset valuations (NAVs) for our clients’ accounts (funds). Why this role is important to us The
Microsoft is on a mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, a theme of inspiring excellence, and encouraging teams and
PowerApps and SharePoint Developer The Opportunity: As a PowerApps Developer, you know how to harness the latest technologies by developing low-code platforms and creating user-friendly solutions for your clients. We’re looking for a solution engineer like you
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
Customer Experience Lead, CWC Tokyo Description - Job Summary As a Customer Experience Lead, you are responsible for planning and managing the customer briefings and events at the Tokyo Customer Welcome Centre. Youll work with a
About NetApp We’re forward-thinking technology people with heart. We make our own rules, drive our own opportunities, and try to approach every challenge with fresh eyes. Of course, we can’t do it alone. We know when to
Legally Necessary Hire /A Career Level - N/A - As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds. When everyone’s
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower
Work Location Type: Yokosuka, Japan As a leading industrial distributor with operations primarily in North America, Japan and the United Kingdom, We Keep The World Working® by serving more than 4.5 million customers worldwide with products
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
Company Description Work smart, have fun and make an impact! Our purpose is to guide all companies toward a sustainable world. EcoVadis is the leading provider of business sustainability ratings. Our solutions are backed by an
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Requisition #: 14233 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more
