- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Clinical Safety global business processes. This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees ... This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … safety issues supporting Global Medical Safety Lead. Responsible for safety governance/oversight of Clinical Safety and risk management activities. ... Medical Safety collaborations within and across line functions, eg Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations. Formulates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high ... documentation. Collaborates cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety and Pharmacovigilance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug coding conventions (MedDRA, WHO-DD)- Knowledge of FDA and global PV regulations, clinical and safety databases- Familiarity with Good Clinical ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business… more
- Merck & Co. (Rahway, NJ)
- …of statistical datasets that support multiple stakeholder groups, including clinical development and safety evaluation.Collaborate with statistics and ... Job DescriptionResponsibilities:Utilize big data to analyze the safety and efficacy claims of potential medical breakthroughs.Support statistical programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Merck & Co. (North Wales, PA)
- …assets, ensuring adequate integration of data and scientific evidence with patient safety and clinical relevance elements in a customer-centric approachReview ... to further differentiate our portfolio.The Medical Consult and Review Physician provides clinical expertise and advice to internal stakeholders and is a member of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the strategy, development, effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety , therapeutic area leads, MSLs ... developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs, Patient Safety required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position ... drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. ... medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Director has primary… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for...has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With… more
- Genmab (NJ)
- …implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various ... stages of clinical development (including clinical trial implementation, and...regulatory documents and registration dossiers (ie, protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's… more
- Merck & Co. (Rahway, NJ)
- …Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic area,… more
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