Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
It’s an amazing time to be joining Netflix as we continue to transform entertainment globally. Netflix is the worlds leading internet entertainment service with over 270 million paid memberships in over 190 countries enjoying TV series,
We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. We work directly with individuals to help them gain the skills, confidence and connections to transform their
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
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
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
Company Description Globant’s Commerce Studio helps organizations create best-in-class commerce-enabled experiences, with engineering and design at its core. The goal is to meet the demands of tomorrows customers, leveraging long-standing expertise with large and complex commerce
Eku Energy is thrilled to offer a fantastic opportunity for a Construction Manager in Japan to join our vibrant team. As a Construction Manager, you will be integral to the preparation and management of the asset
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
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,
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
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
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 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 & Durable
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 & Durable
