JOB DESCRIPTION Job Title: Associate Director, Regulatory Affairs Japan Department / Cost Center: Regulatory – 210 Reports to (Job Title): Head of APAC Regulatory Affairs Job Code: Location: Tokyo Date Prepared: April 2024 Full-Time Part-Time Regular
Job Description A series of operations serving pharmaceuticals and medical device manufacturers as clients, from research planning to output creation to meet client issues Responsibilities Act as the clients window for research operations in general, such as
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
【AF】EP product manager Position Overview: We are seeking a highly motivated and experienced Product Manager to join our dynamic team. The Product Manager will play a crucial role in the successful launch and growth of a
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
職務 概要 Position Summary : 富士 New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering )は以下職務を行う。 The New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering ) for as follow l 富士工場新製品導入のガバナンス,プロジェクトの実施 Execute governance and project for Fuji
Description Key responsibilities 1. Directly manage a medium sized team responsible for effective execution of Dr. Ci:Labo programs in alignment with category strategies driven efficiently through the most efficient technologies using aligned work processes. 2. Stakeholder
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)
Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of
Are you a detail-oriented finance professional with experience in financial and accounting operations? Are you an experienced Finance Manager looking for a new challenge? Novo Nordisk is seeking a talented Finance Manager to join our Finance
■ 職務内容 / Job Description Lead Safety Information Management Group to manage pharmacovigilance activities incl. collecting, evaluating, and submitting safety information to relevant parties (e.g. PMDA, AZ global Patient Safety, licensing partners) and lead communication (incl.
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
Requisition ID 51727 Position Type FT Permanent Recruiter #LI-SS1 Posting Type LI About Kerry Kerry is the worlds leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
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
This is what you will do: Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and
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
Job Purpose： Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key Responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with brand lead to develop and
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
