- Daiichi Sankyo, Inc. (Bernards, 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 ... Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and ... Head of CSPV.Overall, this position has both leadership and management responsibilities and is considered a global ...successfully a team of physicians and scientists, accountable for safety surveillance and risk management activities for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to maintain compliance with global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements ... centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... 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. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... for cardiovascular diseases, 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)
- …and Development within pharmaceuticals life science industry as well as experience with Global Safety Case Intake, Processing, Management and Reporting. ... Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervises a team of CMR Learning Support Partners, technical trainers and knowledge management staff. Closely partners with line leaders, Global Development key ... most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …efforts under the company's human rights policy, and support data collection for global health management and access to healthcare programs. Develop ... sustainability websites and value report, arranging and supporting Environmental Health and Safety (EHS) audit requests. Qualifications: Successful candidates… more
- Merck & Co. (North Wales, PA)
- …marketing of medical drugs and vaccines for the benefit of patients and global human health . This position supports statistical programming activities for late ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human health .This position supports statistical programming activities for multiple ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Merck & Co. (Rahway, NJ)
- …communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality ... that the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to support manufacturing… more
- Insmed Incorporated (San Diego, CA)
- …company at regulatory meetings including presentation at Advisory Committee Meetings.Preparing safety charters, DMC charters, or other specific management plans ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...to gather inputOrganize scientific advisory board meetings and data safety monitoring committee meetingsMaintain a high level of clinical… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... scientific support to clinical development and operations, regulatory, medical affairs, drug safety , and quality assurance teams, as well as overall program support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...implementation for mechanical systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing.… more
- Merck & Co. (Rahway, NJ)
- …laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business ... release and stability testing for biologic therapies in clinical development, impacting global patient health and wellness.Responsibilities include, but are not… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset,… more
- Merck & Co. (Rahway, NJ)
- …high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Director Manufacturing Operations (m/f/d) ... management to meet all operational requirements sustaining both global and local competitiveness and diversity.Establishes robust succession plans and drives… more
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