- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …often handling straight-forward CSPV tasks such as single event level AE causality assessment . This position requires manager review and gains industry knowledge ... Signal Identification: Carries out routine signal identification activities formulated by manager . Uses medical knowledge to aid the SMT's signal identification… more
- Novo Nordisk Inc. (Atlanta, GA)
- …fulfil regional account targeting strategy requirements Manage district customer needs assessment . Apply assessment frameworks against accounts in district ... region by overseeing OCS account assessment activities. Identify program/service requirements for addressing needs. Work with the VP Obesity Sales, Field Sales,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... training and onboarding, metrics activities, participate in GCO vendor assessment , and tracking od vendors and assessment ...vendor assessment , and tracking od vendors and assessment status. In addition, this role will support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead ... statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO… more
- Eisai, Inc (Nutley, NJ)
- …regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of medical information obtained or related to adverse event reports, ... cumulative reports, or international regulatory reports and requests. 20%Set standards for data collection and distribution processes; coordinates with others to assure policies are implemented. Assures regulatory and internal timeframes for the processing of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company policies.Procurement - Manages all Outsourcing activities from vendor assessment , RFP, selection, contract budget, payment schedule scope negotiation thru ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Tris Pharma (Monmouth Junction, NJ)
- …an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior Manager , Business ... Thorough knowledge of pharmaceutical market and experience with opportunity assessment , product development and life-cycle management strategies Demonstrated proficiency… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …objective evidence for inclusion in validation reportsAssist with the technical assessment and resolution of deviances and variances that occur during production ... or validationWork with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency auditsEnsure site/system validation program meets FDA, ISO and EU requirementsCollaborate with peers and stakeholders to in QA and… more
- Eisai, Inc (Nutley, NJ)
- …data privacy standards. Your responsibilities span security operations, risk assessment , investigations, and compliance issue resolution for the Americas business. ... Security and Data Privacy standards through continual risk and security assessment .Collaborates with global stakeholders from EIT and leaders across regions in… more
- Merck & Co. (Rahway, NJ)
- …of both internal and external resources located on and offshore; manager project in Agile (Scrum) development methodology; planning, organizing, and conducting ... assessment activity and determination whether appropriate quality control have been applied; working with Tricentis Tosca and LiveCompare; experience with Test… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …with field sales forces are accomplished. Essential Functions Regional account manager (ram) coaching: Ensure that RAMs understand their level of accountability ... and Negotiation Work with Legal and Pricing to provide detailed assessment and interpretation of key legislation including business implications, financial impact… more
- Catalent (St. Petersburg, FL)
- …schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance ... scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence;… more
- Insmed Incorporated (Bridgewater, NJ)
- …Model, Medical Expert Engagement Planning, Coaching Framework, Field Impact Assessment , MSL functional onboarding, Clinical Trial Support Framework, etcOperational ... - Create external MSL benchmarking and innovative external impact assessment capabilitiesCross-functional Alignment - Partner with Global Medical Directors, Field… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... Indirectly oversee Investigations Managers, providing guidance and support. Risk Assessment and Prioritization: Conduct risk assessments to prioritize investigations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access ... desirable preferred- Experience developing global launch pricing strategy, including assessment of optimal launch sequence, and global/regional launch price… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support, and recognition to direct reports including objective setting, mid-year assessment , year-end reviewFoster a positive work environment where different work ... work experience as a top tier management consultant, project and change manager or similar role in pharmaceutical drug development desirable. Project Management,… more
- Chatham (San Marcos, CA)
- …vendor and customer invoices, transactions, and expenses . Assist the Accounting Manager with various accounting tasks . Handle both Accounts Payable and Accounts ... in all tasks and interactions are essential MUST UNDERGO A BACKGROUND CHECK AND MUST ACHIEVE A SCORE OF 85% OR HIGHER ON THE ATTENTION TO DETAIL ASSESSMENT . more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and project teams on information security procedures. Conduct risk identification and assessment with attention to the business processes and goals. Develop and ... to protect these systems. Relationships This position reports directly to the Senior Manager , Global Security Operations - Americas and works in alignment with the… more
- UNC Health (Chapel Hill, NC)
- UNC Health is seeking a Registered Nurse (RN) Care Manager for a nursing job in Chapel Hill, North Carolina.Job Description & RequirementsSpecialty: Care ... position is to provide ongoing support and expertise through comprehensive assessment , planning, implementation and overall evaluation of individual patient needs.… more
