- Daiichi Sankyo, Inc. (Bernards, NJ)
- … setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of ... reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to identify, generate and execute… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management… more
- Merck & Co. (Rahway, NJ)
- …dataTo compare the two independently entered data ("confrontation") and collaborate with Clinical Research Manager (CRM) to resolve -data entry differencesTo ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and… more
- Merck & Co. (Rahway, NJ)
- …testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, ... we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating...Developer who will be instrumental in creating and developing clinical databases and data transfer files. This role provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near real-time… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...§ 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% Occasional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications- Eight (8) plus years of pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in a regulated ... GCP environment or equivalent experience preferred- Experience in Clinical Safety and Pharmacovigilance preferred- Medical Affairs experience preferredTravelAbility… 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...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs ... facility (inclusive of RY119) supports the formulation and filling of clinical , stability, and developmental Sterile, OSD and Inhalation supplies. These facilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to… more
- Novo Nordisk Inc. (New York, NY)
- …The Rare Bleeding Community Liaison Leader is an influential first-line people manager for a team of patient-facing employees. They are responsible for effectively ... Community Liaison Leader is expected to possess a high level of clinical and customer knowledge. They should also understand and execute against headquarter… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key ... maintenance process. The outcome of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can set the right priorities.After… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed may… more
