We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. We work directly with individuals to help them gain the skills, confidence and connections to transform their
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 GSK?
JOB SUMMARY Entry level management position that focuses on supporting the day-to-day activities in Housekeeping, Recreation/Health Club and Laundry, if applicable. Position works with employees to clean and maintain guestrooms and public space. Completes inspections and holds
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 training
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
Building a team starts with valuing the team. We hire the best of the best to ensure you’re working with people you can constantly learn from. You’re trusted to get your work done your way while
This role is as a key member on the team of International Coverage Executives (ICEs) based in Tokyo covering subsidiaries of commercial banking clients. As a CBI Banker within Commercial Bank International, you’ll manage J.P. Morgans
Application Deadline: 08/22/2024 Address: 12545 Central Ave. Job Family Group: Retail Banking Sales & Service The mission of Premier Services is to help mass affluent clientele make real financial progress by understanding and planning for what
International Technology Product Manager (Japan) Our solutions make a difference – and so do our people. Wolters Kluwer Healths Clinical Effectiveness (CE) organization is a fast-growing and innovation-driven healthcare information technology (HIT) provider working on the front
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle
* To contribute in designing and implementing a functional B2B web page application * Work together in a team of UIUX Designers to make functional designs and user experience decisions Client Details The company is one
Job Description We are seeking a talented, motivated and self-driven professional to join Human Health Digital, Data, Analytics (HHDDA) organization and play an active role in our company’s journey to become the premier “Data First” commercial biopharma
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
Type of Requisition: Regular Clearance Level Must Currently Possess: Top Secret/SCI Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Suitability: Public Trust/Other Required: None Job Family: Information Security Job Qualifications: Skills: Information
■ 職務内容 / Job Description Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in
Position Overview At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to
About the Role: Grade Level (for internal use): 10 Senior Analyst (Corporate Governance & M&A) Background: S&P Global Governance Solutions and M&A team is seeking a highly skilled corporate governance expert for a consultative, advisory, and
