- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... the latest technologies and tools available Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...to lift 0-10 lbs. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and clinical trials complaint handling Ensures local/affiliate SDEA templates meet both Global and local regulatory requirements Supports audit and inspection ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...review and vendor management support in regards to safety reporting . To serves as a liaison between NNI Patient… more
- Merck & Co. (Rahway, NJ)
- …engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and ... commercial input on such activities as:target product profile (TPP) development, global regulatory filing strategy, launch readiness reviews, organized customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:- Global Phase I subject and patient trials, safety reporting , and regulatory WMA submission experience a plus. NOTICE FOR INTERNAL ... processes.- Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.--Represents Early Stage Development on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10%Daiichi Sankyo, Inc. is an ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model,maintaining and managing a project ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Eisai, Inc (Nutley, NJ)
- …roadmap aligns with infrastructure, security and/or corporate systems' roadmaps. Collaborate with global finance for the planning, approval and reporting of ... experience with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting ) and the systems that support ... training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way… more
- Aequor (San Diego, CA)
- …execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveAppropriately perform ... deliverables including single case and aggregate safety monitoring, safety reporting , contribution to benefit-risk assessment, risk management planning and strategy,… more
- Merck & Co. (Rahway, NJ)
- …our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and ... appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (Bridgewater, NJ)
- …Management Plans. Directs the compilation and interpretation of safety data for reporting purposes, including marketing applications to regulatory agencies, in ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform.../or contractors to ensure compliance with company policies and regulatory requirements on safety data reporting , collection,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
