- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Genmab (Plainsboro, NJ)
- …RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, ... safety committees Participate as a member of the first safety committee chaired by non- clinical , where Safety Surveillance will resume chairmanship going… more
