- Merck & Co. (Rahway, NJ)
- …strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required. Strong understanding of clinical ... ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. JOB SUMMARYThe Director, Clinical Project Management will manage assigned project (s), including program's ... to development plans and corporate objectives. Advanced understanding of clinical research and the clinical ...PMP is desirable. Minimum of 12+ years' experience in clinical project management; deploying project … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department...support and technical assistance during preparation and review of regulatory documents As assigned, participate in project … 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
- 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
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds… 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 ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in a medical ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key company functions.Represent ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies production… 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)
- …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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …data is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse ... what matters. -As Research and Development IT continues the transition from project / portfolio-based execution to the product model, it is important to have an… 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)
- …as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....around rare diseases and immune disorders. Summary The Director, Clinical Safety, will be a product safety lead or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our ... methodology, we collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Research & Development… 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
- 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
