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
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
F&B Manager Job Description JOB SUMMARY Position responsible for all the food and beverage operations, which includes all culinary, restaurant, beverage and room service operations. Oversees guest and employee satisfaction, maintaining standards and meeting or exceeding
PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effective dialysis therapy for patients under the direct supervision of a licensed nurse in accordance with organization policies, procedures, and
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
JOB SUMMARY Assists in successfully planning, developing, implementing, and evaluating of the quality of property’s rooms. The position ensures Rooms Operations meet the brand’s standards and targets customer needs. Strives to continually improve guest and employee
Job Description SummaryJob Overview With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site
This role involves coordinating schedules, handling appointments, and managing documents for two executives in the Human Resources Management Department. The position requires strong organisational skills and proficiency in office software. Client Details This global innovation company empowers people
2nd largest is in IT services, consulting and business solutions company that has been helping the worlds leading companies on their transformation journeys for more than 50 years. Based on consulting, we offer a comprehensive range
An exceptional Human Resources Business Partner who will play a pivotal role in driving business success. It is an exciting opportunity for you to thrive in a dynamic and collaborative environment, where you can make a significant impact
As an HRBP, you will be responsible for one of the companys cor business units. You will be flexibly devising human resources strategies while overseeing aspects such as personnel systems, talent development, performance management, succession planning and employee
DESCRIPTION Overview This role is for an EHS Manager, Safety Specialist or Safety Engineer. The roles prime responsibility will be to support the safety operations in Tokyo, Japan. As well as this, there may be opportunities
Job brief Our client is an AI-driven technology company that embodies the concept of beauty and is advancing the digital transformation of the beauty industry through SaaS services. Japan has a well-developed beauty and cosmetics market,
会社概要 弊社のクライアントは世界的に有名な建設機械メーカーです。 幅広いクレーン製品を取り扱い、世界のクレーン市場ではトップレベルです。 また弊社のクライアントは、強力な研究開発力 (R&D)、製造工場、およびカスタマーサービスセンターを世界中に展開しています。 日本のクレーン市場のニーズにより適合した製品とサービスを提供するために、競争力のある報酬と福利厚生を備えたプロダクト&サービスチームを現在構築しています。 業務内容 日本市場におけるクレーンのプロダクト・プランニング、競合他社調査、およびマーケティングの管理 日本のクレーン産業に関連する政策や規制に沿った業務 クレーンの研究開発概念(R&D)、技術、製造プロセス、職人技術の調査、およびセミナーの担当 輸出認証に関するプロジェクトマネジメント クレーン製品部品の現地調達計画と現地供給の導入の担当 クレーン設備の適応性改善 必須条件 8年以上のプロダクトマネジメント経験、または同等の経験 R&Dマネジメント経験 日本のクレーン市場に精通している方 ビジネスレベルの日本語力 社内外の関係者を円滑に動かすドキュメンテーション・コミュニケーションスキル 四大卒以上(工学部なら尚良)...
JOB SUMMARY Supports the day-to-day execution of general ledger impacted processes, including support to clients as they work with and understand these processes. Performs accounting functions specifically in the areas of account balancing, ledger reconciliation, reporting
At Accelleron, we go further. Building on the heritage of more than 100 years as ABB Turbocharging, you will join a team of true experts in an exciting international environment that share a commitment to excel,
At MFS, you will find a culture that supports you in doing what you do best. Our employees work together to reach better outcomes, favoring the strongest idea over the strongest individual. We put people first
Job Purpose: Responsible for driving commercial success in Japan LOC by leading GSK X-functional team Member of the Global/LOC cross-functional, shaping global strategy and co-creation Key Responsibilities: Understand global strategy and initiatives, as well as local
JOB SUMMARY Assists the Front Office Manager in administering front office functions and supervising staff on a daily basis. Front office areas include Bell/Door Staff, Switchboard and Guest Services/Front Desk. Position directs and works with managers