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
You will report to the Office Manager and support multiple consulting professionals. Responsibilities include coordinating deadlines, analyzing, and handling sensitive information, and playing a critical role in handling confidential information requests. Client Details Global consulting firm
You will be in charge of covering day to day administrative support to several team members and manage, and general office management support for the Tokyo office. Client Details Our client is one of the top
This Global Business Analytics platform has continued to be a leader on the Gartner Magic Quadrant for 10+ years in a row. With cloud-based and on-premise versions, this platform is highly flexible providing features such as Big
You will be a part of the finance and operations team of a financial services company performing corporate accounting duties. You will mainly be tasked with accounts payable, expense processing, and support for preparation of financial
* Lead and manage a team of biostatisticians and data managers to ensure the delivery of high-quality and timely statistical analysis plans, data management plans, and data analyses for clinical trials. Client Details * Our client
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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
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【Responsibilities】: Play an important role in capturing/understanding existing business process and implement successful AI Solutions that make an impact on the process Responsible for bridging the gap between IT and the business, developing the business case, capturing requirements, and
【Responsibilities】: Play an important role in capturing/understanding existing business process and implement successful AI Solutions that make an impact on the process Responsible for bridging the gap between IT and the business, developing the business case, capturing requirements, and
【Responsibilities】: Envision, build, deploy and operationalize an end-to-end machine learning (ML) and AI pipeline Build a robust enterprise wide architecture for AI and collaborate with data scientists, data engineers, developers, operations and security Perform the following
【Responsibilities】: Play an important role in capturing/understanding existing business process and implement successful AI Solutions that make an impact on the process Responsible for bridging the gap between IT and the business, developing the business case, capturing requirements, and
