１．主な職務における成果責任/ Description of Primary Role & Responsibility (1) 組織横断的な開発戦略の立案を実行する ①プロジェクト・マネージャーは、プロジェクトの日本への導入から、市販後のライフサイクルマネジメントまでの全てのステージに渡って、製品価値の最大化に貢献し...
1. Job Objective: Japan Regulatory Leads (JRLs) formulate and conduct high quality development regulatory strategies in order to obtain simultaneous worldwide a...
[R&D] オンコロジー領域の開発薬事担当者（スタッフ） Position: Japan Regulatory Lead (JRL) for oncology products 1. Job Objective: JRLs formulate and conduct high quality development...
１．主な職務における成果責任/ Description of Primary Role & Responsibility ワクチンプロジェクトにおける臨床試験および承認申請資料作成のための解析プログラミング業務を行います。（詳細は、職務記述書を参照ください。） ワクチンプロジェクトに特化し，臨床試験の試験総括報告書を含...
内容の詳細はJOB-Dサイトをご確認ください。 ２．応募資格/ Qualifications 【資格・能力要件/ Desired Behavioral and Technical Skills】 戦略的かつ革新的な思考と問題解決力 社内外関係者とのコミュニケ－ション能力とネゴシエーション能力...
JOB SUMMARY Through a solid understanding of clinical study design and drug supply processes and risks, the Supply Chain Lead (SCL) develops supply strategies t...
１．主な職務における成果責任/ Description of Primary Role & Responsibility 【職務内容】 開発から申請/承認、承認後の製品のライフサイクルを通し、バイオ医薬品（ワクチン、遺伝子組換え抗体及び遺伝子治療製品等）の治験開始、承認申請及び承認後の変更管理において、製造方法、規格・...
Job Description Keysight is the worlds leading electronic measurement company, helping scientists, researchers, engineers and manufacturing experts address the...
Job Description Keysight is the worlds leading electronic measurement company, helping scientists, researchers, engineers and manufacturing experts address the...
Job Description Keysight is the worlds leading electronic measurement company, helping scientists, researchers, engineers and manufacturing experts address the...
Job Description Keysight is the worlds leading electronic measurement company, helping scientists, researchers, engineers and manufacturing experts address the...
Job Description Designs Keysight products and specifies the components that make up the products. Designs and develops products, components, processes, and syst...
Job Description This job is in CSG HFM COE team, where we research, design, and develop the world’s bestselling Network Analyzers and Device Test solution produ...
■市販後製品（化成品及びバイオ）のCMC薬事業務 ・変更管理に対する薬事アセスメント ・当局相談 ・申請戦略の立案 ・一変申請資料（承認申請書、添付資料）の作成及び照会対応 ・軽微届の作成 ・承認前GMP調査関連業務 ・上記業務におけるグローバルを含む関連部門との協議及び合意形成 ■一変申請業務を委託するCROのマネジ...
JOBSUMMARY: Responsible for providing statistical expertise in PMS programs, study design, data analysis and interpretation of results for PMS studies. Provide ...
Position Summary: Responsible for providing statistical expertise in clinical development programs, compound level development strategy, study design, data anal...
We have a new and exciting opportunity to hire a Dr. Ci:Labo (DCL) local Safety Specialist for our Pharmacovigilance here at Tokyo, Japan DCL office. The positi...
Position Summary: Responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials and/or overseeing a Clinical Research...
The Portfolio Lead, Statistical Programming is an experienced functional area project leader with expert knowledge of Statistical Programming strategy, concepts...
POSITION SUMMARY From investigational phase through post-marketed phase, in support of JRML (Japan Risk Management Lead), take necessary responsibility to provi...
