- 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59023 ... new people to make a difference with. **The opportunity** Director , Clinical Development is responsible for the...relevant countries and Teva Standard Operating Procedures + Resolves safety or relevant clinical issues in consultation… 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
- Prime Healthcare (Denville, NJ)
- …#LI-CC2 Connect With Us! (https://careers-primehealthcare.icims.com/jobs/174925/ director clinical -lab/job?mode=apply&apply=yes&in\_iframe=1&hashed=-336024306) ... received multiple quality awards including Leapfrog "A" ratings for patient safety ; Healthgrades recognition for orthopedic surgery, treatment of stroke, heart care,… 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
- Atlantic Health System (Morristown, NJ)
- Atlantic Health System/Goryeb Children's Hospital is Seeking a Program Director for our Pediatric Residency Training Program located in Morristown, New Jersey The ... Kimmel Medical College at Thomas Jefferson University. The role of Program Director involves a commitment of 60% administrative responsibilities and 40% clinical… more
- Atlantic Health System (Morristown, NJ)
- …largest non-profit healthcare networks in New Jersey, is seeking a System Medical Director of Women's Services to oversee the strategic growth of the service line ... counties in Northern and Central New Jersey. The Medical Director of Women's Services will provide leadership and direction...leadership and direction on new program development by connecting clinical leaders from across the system, as well as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regulations and IND Safety Reporting. + Industry experience of clinical safety , pharmacovigilance operations, and medical review. Oncology experience ... (GVP), including worldwide PV regulations and their application to individual case safety reports. + Excellent scientific/ clinical and analytical knowledge base,… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Performs clinical /medical data review, including safety ... through early and/or late phase development. The Sr. Manager reports to the Director , Clinical Sciences and collaborates closely with Medical Director (s)… more
- Prime Healthcare (Dover, NJ)
- …received multiple quality awards including Leapfrog "A" ratings for patient safety ; Healthgrades recognition for orthopedic surgery, treatment of stroke, heart care, ... performance and either correct the problem or immediately notify your immediate supervisor, Director , or Medical Director , 4) perform a wide variety of… more