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.
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
Location(s): Japan City/Cities: Tokyo Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: April 17, 2024 Shift: Job Description Summary: Focus, Scope, & Impact: The HR Director, People & Culture is responsible, in
【職種】運用管理・保守 *＊Systems Administrator - Windows案件＊基本リモート＊* ＜期間限定でお仕事されたい方 必見です＞ ＜セキュリティ運用の経験を活かせます＞ ご応募お待ちしております！ 【Systems Administrator - Windows 】 保険向け運用支援業務。 保険会社様向けの以下の作業をお願いします。 1.定常作業、計画作業、依頼作業、障害・問い合わせ対応。 2.不定期・イベント作業 課題対応、イベント対応 POC作業ドキュメント作成支援。 中央本線（東日本） 立川 徒歩5分（立川市／最寄り駅：立川駅） 09:00〜18:00 24/365 実働8時間 休憩60分 残業は10〜30(時間/月)です。 【派遣先について】 ソフトウェア会社でのお仕事です。 【たばこ：禁煙】 業種：IT・通信・Web関連 【派遣会社】株式会社スタッフサービス ITソリューションブロック スタッフの福利厚生を担当する専門セクションを設け、きめ細やかな対応を心がけております。 ●各種社会保険完備(労働者災害補償、健康保険、厚生年金保険、雇用保険) ●有給休暇 ●定期健康診断 ●eラーニング、通信教育などの研修制度...
Work towards The Green Transition. Vestas Global Procurement is one of the leading Procurement organizations and is overall responsible for all strategic Procurement activities within Vestas Wind System. Supplier Account Management, Negotiations, cost out initiatives, Category Strategy
Job Title Account Manager, IS Responsibilities – Prospecting, Account management and development - Analyze the local travel market and source leads for prospecting. - Convert leads and manage opportunities according to the Amadeus sales process until
JOB SUMMARY Responsible for maximizing revenue and profit associated with rooms and function space in participating cluster properties. Position is accountable for preparing forecasts, budgets and projections, as well as pricing, positioning and inventory management. Oversees
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every day,
Its fun to work in a company where people truly BELIEVE in what theyre doing! Were committed to bringing passion and customer focus to the business. The Role Proofpoint, Inc. is seeking a self-starting highly motivated sales
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
Company Description LinkedIn is the world’s largest professional network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting opportunities, build necessary skills, and gain
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to
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
Coupa makes companies operate smarter and grow faster. Our leading AI-driven platform connects and optimizes sourcing, purchasing, supply chains, and financial management. More than 3,000 global organizations large and small trust Coupa to transform operating margins,
Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies—from the world’s largest enterprises to the most ambitious startups—use Stripe to accept payments, grow their revenue, and accelerate new business
Location： Shiodome Division： People Division Job level： Manager Reports to： Group Manager Contract type： Full-time Roles & Responsibilities（業務内容） Job Summary: Responsible for managing and maintaining the HR data center of excellence, ensuring the accuracy, integrity, and
Coupa makes companies operate smarter and grow faster. Our leading AI-driven platform connects and optimizes sourcing, purchasing, supply chains, and financial management. More than 3,000 global organizations large and small trust Coupa to transform operating margins,
Company Description NIQ GFK is a global measurement and data analytics company that provides the most complete and trusted view available of consumers and markets worldwide. We provide consumer packaged goods manufacturers/fast-moving consumer goods, Tech &
