- Novo Nordisk Inc. (Plainsboro, NJ)
- …as budget review and forecasting Independently manage interactions with clinical monitors, data management, safety , regulatory and QA team members, both ... study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure... study progress and surveillance of key efficacy and safety data points Collaborate with other functions… 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
- Insmed Incorporated (San Diego, CA)
- …of clinical studies, review & interpretation of clinical trial data , authoring clinical study and regulatory communications and documents, and ... study reports and data interpretation/communication.Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s),...communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify… more
- Novo Nordisk Inc. (WA)
- …the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory ... Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials Verifies safety reporting and the...regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in… more
- Genmab (Plainsboro, NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… 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 ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational... Data Sheets (CCDS) for assigned products. This position drives/leads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …using suitable Pharmacovigilance database retrieval strategies Experience with safety data collection and interpretation originating from clinical trials and ... About the Department The Clinical , Medical and Regulatory (CMR) department...management on matters concerning safety promotional review, safety labelling committee input, safety data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, ... tactical priorities and require complex analysis of situations and data Establishes new or improved methods within field of... committees Participate as a member of the first safety committee chaired by non- clinical , where … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI ... with global PV regulations and the contractual obligations that govern the exchange of safety data between partners in relation to marketed and clinical … 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) ... and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the… more
- Merck & Co. (Rahway, NJ)
- …including complex data preprocessing, filtering, and manipulation;Programming expertise with clinical endpoint data (efficacy and safety ) and ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing... sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… more
- Merck & Co. (North Wales, PA)
- …operational objectives and fosters productive collaborations with stakeholders in Biostatistics, Clinical Research, Data Management, Regulatory Affairs, and ... areas and stakeholders including Translational Medicine, Early Oncology, Biomarkers, PK/PD, Clinical Safety , Chemistry, Manufacturing, and Controls and Secondary… more
- Genmab (Plainsboro, NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages for… more
- Merck & Co. (North Wales, PA)
- …the benefit of patients and global human health. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical ... clinical studies using deep scientific knowledge, statistical-analysis and high-quality data to support decision making in clinical trials.-The Associate… 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) ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Genmab (Plainsboro, NJ)
- …and in a compliant manner with colleagues in other functional areasEnsures optimal safety , clinical oversight and highest quality standards are applied to all ... and technological advancements.Strong analytical and problem-solving skills, with a data -driven approach to decision-making. Regulatory experience is a… more
