- Merck & Co. (North Wales, PA)
- …the protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as team ... functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ ... primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network.… more
- Genmab (Plainsboro, NJ)
- …purpose.Genmab is looking for a dynamic, science-driven people leader to head our Clinical Pharmacology & Quantitative Sciences team. Do you get excited by our well ... innovation powerhouse. The RoleYou will act as functional leader of our Clinical Pharmacology & Quantitative Sciences (CPQS) group, currently consisting of 25+… more
- Legend Biotech USA, Inc. (Charlotte, NC)
- …plans.The CTCE will determine how to best engage customers and accounts, monitor the changing market educational needs/ clinical trends, and compliantly ... the treatment of multiple myeloma.Legend Biotech is seeking a Senior Cell Therapy Clinical Educator as part of the Commercial team based in the Carolina's territory… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... you will play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In addition, this position… more
- Insmed Incorporated (San Diego, CA)
- … Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor (s) for assigned protocols and/or ... with vendors and cross functional teams. The Senior CRS will provide clinical and scientific support to clinical development and operations, regulatory,… 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 ... manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to… more
- Merck & Co. (Rahway, NJ)
- …technical solutions with the highest value, that improves the way we run our clinical trials for our patients, our partners, and our employees.Candidate will have a ... and innovation to:Invest in data that fuel innovationModernize our current state clinical technology and business processes by implementing a new unified clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Genmab (Plainsboro, NJ)
- …market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross functional teams.We have a ... internal and external venues including the US/Global cross-functional teams, clinical development teams, advisory boards, steering committees, professional society… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company objectives, ensuring alignment between marketing, medical and market access Monitor financial performance metrics, ensuring revenue targets are met or ... reporting on the effectiveness of Rare Bleeding marketing strategies and initiatives Monitor and evaluate key performance indicators (KPIs) and metrics to track… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late-stage clinical ... in the review and analysis of quarterly financial results against plan and monitor key changes between current forecasts vs. prior forecast or year over year… more
- Genmab (Plainsboro, NJ)
- …regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for ... participate in meetings with FDA and other health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and current… more
- Merck & Co. (Lower Gwynedd, PA)
- …IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. ... neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This ... requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Genmab (Plainsboro, NJ)
- …US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned ... Data Sheep and US Prescribing Information. Responsible for maintenance of the IND. Monitor and assess global and US regulatory guidelines and regulations and current… more
- Lundbeck (Rockford, IL)
- …Skilled Nursing Facilities.You will drive demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local ... develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing scenarios and strategy for all pipeline products starting in Phase II clinical trials Leads assessment of investments in payer contracts and patient copay ... with key accounts and the managed markets overall Liaise with PCOR to monitor the existing deals - comparing actual results against projected KPIs and developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compelling plans and recommendations for management endorsement Insight generation: Monitor and assess program effectiveness; implementing data driven improvements ... of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans, forecasting, and… more
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