- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... pipeline.This person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… 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. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety MD Pharma In New Jersey - Remote (no west coast, only EST or CST) 12 month contract | Up to $100/hr dependent on ... a plus + international MD is okay + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in pharmaceutical drugs either from relevant work experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr ( Associate Director ), 4-8yr ( Director ) prior industry experience or ... The Associate Medical Director works with their...ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation… more
- Merck (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... person will:** + Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function which ... provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Responsible for implementation,… more
- The Mount Sinai Health System (New York, NY)
- … safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... **JOB DESCRIPTION** The Clinical Research Associate is an integral...as assigned. ** Safety Reporting:** + Assists the Associate Director of Research and Quality Outcomes… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Safety Scientist in... (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + With oversight from the GM&ES CDU TFA Primary Responsible, ... an assigned therapeutic candidate: Responsible for the analysis of clinical data, including safety monitoring, responsible for...academic clinical trials (10 years post fellowship clinical and research experience, associate or full… more
- Pfizer (Pearl River, NY)
- …into country feasibility. **Support study team** + With supervision of medical monitor ( director /Sr director ) provides clinical input to protocol/study team ... Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… more
- Pfizer (Pearl River, NY)
- …of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety . + The clinician medical ... + Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… more
- Pfizer (Pearl River, NY)
- …of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety . In addition to study ... Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… more
- Graham Windham (Bronx, NY)
- …day-to-day operations of the Enhanced Family Foster Care Services. With the Clinical Director 's strong administrative and operational oversight, we will ... Clinical Foster Care Director Job Details...family as quickly as possible. Position Responsibilities: Ensures the safety and stability of all children receiving EFFC services… more
