- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs...and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe primary function of the Clinical Research Associate (CRA) I position is to assist with clinical study operations as well as monitor ... be conducted in compliance with the requirements of Good Clinical Practice (GCP).The Clinical Research Associate I...Forms, in collaboration with other CRAs and the Data Manager .Organize the shipment and submission of study materials and… more
- ACROBiosystems Inc. (New York, NY)
- …proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening ... and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are...and e-mails as appropriate. Work with the Regional Sales Manager to develop and execute territory sales plans. Extend… more
- Aequor (Piscataway, NJ)
- Two new Regulatory Manager requisitions are about to go live in the system; one based in Princeton, NJ, and the other in San Diego, CA. Job Title: Regulatory ... Publishing Manager I Duties The Manager /Sr. Manager...by advising on use of Veeva Vault RIM. For clinical study reports, deliver Regulatory Operations kickoff slides (covering… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise in addressing technical challenges in the programming ... Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate… more
- Lundbeck (Queens, NY)
- …lives. Join us on our journey of growth! As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional ... centers and hospitals, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Neuroscience Account Managers… more
- Lundbeck (Queens, NY)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.ResponsibilitiesSupport audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with ... and marketed products; required4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) required4 or More… more
- Eisai, Inc (Nutley, NJ)
- …and drug development plans within the clinical development. Works with the clinical , project management, and data manager teams on strategic designs of ... we want to hear from you. This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses ... in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Novo Nordisk Inc. (Jersey City, NJ)
- …Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, ... the Specialty Field Sales Representative reports to the District Business Manager of the specific sales territory. The Specialty Field Sales Representative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... dynamics driving the US health care environmentSelf-starter with strong clinical acumen, solutions oriented and can function autonomously.Open, collaborative nature… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- RWJBarnabas Health (New Brunswick, NJ)
- Clinical Manager (RN) - Renal TransplantReq #:47591 Category:Leadership Status:Full-Time Shift:Day Facility:RWJ New Brunswick Department:Organ Transplants Pay ... One Robert Wood Johnson Place, New Brunswick, NJ 08901 Job Title: Clinical Manager Location: RWJ New Brunswick Department: Organ Transplants Req#: 47591 Status:… more
