- Merck & Co. (South San Francisco, CA)
- …timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery ... biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical pharmacology support for… more
- Insmed Incorporated (San Diego, CA)
- …and fostering compliance with ICH E6 Guideline for Good Clinical Practice.Provide support and coaching to other staff members to develop additional quality ... by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their… more
- Merck & Co. (Rahway, NJ)
- …Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as ... supplies information at Investigator Meetings for assigned protocols. - Support the collection of clinical suppl y...studies . - Mentors new team members and supports staff development, as needed - Demonstrates high capability to… more
- Merck & Co. (Rahway, NJ)
- …cost estimates requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities ... to support critical CMC activities. - - Support the collection of clinical supply chain...of expertise. - Mentors new team members and supports staff development, as needed. D emonstrates high capability to… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …NNI approved clinical studies and the skill to engage customers (prescribers, support staff , pharmacies) with fair balance on proper placement within the ... Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts,… more
- Merck & Co. (North Wales, PA)
- …is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Merck & Co. (Rahway, NJ)
- …a secondary focus on FLEx Sterile2, currently in project phase via GES.- Provide support of the mechanical aspects of clinical operations, including support ... Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily… more
- Eisai, Inc (Exton, PA)
- …Upstream and Downstream production staff in the operation of equipment to support preclinical and phase I to III clinical trials. Supervise change-over ... operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre- clinical ...downstream suites, equipment, staff and infrastructure can support manufacture of materials for global clinical … more
- Merck & Co. (North Wales, PA)
- …scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position ... general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The...and may lead a group of statistical or programming staff assigned to a development project as needed. More… more
- Merck & Co. (Rahway, NJ)
- …The applicant will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late ... Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other company Research Laboratories Scientists in… more
- Novo Nordisk Inc. (Olathe, KS)
- …health centers, HCPs and other stakeholders in a given geography. Utilizing approved clinical resources to support provider efforts to deliver appropriate care ... education and awareness across the ecosystem Work with office staff to pull through benefits verification processes Support...the elevated CV risks associated with type 2 diabetes Support branded messaging when appropriate Clinical Addendum… more
- Merck & Co. (Rahway, NJ)
- …change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Merck & Co. (North Wales, PA)
- …Development Statistics, BARDS, is responsible and accountable for the end-to-end statistical support for a number our company's late-stage products in Oncology. The ... President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction… more
- Merck & Co. (North Wales, PA)
- …is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes ... : This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… 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 ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …within the assigned geographical territory through high level scientific support for research activities, publications, education, consulting, and other Medical ... team. Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action for commercial… more
