- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree Science required Experience Qualifications4 or More Years drug safety experience with technical experience in Electronic Data Capture and ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews...experience in one or more of the following areas: Drug Safety , Epidemiology, and Clinical Development preferredDaiichi… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed ... of multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based...by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions,...Position This position will support company compliance to the Drug Supply Chain Security Act (DSCSA). This includes Line… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous… more
- HITT Contracting (New York, NY)
- …of the project on site consistent with the project schedule and HITT safety and quality standards. The Superintendent provides leadership and serves as the liaison ... for the construction project. ResponsibilitiesUnderstanding and administering the HITT safety program to include all subcontractors, ensuring that all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …procedures.Review and approve Validation/Qualification/Method Transfer protocols, completed Assay Data and Reports.Review and approve Completed Daily Assay ... driving compliance.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …models and support development of replication and attribution tools.Partner with the Risk Data Science & Analytics teams to innovate and develop solutions to enhance ... to make enhancements to risk tools.Develop and support frameworks and processes for data quality assurance.Work closely with vendors that provide critical data … more
- HITT Contracting (Newark, NJ)
- …aspects of each project in order to meet budget, quality, time and safety objectives. ResponsibilitiesWork with project manager in formulating project schedule, ... acceptance. The Assistant Supt. understands and administers the HITT safety program to include all subcontractors, ensures that all accidents/incidents… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …updates on trends and material changes to senior leadershipPartner with the Risk Data Science & Analytics teams to innovate and develop solutions to enhance risk ... enhancements to risk systems & tools.Develop and support frameworks and processes for data quality assurance.Work closely with vendors that provide critical data … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. As a Manager , Drug Safety Data , you will be responsible for ... managing and analyzing safety data to ensure the ...managing and analyzing safety data to ensure the safety of pharmaceutical...+ Minimum of 5 years of experience in pharmacovigilance, drug safety , or a related field. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … safety topics for products working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will ... products ( drug and device) including signal tracking, safety data analysis, and presenting in the...author safety aggregate reports as needed. The Manager , Drug performs medical analyses for risk… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality function ... and is a bridge between departments, CMOs and sites respective to Combination Drug Products and Medical Devices. This position performs the function of Independent… more
- Pfizer (New York, NY)
- ** Manager Data Sharing & Disclosure** +...of disclosure deliverables and assist in gathering metrics for drug programs within their remit. They will also be ... The Data Sharing & Disclosure Manager , requires excellent project management skills coupled with knowledge of clinical trials, including but not limited to,… more
- RWJBarnabas Health (West Orange, NJ)
- …Quality and Safety programs including medication-use, medication error, adverse drug reactions, and continuous quality improvement data . Identify needed ... Medication Safety Manager - West Orange, NJReq #:0000163184...respiratory therapists, medical students and physicians). + Manage medication safety issues caused by drug shortages, replacement… more
- Pfizer (New York, NY)
- …and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... to patients around the world. **POSITION SUMMARY** As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide to support drug development processes and global ... developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may ... The Senior Manager , Hematology, Clinical Scientist leads in the development,...team meetings, scientific advisory boards, study steering committees and data / safety monitoring meetings; participates in collaborative activities… more
- Pfizer (New York, NY)
- …outputs/deliverables for each assigned IEP. Additionally, the IEP Manager /Sr Manager draws from foundational knowledge of the drug development lifecycle ... support regulatory, launch, and post-launch strategy. The IEP Sr Manager is a member of the IEP Success team,...according to plan and informs IEP Director as new data or information becomes available to consider for review… more
- AbbVie (Florham Park, NJ)
- …strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to characterize the safety profile of ... and development organization. Specific areas of work may include clinical trials, patient safety , and global medical affairs. The Manager works independently in… more
