- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource...are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a … more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... Clinical Research and Pharmacovigilance team push the boundaries of...for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to… more
- Novo Nordisk Inc. (Atlanta, GA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... external partners relevant to the planning and implementation of clinical trials and improvement /innovation projects for NACD...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships with external partners relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and Novo Nordisk ... internal stakeholders relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and...all relevant services/tasks in support of the planning and quality delivery of clinical trials in line… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement , error… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... systems records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Validation with the goal of creating a culture shift to data-driven data quality . This position requires working knowledge of clinical data management processes, ... strategy. This role will assist in driving the connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data… more
- Catalent (St. Petersburg, FL)
- …for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval ... QA Product ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Lundbeck (New York, NY)
- …the way in creating positive customer experiences!As a Biopharmaceutical Area Sales Manager (BASM) you will be responsible for leading, developing, and managing a ... Others Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …[QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure ... and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement ...in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality … 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-level marketing ... and other materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality control of… more
- Catalent (Manassas, VA)
- …site and across the company. Leads site-level initiatives for supplier management, supplier quality & supplier performance improvement as well as supports global ... help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tasks at all times Provides strategic input and contributes to process / quality improvement initiatives Guides the successful completion of major programs or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …timeline and KPIs, overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant. Serve as the ... immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
