- 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)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for ... disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… 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)
- …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)
- …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
- Actalent (Basking Ridge, NJ)
- Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for leading overall product safety ... safety , including project-specific training and coaching. + Represent the Clinical Safety and Pharmacovigilance (CSPV) on the Global Product Team… 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
- Daiichi Sankyo Inc. (Basking Ridge, 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… 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
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …origin, protected veteran status, disability or any other legally protected status. Director Clinical Development - Base Salary range $200,000 - $250,000 ... as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites...Sr. Director Clinical Development - Base Salary range… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the ... disorders. **Job Summary:** The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … 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
- J&J Family of Companies (Raritan, NJ)
- … Study Reports (CSR) + Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings + Periodic Benefit Risk Evaluation Report ... Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid...GMS representative on the Compound Development Team (CDT) and Clinical Teams + Anticipate safety concerns and… more
- AbbVie (Branchburg, NJ)
- …Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation ... surveillance and authorship of PV documents *Analyze and interpret pre- clinical and clinical safety data and communicate the analysis and interpretation… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. **Responsibilities** ... process improvements. + Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence + Review of… more
