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: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to ensure the
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
JOB SUMMARY Accountable for overall success of the daily kitchen operations. Exhibits culinary talents by personally performing tasks while leading the staff and managing all food related functions. Works to continually improve guest and employee satisfaction
HOTEL DESCRIPTION Kagoshima is the southwestern prefecture of the Kyushu Island. Major economic pillars of the prefecture include agricultural and food, electronic and automotive-related industries. The Hotel will be part of a mixed-use development that comprises
RWE Renewables Japan G.K. To start as soon as possible, full time, permanent Location: Tokyo,Japan Functional area: Human Resources Your Role: Our Human Resources department (People Management APAC) within RWE Renewables is looking for a Human Resources Operations Manager Japan. At RWE Renewables
JOB SUMMARY As the original house of luxury, St. Regis continues to redefine modern luxury through service. At the core is the Butler program, an icon to our heritage and the heart and soul of new
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
JOB SUMMARY Exhibits creative baking and decorating talents by personally performing tasks while leading the staff in preparing quality and consistent pastries for all areas. Works to continually improve guest and employee satisfaction while maintaining the
JOB SUMMARY Accountable for overall success of the daily kitchen operations. Exhibits culinary talents by personally performing tasks while leading the staff and managing all food related functions. Works to continually improve guest and employee satisfaction
企業概要 Sika is a specialty chemicals company with a leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protecting in the building sector and motor vehicle industry. Sika
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
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,
JOB SUMMARY Assists the Director of Human Resources in executing strategies that serve to attract, retain, and develop diverse premiere talent. Position directs and works with human resource employees to carry out the daily activities of the Human Resource Department, including recruitment, total
Line of Service Internal Firm Services Industry/Sector Not Applicable Specialism IFS - Human Capital (HC) Management Level Senior Associate Job Description & Summary Our Human Capital department (HC), within the Internal Firm Services, assists the Firm in making a
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
JOB SUMMARY Helps drive company values and philosophy and ensures all training and development activities are strategically linked to the organization’s mission and vision. Works with property leadership team to identify and address employee and organizational
JOB SUMMARY Must have Japanese citizenship or Eligible work in Japan permit holder Assists the Front Office Manager in administering front office functions and supervising staff on a daily basis. Front office areas include Bell/Door Staff,
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
JOB SUMMARY Must have Japanese citizenship or Eligible work in Japan permit holder Position has responsibility for supervising and coordinating activities of employees delivering spa services, including salon, skin care, program coordination, reservations, reception desk, massage
