Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題（役割分担等）の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題／問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する知識がある方 Experience 企業での業務経験のある方（分析、製造、CMC薬事、開発等）（3年以上が望ましい） Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why
The Customer Project Execution department is responsible for the overall execution of the Wind Farm from delivery of components, BOP Electrical & Civil Works, Installation & Commissioning works and testing, up to handing over of the Wind
Are you interested in joining a strong performing sales team? Westlaw Japan is expanding its contents business and looking for a new Business Development Manager to develop its portfolio within the Small to Medium Business segment. Westlaw Japan
Job purpose: Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with Brand Lead to develop and
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
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL
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The Technical Sales Management department is the regional arm of our global Technical Sales Organisation, which links our Business Unit and our customer needs towards the central Power Solutions Team, responsible for the global Product Development in
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious goals,
Company Description Overview: To support the set-up and delivery of retail projects and programmes from initial feasibility stage through to design, procurement, construction, and successful handover. You will be a project manager representing the end user
Job Purpose: His/her mission is to work closely with the business stakeholders and lead the process in defining, answering business questions and implementing innovative solutions arising from business questions that can be answered with analytics/AI. Through
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
JOB SUMMARY The Marketing and Communications Manager is part of an important team that creates and executes property-level communications to our customers. Under the leadership of the Director of Marketing and Communication, this role promotes on-brand
Coty is one of the world’s largest beauty companies with an iconic portfolio of brands across fragrance, color cosmetics, skincare, and body care. COTY is the global leader in fragrance and number three in color cosmetics.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Secure our Nation, Ignite your Future ManTech is seeking a Field Technician (CI/HUMINT) to join our team in our USMC customer in Okinawa Japan, This position requires an ACTIVE DoD TS/ SCI Security Clearance. ManTech International
About the Role: Grade Level (for internal use): 13 Department overview: Sales specialist is a key function within S&P Global with responsibility for client-facing activity including all aspects of business development for its specialist product line and region.
SENIOR SALES MANAGER LUXURY, JAPAN Coty is one of the world’s largest beauty companies with an iconic portfolio of brands across fragrance, color cosmetics, skincare, and body care. COTY is the global leader in fragrance and
Work Flexibility: Hybrid or Onsite Position summary: Work as part of the Network Services Integration team to deliver network infrastructure projects in line with identified requirements. Work with key stakeholders to ensure that all deliverables are
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 ※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。 必要要件 Required Skill, Experience, Etc.
