- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works… 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 ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… 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
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Clinical Study Start-Up activities for PV Safety ...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… 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
- 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)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange ... process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidenceReview of Change… 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)
- …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
- 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
- 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)
- …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
- System One (Basking Ridge, NJ)
- Director Clinical Safety 12 month contract Hourly Pay Max: $100- $120 (dependent on experience) Fully remote Description: The Director , Clinical ... specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity ... development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with...Regulatory Authorities) + Performs and mentors direct reports in clinical /medical data review, including safety monitoring and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- ** Director , Clinical Development** **Join a Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of ... primary source of medical accountability and oversight for one or more clinical trials *Matrix management responsibilities across the internal and external network… more
- RWJBarnabas Health (New Brunswick, NJ)
- Assistant Clinical Director , Coronary Care UnitReq #:0000160141 Category:Nursing Manager Status:Full-Time Shift:Night Facility:RWJ New Brunswick ... Wood Johnson Place, New Brunswick, NJ 08901 Job Overview: RWJBH is seeking an Assistant Clinical Director for our Coronary Care Unit at the New Brunswick campus.… more
- RWJBarnabas Health (New Brunswick, NJ)
- Assistant Clinical Director , Pediatrics IIReq #:0000156381 Category:Nursing Manager Status:Part-Time Shift:Night Facility:RWJ New Brunswick Department:Pediatrics ... Johnson Place, New Brunswick, NJ 08901 Job Overview: RWJBH is seeking an Assistant Clinical Director for our Pediatrics II Department at the Bristol Myers Squibb… more
- Edwards Lifesciences (Trenton, NJ)
- …how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness, safety and value of our ... lives. Join us and be part of our inspiring journey. As the ** Director , Clinical Affairs ( Clinical Data & Evidence Strategy),** you will be responsible… more
- Bristol Myers Squibb (Princeton, NJ)
- …with the Clinical Scientist for medical questions and education (including safety management guidelines) + Assesses key safety -related serious adverse events ... strategic oversight in protocol development (input on inclusion/exclusion and other safety -related clinical considerations) + Fulfills GCP and compliance… more
