- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic ... study reports, or publication; and Participating in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- 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
- 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
- Merck & Co. (Rahway, NJ)
- … Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology ... Clinical Research group and in the field...study reports, or publicationsParticipation in internal and joint internal/external research project teams relevant to the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a growing ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director, Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience in managing/monitoring clinical research sites (in-house or on-site) prior onsite ... About the Department The Clinical , Medical and Regulatory (CMR) department...Nordisk (eg Investigators and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and… more
- Merck & Co. (Rahway, NJ)
- …development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these ... biomarker assays across all therapeutic areas and all phases of clinical development within our company's research laboratories. TMB laboratories leverage… more
- Merck & Co. (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive ... systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory knowledge,… more
- Genmab (Plainsboro, NJ)
- … project teams Prepare/oversee/review/maintain regulatory documentation (eg regulatory sections of clinical applications, marketing applications, Health ... will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned project /projects) to advance Genmab's… more
- Genmab (Plainsboro, NJ)
- …to: Act as US regulatory lead and FDA contact person for assigned project (s) and be responsible for the implementation and maintenance of the US regulatory ... to ensure optimal regulatory success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other… more
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assets May serves as the senior liaison for relevant stakeholders in the ... Payers, Regulatory Agencies) Responsible for managing, coaching, and mentoring Clinical Directors and developing the next-level talent pool within the CV&R … more
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assetsMay serve as the senior liaison for relevant stakeholders in the ... external community (Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors 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, ... and help teams prepare for governance interactions. Independently manage interactions with clinical leads, data management, safety, regulatory , and QA team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… 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 ... will interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy &… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Genmab (Plainsboro, NJ)
- …collaboration (ie, project /program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in relation ... as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project /Trial ManagementObtain Project /Trial specific information… more
- Genmab (Plainsboro, NJ)
- …demand, manage inventory, and prevent stockouts.Lead cross-functional collaborations, including Clinical Project Supply Team discussions.Change and Stakeholder ... technical skill development.Oversee resource allocation and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to) Clinical Development, Global Medical Affairs, Biostatistics, Clinical Pharmacology, Regulatory , Marketing and Market Access. Work with cross ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Research and Development Drug Processes. Prior experience in project management or project management software such… more
