- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies, ensuring a focus on an outstanding end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor ... or university)- Bachelor's Degree required Experience Qualifications- 7 or More Years Related systems experience required- 7 or More Years Expert knowledge and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business… more
- Merck & Co. (Rahway, NJ)
- …molecules, including laboratory techniques for chromatography and filtration systems .Hands-on experience in small-scale laboratory downstream process .Deep ... the Bioseparation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late-stage pipeline… more
- Merck & Co. (Rahway, NJ)
- …a focus specifically on the Talent area. -The position will work closely with Process and Solutions leads within Human Resources Technology as well as the Global ... of the Workday application as well as support vendor systems . They will also assess and manage new demands...impact of bi-annual system updates. Serves as subject matter expert to consult with end-users on appropriate system processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for CDO & Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.) Establish and manage ... their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning...or on-site) prior onsite monitoring experience an added plus Expert in ICH-GCP principles and the application of those… more
- Merck & Co. (Rahway, NJ)
- …Candidate must have an in-depth understanding of cell biology/molecular biology/ systems biology and hands-on experience of molecular techniques, synthetic biology ... data collection and management Primary Responsibilities: Serve as the subject matter expert in cell line development and technical lead to represent functional area… more
- Merck & Co. (Rahway, NJ)
- …business outcomes-focused IT organization, and will partner with other Technical, Systems , and Solutions architects.-- - A partial list of responsibilities includes ... requirements within information, data, and analytics.- Act as a Subject Matter Expert to the organization for all data related capabilities.- Facilitate with… more
- Merck & Co. (Rahway, NJ)
- …IT organization. The position will work in tandem with other Technical, Systems and Solutions architects across the company.A partial list of responsibilities ... drive EA Governance for these special programs.Act as a Subject Matter Expert to the organization for these special programs related capabilities.Work closely with… more
- Merck & Co. (Rahway, NJ)
- …The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development, ... chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. - Mentors new team members and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team to ensure vendor compliance with all quality/safety requirements; educates on process requirements Partners with compliance and Program Management team on build ... and design of programs Expert in identifying and reporting adverse events, product technical...requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding… more
- Merck & Co. (Rahway, NJ)
- …critical non-pipeline activities in support of clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Insmed Incorporated (New York, NY)
- …in appropriate prescribing and improved patient outcomes.Field therapeutic area expert demonstrating high scientific knowledge and competency of Insmed therapeutic ... and education to health care customers within managed markets/healthcare/payor systems , in addition to other unique healthcare influencers.Full support and… more
- Merck & Co. (Rahway, NJ)
- …brand strategies for assigned TAsProvides a solid understanding of how countries' medical systems and standards of care need to change to accept new innovation, how ... with a single global scientific communications platformDrives global, regional and key country expert input events (advisory boards and expert input forums) to… more
- Merck & Co. (Rahway, NJ)
- …understanding of the strategic elements of drug development. As a subject matter expert , the Director within the QP2-IO Group will work closely with teams of ... and decisions of drug development teams. Primary Responsibilities: Serving as an expert representative for QP2 -IO on Oncology development teams. Framing critical… more
- Merck & Co. (Rahway, NJ)
- …elements of drug development and effective communication skills. As a subject matter expert , the Associate Director within the QP2-IO Group will work closely with ... decisions on drug development teams. Primary Responsibilities: Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved ... FDA databases. This individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant...and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements to prepare for launch, development and/or life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to ... inform a health systems strategy to ensure system level acceptance and access...their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for NACD & Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.) Establish and ... and they understand their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning and aspiration plans… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC,...planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring… more
- Merck & Co. (Rahway, NJ)
- …bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the related smaller scale potent development ... supply facility.Experience with small molecule drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Familiarity… more
