Are you interested in a regulatory affairs role that allows you to mitigate risk and accelerate compliance across the business? If so, this Regulatory Compliance Manager could be an ideal opportunity to explore. As a Regulatory
About Chain IQ Chain IQ is an Independent Global Indirect Procurement company providing strategic, tactical, and operational procurement services. Headquartered in Zurich, Switzerland Chain IQ operates from 6 main centers and 14 offices worldwide. Our team
The Japan MN Delivery NPO Lead will be accountable to develop the Japan NPO Business Strategy and drive all future NPO Business growth across CSPs in Japan. The expectation is the successful candidate will work closely
Objectives of the Position Responsible for financial planning, forecasting, reporting, business analysis and commercial controlling support for Agricultural Solutions business in Japan. Act as financial advisor, challenger and business partner to the Agricultural Solutions Japan Business
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
JOB SUMMARY The Area Director of Sales & Distribution, is the sales leader for several properties within designated area. The position provides leadership, direction, management to the on-property and the multi-property sales teams (if applicable) to
Were the global leader in providing energy solutions that help businesses grow and communities thrive. We work as a team and we’re proud of the difference we make to customers, to local communities, and towards a
About Applied Intuition Applied Intuition is a Tier 1 vehicle software supplier that accelerates the adoption of safe and intelligent machines worldwide. Founded in 2017, Applied Intuition delivers the definitive ADAS/AD toolchain and a world-class vehicle
The Red Hat Services Team is looking for a Senior Manager for the Technical Account Management Team in Japan to be aligned with our Japan Services Region. In this role, you will oversee a team of
Job Title: Private Equity Investment Analyst Location: Remote (EST Time Zones) Salary Range: up to 3,500 USD (Negotiable) Work Schedule: Monday to Friday, offering flexible hours between 8 am and 10 pm EST NOTE: INDEPENDENT CONTRACTOR
[Freelance Remote Position] English to Japanese Terminologist Are you a hidden inquisitive homo ludens with an organized mind? Yes? Join us as a terminologist! You will play a key role in the proper name localization for
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Plan (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 およびその計画の実行に責任を持ちます。Evidence NeedsおよびGapを評価し、製品価値を高めるための最も 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 までの広い責任と職務をリードしていきます。 また、ワクチン領域においては、定期接種や自治体の予防接種補助金の根拠となるCost Effectivenessモデルの構築やその推定結果をEvidenceとして公表すること、ならびに臨床開発早期の段階にある製品Pipelineに 対して、日本やアジアの疫学的な視点から助言し、承認取得までの臨床開発計画におけるEvidence Gapを 評価し、製品Launchの前後に必要な最適なVEP/IEPを企画・立案・提案することが求められます。 The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP)
The Supply & Demand Planning Manager is responsible for the Supply & Demand Planning process at Operating Company/BU level. This position will be in Japan and Native or equivalent level of Japanese language and Business English
このポジションはネイティブもしくはそれ同等レベルの日本語力とビジネス英語力が必須となります。This position requires Native or Equivalent level of Japanese language and Business English. To coordinate purchasing activities with manufacturing and sales departments to acquire raw materials, components, equipment and services in a cost effective and timely
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
About the role The Head of ER is a senior management position that oversees the employee relations function of the organization. The Head of ER is responsible for developing and implementing policies and practices that foster
Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve
At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric
At Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. OpenEye, Cadence Molecular Sciences – a division of Cadence Design Systems – is an industry leader in
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 安全対策の検討と実行を主軸として、製品ライフサイクルを通して被験者・患者さんの安全性の確保に貢献する。 承認に向けてGSK Japanが遂行する開発プロジェクトを成功させるべく、クロスファンクショナルに活動する。治験において、治験参加者の安全を確保する試験計画を立て、得られた安全性データを適切に監視し、Global Safetyの方針に沿ったリスク対策を講じる。治験等で得られたデータに基づき、日本の医療環境を考慮したリスク管理を立案し、承認取得に貢献する。 承認取得後は、GSK Japanが承認取得した医薬品（Pharma製品、Vaccine製剤）及び医療機器を、医療従事者及び患者さんが常に安全・安心・適正に使用できるように、実臨床下で使用された際に得られる安全性情報及び関連する情報に基づき安全対策をGlobal Safety/Medicalチームと議論し立案・実行・効果検証を行う。また、臨床研究等Evidence generationにおいても参加者の安全確保に貢献する。 Human Subject Researchにおいて、患者の安全を考慮し、必要な安全性情報が得られるように臨床試験を計画し、得られた情報を安全対策に活用する。 治験薬概要書の作成 治験（試験）実施計画書、患者同意説明文書のレビュー Dear Investigator Letterなど重大なリスクへの対応 Global Safetyや国内関連部署と連携して申請資料を作成し、承認を取得するために照会事項に対してPMDAと協議する。 Global Safetyや関連部署との申請スケジュールの確認、協力要請 医薬品リスク管理計画（RMP）の作成（日本におけるリスク特定、資材の立案を含む）及び照会対応 電子添文の使用上の注意の作成及び照会対応 GCP適合性調査 GSK製品の安全対策の立案及び実施（リスクマネジメント）：上記評価・分析結果及び医療環境等の外部環境を勘案した、医療従事者及び／又は患者さん向けの安全対策を立案・実施し、その効果を検証する。 医薬品リスク管理計画（RMP：Risk Management Plan）の作成及び維持管理 市販直後調査［EPPV］の企画及び報告書の作成 医療従事者向け情報提供資材の作成、患者向け情報提供資材の作成 電子添文（使用上の注意）の改訂とお知らせ文書の作成
