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
Accepted Locations We are accepting applicants from Japan and several other countries in the region. For the full list of accepted locations, click here. This work is 100% remote. Loom Video Our Founder/CEO, Gabe Greenberg, created
Job Description Technical Services Manager (Japan) At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our
Who we are Are you looking for a dynamic career with excellent advancement potential at a global market leader? If so, consider Gartner, the worlds leading research and advisory company. Gartner delivers the technology-related insight necessary
Requisition #: 14189 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
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.
Job Description: We are looking for a seasoned security engineer to join our engineering team developing Fan Club mobile applications and platform services for our flagship hardware. We need your skills, knowledge and experiences to protect
Job Description: We are looking for a seasoned security engineer to join our engineering team developing Fan Club mobile applications and platform services for our flagship hardware. We need your skills, knowledge and experiences to protect
Key Account Sales Manager Opportunity Position: Key Account Sales Manager, Japan Location: Kawasaki, Japan The company is a leader in high precision positioning systems: Nano Positioning, Micro Positioning, Precision Motion and Automation Systems. The company’s product
Do you enjoy a role in management? Are you interested in helping to shape a new solution in Japan About our Team Elsevier Health applies innovation, facilitates insights, and helps drive more informed decision-making for our
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
About Applied Intuition Applied Intuition is a vehicle software supplier that accelerates the adoption of safe and intelligent machines worldwide. Founded in 2017, Applied Intuition provides a simulation and validation platform for various industries such as
職務 概要 Position Summary : • This Job Description applies to the position of Operational Quality Group Staff at JPKK, Fuji Plant. • This individual provides quality perspective direction for all production activities at JPKK, Fuji
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world
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
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： ・GMP/GDPに基づき、安全/品質を担保しながら、輸送/保管の倉庫オペレーションを安定的に実行できるように管理する ・Job Purpose: Manage the transportation/storage warehouse operations stably while ensuring safety/quality based on GMP/GDP. 主な業務内容： ・輸送/保管におけるQMS及びGDPガイドライン等の要求事項を遵守できるように管理する ・関連するSOP/WIの維持管理を行う ・担当業務の逸脱報告/変更管理を実施する ・3PLと合意されたKPI管理を行い、倉庫オペレーションを適切に運営する ・回収及び返品オペレーション管理 ・社内外査察対応 ※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。 Key Responsibilities: ・Manage to comply with
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
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 needs
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious
