Requisition #: 14370 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
This position is responsible for leading media buying and executing communication activities to increase brand awareness and gain audiences’ understanding of the maison. In consistency with international brand direction as well as local business objectives, plan
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 理学系修士または同等のもの。MD、PhD、PharmD（必須ではない）
CSQ325R49 As a Big Data Resident Solutions Architect (RSA) in our Professional Services team you will work with clients on short to medium term customer engagements on their big data challenges using the Databricks platform. You
Job Requisition ID # 24WD76945 Position Overview Were looking for an experienced communications partner who is ready to take on an exciting challenge. You will be part of a global team of Communications professionals supporting the
About the Company Cybereason is on a mission to reverse the adversary advantage by empowering defenders with ingenuity and technology to end cyber attacks. We have the technology, and now we are looking to expand our
Would you like to be a part of a content team focused on the medical industry? Want to take your nursing experience and knowledge to the next level of publishing? About our Team Elsevier is a
Our Team CSR Export is part of SCP (supply Chain Planning) department, and it will work closely with Production Planners and Logistics Operation. In summary, you will be the window person from Manufacturing Plant and find
Company Description Since we opened our doors in 2009, the world of commerce has evolved immensely, and so has Square. After enabling anyone to take payments and never miss a sale, we saw sellers stymied by
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 SUMMARY Responsible for soliciting and managing of reservations sales-related opportunities. Manages and provides training and work assignments to Reservations Sales staff. Actively up-sells each business opportunity to maximize revenue opportunity. Achieves personal and team related
Requisition #: 14370 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
Mapbox - Technical Support Engineer Mapbox is the leading real-time location platform for a new generation of location-aware businesses. Mapbox is the only platform that equips organizations with the full set of tools to power the
Senior Site Reliability Engineer-AWS Are you an Engineer looking for an interesting and inspiring opportunity? Are you passionate about being part of a successful team? Join the Team Baker Hughes has a new opportunity for Senior
Who we are looking for The Alpha Portfolio Services team is a dedicated global business team working with Clients, SSC IT, client service, and the business operations teams to ensure accurate end-to-end oversight of Front office
ABOUT THE JOB Research and collect the best representative images from websites, studios, distributors, vendors, screen captures, and related sources in a timely and accurate manner for entry into an internal database. RESPONSIBILITIES Follow established standards
Minimum qualifications: Bachelors degree or equivalent practical experience. 7 years of experience in low-level software engineering (e.g., memory allocators, performance optimization, C++, operation systems). 2 years of experience in people management. Preferred qualifications: Masters degree or
Job Description Lead the functional safety requirement definition and its management for the semiconductor products (i.e., MCU, SoC and A&P product) for automotive which require ISO 26262 compliance. You can work with global members. 1. Functional
Niantic is seeking Software Engineers to help build next-generation augmented reality and location-based games using Niantic’s Real World Platform. The ideal candidate has a love for games and the ability to collaborate with Unity developers, technical
JOB SUMMARY This position works closely with Market Director of Revenue Strategy, General Managers and shared service revenue team to ensure proper strategies are in place to optimize total hotel revenue, including pricing strategy, mix management,
