- 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
- 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
- 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
- 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)
- …relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful candidates will be able to meet ... 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
- 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)
- …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
- 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Senior Director, Toxicology is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence ... patterns and disease progression, answer clinical development questions, and support regulatory submissions.- In this role, the principal statistical programmer will… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for… 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
- Merck & Co. (Rahway, NJ)
- …company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance ... team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our… 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
- Merck & Co. (North Wales, PA)
- …(SDTM), provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting… more
- Merck & Co. (North Wales, PA)
- …Division QMS team for QMS updates as needed.Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support ... Job Description Description: Reporting to the AVP of New Modalities our...compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. This leader will… more
