- 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)
- ** 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + May contribute to preparations for external /stakeholder meetings ... early and/or late phase development. Reports to the Senior Director , Clinical Sciences and collaborates closely with...(IM, Governance, DMCs, Regulatory Authority) + Supports clinical /medical data review, including safety monitoring and… more
- St. Luke's University Health Network (Bethlehem, PA)
- …Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety ... and actions. SUPERVISION (RECEIVED BY AND/OR GIVEN TO): Received: Pharmacy Management - Clinical coordinator, site director of pharmacy, network director of… more
- Atlantic Health System (Basking Ridge, NJ)
- …/ staff meetings. + Visit private duty nursing cases at the request of the clinical director + Train agency staff on software computer programs and materials. + ... care teams to maintain the standards of professional nursing practices in a clinical setting 2. Collect comprehensive data on patients' health (from patients and/or… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- St. Luke's University Health Network (Stroudsburg, PA)
- … clinical care/outcomes, customer service improvement, operational data, and safety . Mentorship Take responsibility for professional development with the use of ... of equipment and supplies needed to maintain quality and safety of student-athlete care. Athletic Trainers shall assist the...BY AND/OR GIVEN TO): The assigned Sports Medicine Medical Director is responsible for ultimate decision with clinical… more
- Zufall Health Center (Bridgewater, NJ)
- …Position Summary: A full time, non-exempt position reports to the site manager with clinical oversight from Director of Dental Services, Director of Nursing, ... Dental Department patients, monitors patient flow, and assists the Director of Dental Services, dentist(s) and dental hygienist(s) is...but not limited to participating in the provision of clinical dental care, as well as workplace safety… more
- St. Luke's University Health Network (Bethlehem, PA)
- …Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety ... of equipment and supplies needed to maintain quality and safety of student-athlete care. Assists with the overall sscheduling...GIVEN TO): Responsible to the Sports Medicine Physicians for clinical issues. Also, supervised by the Director ,… more