- Merck & Co. (Rahway, NJ)
- … Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to ... role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research Associate)- Manager… more
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor… 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 Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… 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. (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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. 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
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project manage GCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Eisai, Inc (Nutley, NJ)
- …timeframes and to assure consistency of case records and documentation .Responsible for evaluating, tracking, documenting and processing adverse event reports ... procedures, standardization of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information… more
- Eisai, Inc (NJ)
- …Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' ... 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)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- BioAgilytix (Durham, NC)
- …life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects ... product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agenciesCoordinates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... and approval of standard operating procedures and any other required documentation . Collaborate with functional departments to resolve issues. Perform tasks in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Eisai, Inc (Nutley, NJ)
- …Additionally, you manage regulatory compliance activities, maintain accurate documentation , and evaluate new system impacts. Organizational management involves ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Aequor (Newbury Park, CA)
- …- both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory ... and execution of the preparation, delivery and electronic archiving of documentation for inclusion in regulatory submissions. Coordination and execution of… more
