- Merck & Co. (Rahway, NJ)
- …a particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including ... monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical and translational… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... medicine.JOB DESCRIPTION:Summary, Focus and Purpose -The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- …technologies for batch and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads ... standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Director Manufacturing Operations (m/f/d) -shapes the… more
- Merck & Co. (Rahway, NJ)
- …processes communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...management, performance monitoring, continuous improvement activities that ensure the safety , effectiveness, and compliance of the company's products.- The… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... trials and will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible for:-Evaluating pre- clinical and… 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)
- …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 ... 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)
- …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)
- …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
- 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
- Win (Women In Need) (New York, NY)
- …of care for high-risk clients in collaboration with Program Director to make clinical decisions regarding client care and safety . * Monitor and engage all ... Title of Position: Clinical Director (LCSW or LMHC) FLSA Status: Exempt Department: Transitional Housing Reports to: Program Director Positions reporting to… more
- Merck (Rahway, NJ)
- …with a particular focus on obesity and obesity-related metabolic disorders. The Senior Director will manage the entire cycle of clinical development, including ... placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be responsible for** + Evaluating pre- clinical … more
