- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and ... impact in achieving those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... you ready to make a difference? The Position Supports the North America Clinical Development (NACD) Clinical Research Equity (CRE) strategy integrating diversity… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects and ... collaborate with our Research & Development Division colleagues from Global Clinical Development, the Center for Observational and Real-World Evidence, Global… 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
- Aequor (New York, NY)
- …over 100&plus markets. The candidate will also serve as the core project manager for the Pneumococcal GASP team. Collaborates with cross-functional team members to ... and tools in health services research is required, eg, literature review, clinical data interpretation and claim data analysis Knowledge of data science desirable… 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)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses ... in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Tris Pharma (Monmouth Junction, NJ)
- …team success.We have a position in Monmouth Junction, NJ for a Contracts Manager /Paralegal to join our small, but experienced, in-house Legal team.The Contracts ... Manager /Paralegal supports the Legal department in the review, drafting...and agreements (ie, NDAs, service agreements, supply, sales and clinical vendor agreements, etc.) Experience handling multiple aspects of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key… more
- Eisai, Inc (Nutley, NJ)
- …with a minimum of 6 years proven pharma industry experience in clinical development statistical programming methods & processes is required.In depth experience as ... a statistical programmer within the clinical development function of a therapeutic area(s). Ability to effectively follow instructions and work under… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within specified therapy area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within specified therapy area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of pharmaceutical product development processes, including clinical development, regulatory pathways, and commercialization strategies, especially ... within diabetes, obesity, cardiovascular diseases preferred Experience with local and global operations within life sciences preferred Proven track record of successfully managing complex portfolios of assets and indications, with demonstrated ability to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
