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 to
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） 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。
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
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
At Fiskars Group we are unified and driven by our common purpose: pioneering design to make the everyday extraordinary. Join our team and seize the extraordinary opportunity to influence the everyday! GENERAL ACCOUNTABILITIES: • Maintaining accounts
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Position summary: The Recruiter will be responsible for managing the talent acquisition process for J&J Japan Innovation Medicine (Pharmaceutical). The Recruiter will manage the recruitment life cycle activities including but not limited to: sourcing, pre-screening, interviewing,
Description 【Position Summary】 The position represent RGM (Revenue Growth Management) and provides analysis, insights and recommendation to decision makers to maximize GTS / NTS / GP growth for KENVUE and the retailers. Provide and maintain IT
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
About SmartNews SmartNews is a global leader in redefining information and news discovery, committed to providing users with accurate, timely information and supporting quality journalism. We combine the power of our unique machine-learning technology with the
Job Description Overview We are seeking a skilled and experienced Site Reliability Engineer to join our team. In this role, you will be part of the AI & Cloud Engineering (ACE) Division and AI Workbench team.
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 to
Join us today and make a difference in peoples lives! ・Prepare and provide effective training programs both for LivaNova CP sales team and customers ・Assess the findings through the scientific/clinical study and support Marketing team how
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
Accountable for the quality, consistency and production of the specialty restaurant kitchen. Exhibits culinary talents by personally performing tasks while leading the staff and managing all food related functions. Coordinates menus, purchasing, staffing and food preparation
•Position Purpose •Develop and deliver strategies to give our company customer facing teams a competitive edge with personalized engagement as well as data-driven insights using advanced commercial processes, systems and tools •Key Responsibility Areas •Establish the strategic direction
Johnson & Johnson is recruiting for a TS ASPAC SD/Logistics J&J internal consultant leader in Japan to be the technical lead for the upcoming SAP S/4 Hana Transformation initiative from 2023. This Supply Chain Digitalization program
Position Purpose Develop and implement the business strategy for the HEM product portfolio, with both short-term and long-term business objectives. Oversee and lead all marketing and sales plans to achieve the business objectives within policies and
JD in Japanese follows. 英文の後に和文JDをご覧いただけます。 Introduction Circulate all forms of value to unleash the potential in all people What can I do to help society thrive with the finite resources we have? The Mercari marketplace app
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
