- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Merck & Co. (Rahway, NJ)
- …for understanding business opportunities, outcomes and execution.The DSCS Digital Program Manager will:-Work with the DSCS Digital Leadership Team , workstream ... achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical...commitment to innovation and to our people. As a team , we commit to creating a culture of diversity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member ... with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical… more
- Merck & Co. (North Wales, PA)
- … team .Job Responsibilities: Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s). This may include:Serving as ... the lead clinical scientist on a clinical trial team .Leading medical monitoring team...study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection… 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 ... The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability;...(subset of) NACD and/or as part of a global team and as aligned to a business case, goals… more
- Novo Nordisk Inc. (Phoenix, AZ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability;...(subset of) NACD and/or as part of a global team and as aligned to a business case, goals… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...monitoring, interpreting and communicating key regulatory developments within CQO. Team up with other therapeutically aligned CQOM to provide… more
- Merck & Co. (North Wales, PA)
- …clinical trial team .Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... direction of the Program Lead, you will collaborate with global, cross- functional team -members including clinical directors and study managers to lead/support … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team , provide programming supports in agency response or potential ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...within North America Provides operational direction to the trial team according to agreed strategy and plan, optimizing speed,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI)...all of these activities when needed to support the team , including but not limited to processing of serious… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development… more
- Novo Nordisk Inc. (Cincinnati, OH)
- About the Department The Diabetes Sales Team leads the US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class ... reduction of adverse cardiovascular events. As part of the team , you will have frontline exposure to our portfolio...you ready to realize your potential? The Position The Manager - Pharmacy Execution will work with Regional Business… more
- Insmed Incorporated (Bridgewater, NJ)
- …do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the ... 2022, and 2023Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science 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 ... personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and… more
