Job Description: Position: Manager, Legal & Compliance Department/Section: Legal & Compliance Reference & position: Director, Head of Legal & ComplianceManager for: NA Purpose of the job: The purpose of this position is to support the organization
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials
Job Description 1. Objectives Responsible for clinical development of the assigned project in Japan under the supervision of the Japan Development Leader (JDL), who assumes responsibility for development of all projects in Japan in the respective
General Information Job Advert Title: Clinical Site Manager Ⅲ（臨床開発モニター/ Site Monitor/ CRA） Location: Nihonbashi, Tokyo Division: Clinical Operations, Quantitative Sciences and China Development Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors
The Associate Director, Data Scientist is responsible for applying advanced analytics, machine learning, epidemiology, and real-world data methods to support AstraZeneca Japan’s commercial PDCA cycle and evidence-based decision-making. The role builds and maintains models for territory
Position SummaryThe associate director, Market Access & Healthcare Policy (MAHP) in Japan is responsible for monitoring healthcare system and regulatory environment affecting Alexions business and advancing Alexions business priority in the policy area through building, maintaining, and
This is what you will do: Evidence Generation Lead manages all evidence generation program such as the Externally Sponsored Research (ESR), Medical Affairs conducting Phase 4 (P4) study Real-world evidence generation, HEOR study and Post marketing
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
This is what you will do: Evidence Generation Lead manages all evidence generation program such as the Externally Sponsored Research (ESR), Medical Affairs conducting Phase 4 (P4) study Real-world evidence generation, HEOR study and Post marketing
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Job TitleRegulatory Affairs Manager Job Description Job Title Regulatory Affairs Manager ポジション概要 フィリップスの医療機器事業において、Hospital Patient Monitoring（HPM） および Sleep & Respiratory Care（SRC） 領域の新製品導入および既存製品の許認可維持を担うポジションです。 また、AIを活用したプロセス改善・業務変革の推進にも携わり、日本国内のみならずグローバルチームと連携しながら、Patient Safety & Quality（PSQ）全体に影響を与える変革活動をリードしていただきます。 薬事の専門性に加え、組織横断での協働やリーダーシップを発揮し、事業成長とコンプライアンスの両立に貢献いただくことを期待しています。 主な業務内容 薬事戦略・申請業務 製品ライフサイクル全体を通じたコンプライアンス確保に向け、国内薬事戦略を策定し、関連ステークホルダーとの戦略的な議論をリードする 薬事戦略、開発計画および製品に関する規制リスクを主体的に特定し、適切な代替案を提案する 国内規制要件を解釈し、海外設計元へ適切な薬事アドバイスを提供する 薬事申請資料の作成・レビューを行い、承認申請業務を推進する 既存製品の承認維持管理を行う 薬事管理・規制対応 QMS/FMR登録業務、薬事評価、販促資材レビューなどの薬事管理業務を統括する 厚生労働省、医薬品医療機器総合機構、認証機関との折衝および良好な関係構築を行う PMS（市販後監視）チームおよび品質保証チームと連携し、規制課題への対応や継続的なコンプライアンス活動を推進する プロセス改善・業務変革 AIおよびデジタル技術を活用した業務効率化・プロセス改善を推進する
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It
Job Description SummaryThe Brand Manager is accountable for translating International and Regional Therapeutic Area strategy into locally relevant brand plans from pre-launch phase and ensuring future assets are positioned for long-term patient impact and sustainable business growth
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples