- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical ... Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Manager of Operations - Continuous Improvement and Projects as part of ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and… more
- Merck & Co. (Rahway, NJ)
- …and maintenance of financial systems. Financial forecasting in conjunction with Sr .COM /other roles.Executes and oversees clinical trial country submissions ... Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in...address and resolve issues, with minimal support from the Sr .COM or manager .Ability to make decisions independently… more
- Merck & Co. (Rahway, NJ)
- …the trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Catalent (San Diego, CA)
- …AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... compliance , and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Aequor (Piscataway, NJ)
- Job Title: Manager / Sr . Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... year Shift Type: Day M-F 9-5 Position Summary: The Manager / Sr . Manager , Medical Communications (S/MMC)...is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight...with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/ Sr . Manager Regulatory Affairs. Develop and maintain ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...projects/products/processes. Assist the Director/Associate Director in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations,… more
- Eisai, Inc (Nutley, NJ)
- …Responsibilities Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level ... training, advanced product training, improved selling skills, disease state knowledge, clinical and business acumen application of the Eisai Selling model and… 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 ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… 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 ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… 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 practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role… 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 ... material. Ensure quality control of marketing content in alignment with compliance Continued Improvement: Ensure pull-through of 'test and learn' principles by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …access strategy for the assigned oncology asset(s). This person will report to the Sr Director, Global Oncology Value Pricing & Access, and will be responsible for ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as well ... Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry....in alignment with theses and the NN WAY: Direct manager of individuals on the Government Accountability Team Physical… more
- Johns Hopkins University (Baltimore, MD)
- …investigators in the division. The Sr . Clinical Research Program Manager will be responsible for ensuring regulatory compliance , managing the day-to-day ... the implementation of research studies, including multi-center trials. The Sr . Clinical Research Program Manager ...and implement a robust quality management system to ensure compliance . + Manage and monitor adherence to local, state,… more
- University of Pennsylvania (Philadelphia, PA)
- …technology/systems required to enhance clinical research operations. In this role, the Sr Clinical Trial Project Manager will independently manage a ... of health and wellness programs and resources, and much more. Posted Job Title Sr . Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job… more
- Penn Medicine (Philadelphia, PA)
- … Ambulatory RN Department: Cardiology Location: 800 Spruce St. Summary: + The Senior Clinical Manager is responsible for consistent and comprehensive ... patient care delivery in the ambulatory practice setting. The Senior Clinical Manager is responsible... Manager is responsible for continually assessing the clinical care team to ensure quality, compliance … more
