cta

Job Purpose This role leads all CTA submission activities for new assets and pipeline products, ensuring timely and compliant regulatory submissions through effective stakeholder management and strategic planning to accelerate access to innovative therapies. While the primary focus of this role is CTA submission leadership, the position also provides support...

Position Summary: Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an...

Position Summary: Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an...

일진다이아몬드는 빠르게 변화하는 경영 환경 속에서 지속적인 경영 혁신과 기술 개발을 통해 미국, 유럽, 일본, 중국 등 세계시장에 진출하였으며, Superabrasive Material Industry 에서 글로벌 Top3를 차지하는 선도 기업으로서 위상을 드높이고 있습니다.‘The Leading Company of Tool...

■ Position(직책): ​재무기획/관리회계(차~부장급)■ ​Location(소속사/근무지): ​ReNA 리에나/서울 ​서초구■ Responsiblities(담당업무):  지주사에서 자회사 ​관리회계 ​업무와 수익성 ​분석 등 재무성과를 ​통합 관리하고,  ​부문 ​및 회사별 ​특성을 ​반영한...

■ Position(직책): ​재무기획/관리회계(과장~차장급)■ ​Location(소속사/근무지): ​ReNA 리에나/서울 ​서초구■ Responsiblities(담당업무):  지주사에서 자회사 ​관리회계 ​업무와 수익성 ​분석 등 재무성과를 ​통합 관리하고,  ​부문 ​및 회사별 ​특성을 ​반영한...

Career CategoryRegulatoryJob DescriptionGroup PurposeLocal Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.  Job SummaryThe Local Regulatory Representative (Manager) is assigned to one or more Amgen products. The product(s) assigned have medium...

Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

Job Description SummaryThe RA specialist sets registration plan and perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy. Job DescriptionMajor accountabilities: Major accountabilitiesReview pipeline and set the registration strategy in collaboration...

📋 주요 ​업무합성의약품 ​CMC(API/DP) ​개발단계 품질보증 ​전략 수립, 문서검토 및 ​Compliance ​관리품질시스템 운영 ​(Deviation, OOS, CAPA, ​Change Control, ​Risk ​Assessment)CMO/CRO/공급업체 Qualification ​및 ​Vendor ​AuditIND/CTA/NDA 등 CMC ​규제자료 ​품질 검토, 규제기관...

Location: minimum ​2 ​days ​onsite in ​Waltham, MA office Cambridge / ​Greater ​BostonVoronoi is ​seeking a dynamic ​Medical Director ​who ​thrives in ​a ​fast-paced ​environment to partner ​cross ​functionally with drug ​discovery, ​translational ​medicine, clinical operations, ​clinical investigators ​and...

"우리와 함께 ​할 ​업무에요." ​CT(CTA) 기반 ​혈관 및 및 비혈관 ​영역의 ​Segmentation 모델 ​개발Centerline 추출 및 ​해부학적 구조 ​분석 ​알고리즘 개발Stent-graft ​시술을 ​위한 ​측정 자동화 및 ​시술 ​가이던스 알고리즘 연구Lesion ​Detection ​및 ​시술 후...

    Your new role Financial Reporting & Statutory Compliance: Manage the month-end and year-end closing process, prepare and oversee annual statutory financial statements in accordance with K-GAAP and IFRS, ensuring accuracy and on-time submission to relevant authorities; Report financial results to regional and global headquarters in accordance with...

함께할 팀을 ​소개합니다 ​🙌조코딩AX파트너스의 ​WHY는 분명합니다.대한민국 ​기업을 AI-Native하게 만드는 것.우리는 ​이미 ​강력한 무기를 ​가지고 있습니다. 수많은 ​사람들이 AI·코딩을 ​시작하게 ​만든 조코딩 ​브랜드와 ​콘텐츠, ​그리고...

"우리와 함께 ​할 ​업무에요." ​CT(CTA) 기반 ​의료영상 Viewer 핵심 모듈 ​설계 ​및 개발 ​ ​ ​ ​- 2D/3D ​영상 ​렌더링, ​MPR(Multi-Planar Reconstruction), 측정/주석 ​기능 ​등AI 모델 추론 ​결과(Segmentation, ​Centerline, ​Sizing 등)의 시각화 ​및 인터랙션...

Company DescriptionAbout the teamAt Canva, our mission is to empower the world to design.Korea is one of our fastest-growing markets, and we're building a brand here that locals love — through campaigns, partnerships, and a steady drumbeat of always-on content. As our marketing programme scales, we need someone who can help us produce creative work at...

Company DescriptionAbout the teamAt Canva, our mission is to empower the world to design.Korea is one of our fastest-growing markets, and we're building a brand here that locals love — through campaigns, partnerships, and a steady drumbeat of always-on content. As our marketing programme scales, we need someone who can help us produce creative work at...

**Company Description** It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could do that for everyone—freeing people from busywork so they could focus on meaningful work. Today, ServiceNow is the AI control tower for business...

About the job:Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities.Further, services will ensure the...