- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead ... product safety strategy or specific areas of safety surveillance and risk management, and provide... surveillance and risk management, and provide safety leadership including but not limited to clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical practice and ... efforts. Safety Expert - Signal Evaluation: Assists manager in assessing new signals. Safety Expert - Risk Mitigation & Communication: Communicates any … more
- Tris Pharma (Monmouth Junction, NJ)
- …periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...of ad hoc aggregate safety reports, periodic safety reports, signal detection activities and risk … more
- Insmed Incorporated (Bridgewater, NJ)
- …the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products ... disease experience preferred.Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving … more
- Merck & Co. (Rahway, NJ)
- … Director , as a senior member of the Global Regulatory Affairs and Clinical Safety : Chemistry, Manufacturing and Controls Organization (GRACS CMC), will also ... expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC professionals and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as ... possible. This led us to create the Translational Patient Safety Senior Director position, which will have...marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to… 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
- Merck & Co. (North Wales, PA)
- …and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product ... Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… 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 ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... to realize your potential? The Position To support the Director of US Tax Operations in leading and managing...in leading and managing tax operations, tax compliance, tax risk and indirect taxes for Novo Nordisk Inc. (NNI),… more
- Merck & Co. (North Wales, PA)
- …assets, ensuring adequate integration of data and scientific evidence with patient safety and clinical relevance elements in a customer-centric approach.-Review ... development and/or updates to support addressing MIRs.Actively contact and interact with Risk Management Safety Team(s) when required.Act as SME for… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality, audits and inspections, raw materials...all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize ... safety studies, and contribute to the development and review of safety documents including Risk Management PlansEfficiency of Process, SOP: Leads the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/ Clinical Departments. The incumbent will ... New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of… 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 ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics… more
- Merck & Co. (Rahway, NJ)
- …The Senior Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
