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
Asset & Wealth Management A career with Goldman Sachs Asset & Wealth Management is an opportunity to help clients across the globe realize their potential, while you discover your own. As part of one of the
Managing Director, Tokyo As Teneo continues to grow their operations across Asia Pacific, Teneo is looking for a high calibre candidate to join our Tokyo office as a Managing Director and lead client strategy and commercial
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： 臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。 業務内容： 海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。 開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う 臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理 業務全般及び組織運営にかかわる以下の活動を担う。 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成） 必要要件 Required Skill, Experience, Etc. 必要な条件Basic
Consultant, Strategy and Communications The Opportunity As Teneo continues to grow its operations in Asia-Pacific, we are looking for a high calibre candidate to join our dynamic and professional Strategy and Communications team as a Consultant
Roles & Responsibilities The Institutional Oversight team has primary responsibility for all aspects of institutional account onboarding, portfolio accounting, and serves as the single point of contact for all operations related client inquiries. These functions cover
Requisition ID 51785 Position Type FT Permanent Recruiter #LI-SS1 Posting Type LI About Kerry Kerry is the worlds leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers
About Zscaler Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange is the company’s cloud-native platform that protects thousands of customers from cyberattacks
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
JOB TITLE: FI Settlement Analyst / Associate Title: Associate Location: Tokyo, Japan Regular/Temporary: Employee Hire Impact: Enables support JGB settlement and Japan FICC business as a critical hire. Enables support delivery of OKR for FICC in
ASSET & WEALTH MANAGEMENT Bringing together traditional and alternative investments, we provide clients around the world with a dedicated partnership and focus on long-term performance. As the firm’s primary investment area, we provide investment and advisory
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
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
The global leader in public transport infrastructure, SYSTRA has specialized in the mass transit and rail market since 1957. The main shareholders of SYSTRA are SNCF and RATP. Its ambition is to serve emerging needs for collective
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
Requisition #: 14327 Internal Job Title: Technical Support Engineer Job Level: P1 Hiring Mgr: Yuichiro Hiyoshi External Job Title: Technical Support Engineer : Electromagnetics Business Unit: ANSYS Customer Excellence Recruiter: Masamichi Tanaka Our Mission: Powering Innovation
This role required candidate to permanently relocate at Dhahran, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments:
希少な栃木県内の案件です。Global企業にて人事部長をお任せいたします。 Client Details 農業・建設機器を輸入・販売する欧州系企業です。 Description -Responsible for all strategic and operational HR related topics -Leads and develops the local HR Team -Close Collaboration with the global HR team by working on global HR strategies and initiatives
