About Us At Cloudflare, we are on a mission to help build a better Internet. Today the company runs one of the world’s largest networks that powers millions of websites and other Internet properties for customers
Just Global: At Just Global we live and breathe B2B and believe in igniting B2B relationships. Our independent, global team actively engages with clients to put our deep technical knowledge and unique perspectives of markets and
Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
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
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
Is now the right time for you to take your administration and business support experience to the next level? We are looking for someone who is passionate about their work, loves to be in a dynamic
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Finance Job Details About Salesforce We’re Salesforce, the Customer Company,
About Us At Cloudflare, we have our eyes set on an ambitious goal: to help build a better Internet. Today the company runs one of the world’s largest networks that powers approximately 25 million Internet properties,
Kraken Technologies is a company within Octopus Energy Group who are licensing the Kraken software platform and operating model to clients. Current clients are both the Octopus Energy Retail businesses around the world as well as
Coach is a global fashion house founded in New York in 1941. Inspired by the vision of Creative Director Stuart Vevers and the inclusive and courageous spirit of our hometown, we make beautiful things, crafted to
企業概要 IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be their
Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
About the role: We are looking for an exceptional person to join us as a Senior Account Manager as a member of our growing media sales team in Tokyo and help Brightcove achieve breakout growth. This
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
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
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Customer Success Job Details About Salesforce We’re Salesforce, the Customer
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
