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）
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 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
Location: Shiodome Division: SHISEIDO Global Brand Unit Job level: Group Manager Reports to: VP Contract type: Full-time Job Summary: This position leads the Shiseido Global Communications team developing, budgeting, implementing, ideating, and executing all global influencer
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
Location: Shiodome Division: SHISEIDO Global Brand Unit Job level: Group Manager Reports to: VP Contract type: Full-time Job Summary: This position leads the Shiseido Global Communications team developing, budgeting, implementing, ideating, and executing all global influencer
Location: Shiodome Division: SHISEIDO Global Brand Unit Job level: Group Manager Reports to: VP Contract type: Full-time Job Summary: This position leads the Shiseido Global Communications team developing, budgeting, implementing, ideating, and executing all global influencer
Who are we? Equinix is the world’s digital infrastructure company®, operating over 250data centers across the globe. Digital leaders harness Equinixs trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
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
Summary Posted: May 2, 2024 Weekly Hours: 37.5 Role Number: 200549947 You know what it takes to encourage a team to create an incredible customer experience with every interaction. You’re a role model and leader who
POSITION SUMMARY Process all guest check-ins, check-outs, room assignments, and room change/late check-out requests. Secure payment; activate/reissue room keys. Ensure rates match market codes, document exceptions. Verify/adjust billing for guests. Communicate to appropriate staff when guests
POSITION SUMMARY Promote awareness of brand image internally and externally. Use sales techniques that maximize revenue while maintaining existing guest loyalty to Marriott. Communicate with potential owners via telephone to set up preview package sales/tours. Encourage
Human Resources Coordinator Create and maintain filing systems. Create and type office correspondence using a computer. Distribute and route mail. Order and track Human Resources office supplies and forms. Answer phone calls and record messages. Create new
COMPANY OVERVIEW Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment
Company Description How do you feel about a clean slate? The power to start Business Development activities your own way with the support and technology of a market leading company with you? If that sounds like
Company Description Wolt is a technology company that makes it incredibly easy to discover and get the best restaurants, grocery stores and other local shops delivered to your home or office. Since launching 7 years ago,
As the Azure SMB Partner Marketing Lead for Japan, you will be responsible for Defining, developing and executing partner marketing strategies to ensure market, channel, partner readiness for new solution/offering launch. Designs, executes, and localizes end-to-end
Manager, Japan Community and Public Affairs Come make possible a better future by joining the Applied Materials’ Japan Communications team. Applied is the leader in materials engineering solutions, which are used to produce virtually every new
JOB SUMMARY Provides a high level of property maintenance knowledge. Position has overall responsibility for maintaining the building, grounds and physical plant with particular attention towards safety, security and asset protection. Accountable for managing the budget,
