- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), Global Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analyses. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Merck & Co. (Rahway, NJ)
- …regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, ... but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize… 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… 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)
- … 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
- Mercy University (Dobbs Ferry, NY)
- Nursing Associate Director of Clinical Simulation Lab Print (https://www.schooljobs.com/careers/mercyedu/jobs/newprint/4377897) Apply Nursing Associate ... Non-Union + Description + Benefits Job Posting Summary The Associate Director of the Clinical ...medical skills learning lab. Recent medical surgical experience. + Safety standards and practices used in lab/classroom settings. Education… 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)
- …and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team ... objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts… 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
- 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)
- …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
- Bristol Myers Squibb (New York, NY)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing ... support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to...timelines + Contributes to managing external communication when significant safety issues arise, with the well-being of patients being… more
