- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Merck & Co. (Rahway, NJ)
- …oversight and supervision of the TA-Head or CRD.Requires understanding of local regulatory environment.Scientific and clinical research knowledge is ... Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology...for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management… more
- Novo Nordisk Inc. (Atlanta, GA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical studies, knowledge of drug development phases, statistical research methodology experience) Leadership skills; project management skills; effective ... in the assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development. Internal relationships include working with… 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 ... applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products Create and maintain product/ project database to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, (2) determine the implications for cross- project strategy, and (3) coordinate pre- clinical / clinical research plans to progress the strategy with keen ... will have responsibility to incorporate translational research plans into clinical protocols and ensure proper documentation and regulatory compliance.Help… more
- Merck & Co. (Rahway, NJ)
- …imaging tools, and data analy sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: ... Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting...novel technologies - through active collaboration with cross functional project teams and external vendors. Designing scientific studies to… more
- Tris Pharma (Monmouth Junction, NJ)
- … Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, ... Operations and Project Management areas ensuring ability to meet clinical , regulatory and business objectives through efficient completion of delegated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... mitigation plans to management and other internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions,… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Merck & Co. (North Wales, PA)
- …SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written ... Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Merck & Co. (North Wales, PA)
- …DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our company. Position Description/Summary The Senior ... Specialist, Project Manager is a core member of Early Drug...integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryLeadership responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop ... PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological...all phases of studies and participates in KOL and regulatory interactions at a project level, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory , ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Executive Director,… more
