- Merck & Co. (Rahway, NJ)
- …for clinical supplies . Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to ... chain across the full of our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging… more
- Merck & Co. (Rahway, NJ)
- …(as a lead Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to ... clinical supply chain across the full company Research Laboratories portfolio of clinical trials .- Global Clinical Supply is accountable for the… more
- Insmed Incorporated (San Diego, CA)
- …review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor ... clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials , through to full… more
- Merck & Co. (Rahway, NJ)
- … supply chain across all of the R&D portfolio to enable the execution of any clinical trial using a company asset.-GCS supports more than 300 Phase I-IV ... clinical trials run inhouse, 400+ outsourced or...service activities to ensure supply continuity that meets our quality , compliance, and regulatory standards.Strategic collaboration with… more
- Genmab (Plainsboro, NJ)
- …trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in relation to IMP/AMPManage project/ trial specific ... Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/ Trial ManagementObtain Project/ Trial...team focused on planning and maintenance of supplies for clinical trials , working closely with the Global… more
- Merck & Co. (Rahway, NJ)
- …drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying ... regulatory requirements, the competitive landscape, and commercial considerations.Planning clinical trials (design, operational plans, settings) based on… more
- Merck & Co. (Rahway, NJ)
- …of GCP and GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory knowledge, including FDA/CVM, EMA/CVMP, ... management team in supporting the pharm and vaccine veterinary clinical trials . The ideal candidate will be...such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive… more
- Genmab (Plainsboro, NJ)
- …RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned ... to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global… more
- Genmab (Plainsboro, NJ)
- …must be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a ... Planning and Operational ExecutionOversee strategic and operational plans for clinical trial drug supply.Maintain agreements, contracts, and SOPs… more
- Genmab (NJ)
- …effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in ... various stages of clinical development (including clinical trial ...trials /compounds and participate in the development of the clinical development plan (CDP) Author components with Medical Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Genmab (NJ)
- …activities related to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director ... management activities and processes support the efficient and effective execution of clinical trials .Ensures trial related data management activities… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to regulatory correspondences relating to NDAs, ANDAs, 505(b)(2) filings, clinical trial work, in multiple jurisdictions, specifically with FDA, EU, ... in pharmaceutical / biotech / CDMO industry in a fast-paced multi-jurisdictional high- quality regulatory environment At least 5 years of progressive people… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials . This role will work cross functionally within Clinical Medical and Regulatory (CMR) to build relationships with Healthcare Professionals, ... About the Department The Clinical , Medical and Regulatory (CMR) department...research sites / Institutions to optimize the delivery of clinical trial programs across therapeutic areas where… more
- Merck & Co. (Lower Gwynedd, PA)
- …and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. ... (eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility… more
- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well as ... Research Scientist (CRS) will support and work predominately with the Clinical Trial /Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or… 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 ... Data Strategy and Evidence (CDSE) but more broadly within Clinical , Medical and Regulatory (CMR), Market Access...quality of life, or other patient-centric concept of clinical benefit Ensures the scientific quality and… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …educational workshops, round tables, medical forums, etc. May explore and identify sites for clinical trials in all stages of development. Incumbents have a deep ... About the Department The Clinical , Medical and Regulatory (CMR) department...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
