- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - CTD submissions/Others - May ... supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety… more
- Eisai, Inc (Nutley, NJ)
- …overseeing statistical activities across a diverse portfolio. This portfolio includes studies related to Alzheimer's disease (AD) dementia and various other ... project teams. This involves providing valuable statistical input on observational studies , actively participating in the formulation of study designs and defining… more
- Eisai, Inc (Nutley, NJ)
- …medical education, research grants, medical advisory boards, and scientific communication /publication components of overall medical operating plan. The Medical ... for approval of medical and scientific content of all relevant materials/ communications . Essential Functions: Medical Affairs Strategic Plans: Work with key… more
- Eisai, Inc (Nutley, NJ)
- …medical education, research grants, medical advisory boards, and scientific communication /publication components of overall medical operating plan. Provide strategic ... for approval of medical and scientific content of all relevant materials/ communications . Essential Functions Medical Affairs Strategic Plans: Under the direction of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and internal education, publications, scientific exchange and external data communication , and stakeholder scientific engagement. Responsible for managing budgets ... as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document development… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …strategy, coordinate, and facilitate key global oncology early development studies , functional lines including, global regulatory operations, biostatics, data ... and will play a role to integrate DS FIH studies globally. The added role Network Lead is accountable...for appropriateness to join the DS FIH Site Network.Maintaining communications among the PIs, Sites, KEEs in the DS… more
- Eisai, Inc (Nutley, NJ)
- …medical education, research grants, medical advisory boards, and scientific communication /publication components of overall medical operating plan.The Sr Medical ... responsible for approval of medical and scientific content of all relevant materials/ communications .The Sr Medical Director plays an important role in helping to… more
- Merck & Co. (Rahway, NJ)
- …investigational or marketed Oncology drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in commercialization, regulatory… more
- Merck & Co. (Rahway, NJ)
- …investigational or marketed Oncology drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert… more
- Merck & Co. (Rahway, NJ)
- …trial team (CTT).Responsible for project management of the assigned studies : pro-actively plans, drives and tracks execution and performance ... COMs).Responsible for creating and executing a local risk management plan for assigned studies .Ensures compliance with CTMS, eTMF and other key systems in assigned … more
- Merck & Co. (Rahway, NJ)
- …eg generating and evaluating data). Conduct residue chemistry and metabolism studies to support domestic and international registration of pharmaceuticals in food ... guidelines on veterinary drug development for food producing animalsProficient in written communications and in the preparation of study documents for submission to… more
- Insmed Incorporated (Bridgewater, NJ)
- …HEOR leads the strategic planning and execution of HEOR evidence communication initiatives demonstrating the value of Insmed's product(s) for intended indication(s), ... including development of HEOR evidence communication tools and support training of internal teams on the use of communication tools with expertise. The Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and ... protocol amendments/deviations Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings Provide protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leader accountable for operational planning and execution of FIH, clin pharm patient studies , and Phases 1-3 clinical trials at the study and program level. ... management, and organizational skills and expert level written and verbal communication skills. The role is primarily responsible for Operational Program Strategy… more
- Catalent (Philadelphia, PA)
- …and release. The Quality Assurance Document Control manages the communication between the operations/production, project management, shipping and quality assurance ... and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to… more
- Aequor (New Brunswick, NJ)
- …to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. ... information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act… more
- Tris Pharma (Monmouth Junction, NJ)
- …We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New ... apparatus (Distek)Collaborates closely with R&D for analytical method transfer studies and other analytical method related issuesAssists with the identification… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly ... of clinical trials in line with established targets and metrics including communication of updates Responsible and accountable for tasks, processes and deliverables… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle ... GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned… more
- Tris Pharma (Monmouth Junction, NJ)
- …We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New ... incumbent contributes to the design, data collection and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and… more
