- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) ... with-ICH/GCP and country regulations, Our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Merck & Co. (Rahway, NJ)
- …sharing best practices as appropriate/required. Core competencies: Expertise of core clinical systems , tools and metricsExcellent verbal and written influencing ... and insurance process management. Enters and updates country information in clinical and finance systems .Ownership of local regulatory and financial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt...experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in … 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; ... Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of clinical trial management systems and archiving systems . Relationships Reports to a Manager (or above) within NACD. Manages mutually ... all relevant services/tasks in support of the planning and quality delivery of clinical trials in line... clinical trials, including distribution of SUSARs to clinical trial sites Maintenance of systems , eg,… 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...experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations,… more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell… 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)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... 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… more
- Aequor (Thousand Oaks, CA)
- …of a driving range of Thousand Oaks. Some qualities that stand out to the hiring manager on resumes is: Looking for candidates who can be viewed as the top end of ... hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will...ability to do the right thing (ethics). The hiring manager needs a candidate with the ability to be… 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 ... in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process owners that… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....case processing and NNI contracting operations including tool and systems used, exceptions processes, and workflows Collaborates with all… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...management of shipments, ensuring timely and accurate deliveries.Implement tracking systems to monitor the progress of shipments and address… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
