- 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
- 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. (San Antonio, TX)
- …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
- 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
- Merck & Co. (Rockville, MD)
- …with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a ... interactions and communications with trade associations and health authorities on regulatory policy matters.Participating in regulatory project teams… 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
- 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)
- … 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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... team to ensure adequate and appropriate resourcing for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO)… 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
- 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)
- …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)
- …and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical data ... 2+ years' experience in project management or 5+ years' experience in project management.2+ years' experience working in clinical development or clinical … 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
- 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)
- …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)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific… more
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