- Genmab (NJ)
- …Data Quality Management , is a strategic leadership role within Clinical Data Management . This individual is accountable for driving the strategy, quality, ... data quality reviews and analytics.Collaborate with clinical and data management teams to interpret discrepancies and...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across Daiichi Sankyo programs.- Is responsible for management of laboratory data management full-time and/or contract staff including planning resource ... around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Contract Assessment Model (CAM) to drive and inform data driven decisions from Pricing Committee. Incorporates learnings from prior deals into forward ... to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts… more
- Genmab (NJ)
- …at least one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker ... by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data ...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to explore key market access topics of interest and generate holistic real-world- data -based strategic insights in order to provide tactical guidance to MAPA teams… more
- Repligen (Waltham, MA)
- …initiatives by maintaining contract compliance and best practices.Executive level contract reviewsRisk Management & General Legal Support Identify and ... of commercial agreements.ResponsibilitiesEmployment Law & Compliance Advise HR and management on employment law matters, including hiring, terminations, discrimination,… more
- Genmab (NJ)
- …Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust ... delivery for all stages of global feasibility. Ensure standardization in use of data , tools and processes to inform risk-benefit decision making at TA, program and… more
- Merck & Co. (Rahway, NJ)
- …development, generate experimental designs, execute experimental plans , and interpret data . - Support internal capability development by evaluating new technologies ... Design of Experiments for new chemical entities or life cycle management opportunities. - Coordinate development activities with process chemistry, preformulation ,… more
- Genmab (NJ)
- …is responsible for ensuring integrity, consistency and adherence to Study Data Tabulation Model (SDTM) standards, perform sponsor oversight of relevant programming ... activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality… more
- Genmab (NJ)
- …scope. The Programming Manager will work with other functions including Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational ... by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data ...Research, Medical Writing, Project management , and Regulatory. Responsibilities/tasks - including but not limited… more
- Merck & Co. (Durham, NC)
- …and key performance indicators. Benchmark performance indicators against industry data . Look for continuous improvements opportunities RESOURCE MANAGEMENT : ... equipment qualification.Obtains bids, reviews contracts, supervises, and follows-up on contract work including.Actively participates in, contributes to, and completes… more
- Aequor (Thousand Oaks, CA)
- …of role and responsibility Knowledge and skills: Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical ... the Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post...MD/DO or international equivalent plus 3 years relevant work Contract start date: 02Jun2025 (or earlier, if the candidate… more
- Genmab (NJ)
- …and use of Genmab's products for appropriate patients Demonstrates effective time management by focusing efforts on engagements that drive brand value, prioritizing ... account communication preferenceso Demonstrates the ability to analyze key market data points and action insights into effective business planning Develops strong… more
- Merck & Co. (Rahway, NJ)
- …regulatory filings.Design, plan, and execute laboratory experiments to generate high quality data .- Perform data analysis and ensure results are reported clearly ... bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).-Author required regulatory and technical documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is at or near target levels by managing the day-to-day relationship with Contract Management Organizations (CMO's), internal DS plants and DSI's Forecasting ... around rare diseases and immune disorders. Summary Through leadership and management of supply planners and processes, responsible for ensuring that inventory… more
- Merck & Co. (Rahway, NJ)
- …cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).-Monitor cell bank process performance across programs, ... support timeline creation and management of work packages within project teams. Monitor and project resource needs to support technical work packages and on time… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 - ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the… more
- Merck & Co. (Durham, NC)
- …ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist ... Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management ). Lead Periodic Business and Operations Review Meetings (with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors, system providers, and validation partners to ensure compliance, contract fulfillment, and service excellence.Oversee global project budgets to ensure ... technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- Repligen (CA)
- …strategic sales plans to meet and exceed sales targets.Customer Relationship Management : Build and maintain strong relationships with key accounts, including ... biopharmaceutical companies, research institutions, and contract manufacturing organizations.Market Analysis: Conduct market analysis to identify new opportunities… more
