- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead… 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
- 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
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... 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)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. ... study reports, or publication Participation in internal and joint internal/external research project teams relevant to the development of new compounds… more
- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... writing, and presentation skillsExperienceBachelor's degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field… more
- Daiichi Sankyo, Inc. (Bernards, 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
- 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
- Daiichi Sankyo, Inc. (Bernards, 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....governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory … 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
- 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 ... to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing and executing...number of stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will… 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
- Merck & Co. (Rahway, NJ)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Job Description Job Description: - The drug development Project Manager is part of Global Project... and Alliance Management (GPAM) which sits in the Research & Division organization of our company. - Position… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in the ... external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
