Job Description Responsibilities Functionally responsible and accountable for the following areas: Facilities management for 6 facilities in Japan Repairs, maintenance, improvement Access/badge management Office supplies, mail service Office layout, design, planning, seat assignments On-site Contingent Worker
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
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
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
About Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For
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
Position Description: The Partner Account Manager (PAM) participates in a virtual account team-selling environment, managing a partner eco-system within a geographic region. Their focus will be fostering key partnerships that are committed to driving both recurring and
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： 臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。 業務内容： 海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。 開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う 臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理 業務全般及び組織運営にかかわる以下の活動を担う。 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成 ※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。 必要要件 Required Skill, Experience, Etc.
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL
Job Purpose: His/her mission is to work closely with the business stakeholders and lead the process in defining, answering business questions and implementing innovative solutions arising from business questions that can be answered with analytics/AI. Through
Job purpose: Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK
Requisition #: 14356 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
Grade: G4 Vacancy no.: DC/TOKYO/GS/2024/01 Publication date: 16/04/2024 Application deadline (midnight Tokyo time): 30/04/2024 Job ID: 11886 Department: ILO-Tokyo Organization Unit: ILO-Tokyo Location: Tokyo Contract type: Fixed Term Contract duration: 12 months (renewable) Under article 4.2,
Grade: NOA Vacancy no.: DC/TOKYO/NO/2024/01 Publication date: 16/04/2024 Application deadline (midnight Tokyo time): 30/04/2024 Job ID: 11885 Department: ILO-Tokyo Organization Unit: ILO-Tokyo Location: Tokyo Contract type: Fixed Term Contract duration: 12 months (Renewable) Under article 4.2,
Fender Musical Instruments Corporation is a world famous brand with offices across the globe. An American icon, Fender was born in Southern California and has built a worldwide influence extending beyond the studio and the stage.
Requisition #: 14225 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 than 50 years, Ansys software has enabled innovators
Service Department Vestas Asia Pacific provides both sales and service of wind power plants in Australia, New Zealand, India, China, Japan, Korea, Taiwan, Philippines and the emerging markets in North South East Asia (NSEA). In the
Location: Japan (Tokyo) Role Overview: In this vital role, you will develop and drive hi-touch sales engagements into major telecom carriers in Japan. Your focus will be to create and implement strategic account plans to attain
