- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, ... with strict adherence to local regulations, company SOPs and ICH GCP.As line manager the role is critical to continuously develop key talents by providing training,… 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
- Alternate Solutions Health Network LLC (Columbus, OH)
- …methods to ensure patient and family understanding.Policies: Completes all clinical documentation following agency protocol and Medicare/Federal guidelines.Rules ... the order sets and goals created by the Case Manager . Interacting with patients' families while caring for your...and observe and monitor patient conditions and notify case manager of any changes in the patient's condition.Minimize Patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… 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
- 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
- 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
- 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
- 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
- Aequor (Thousand Oaks, CA)
- Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit to support site operations once a week to once a month depending ... degree preferred. Job Details: Under minimal supervision, manage demand and supply of Pre- Clinical and Phase I Clinical Programs. The position requires project… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Manager role as part of the Quality Operations team based in Raritan, New ... Jersey. Role Overview The Quality Systems Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processes Knowledge, Skills, and Abilities: ... is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Key Responsibilities ... logbooks, and records. Utilization of electronic systems (LIMS) for execution and documentation . Create, review, and approve relevant QC documents, SOP's and WI's.… more
