- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned ... disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and execution of clinical studies...study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides input on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and… more
- Merck & Co. (Rahway, NJ)
- …interfacing with scientists who are manufacturing drug substance to enable early clinical studies , scaling up new chemistries, and exploring new technologies. ... Job Description Position Description: Associate Specialist - Operations Support The...substance to supply material for both development work and clinical studies in our kg scale (Prep… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...NACD and Novo Nordisk (eg, across NACD, CMR, International Operations (IO), HQ R&D and Commercial). Provides excellent customer… more
- Merck & Co. (Rahway, NJ)
- …our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and ... high-quality data to assist decision making in clinical trials.This position supports statistical programming activities for multiple...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications ... and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global... Director. The team is part of the Global Clinical Development organization and has oversight over drug development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionBiologics Process R&D Associate ScientistOur Research Scientists are our Inventors.- Using innovative thinking, state-of-the-art facilities, and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Merck & Co. (Rahway, NJ)
- …in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation ... for licensure and commercialization.Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with ... management, placement and delivery to US and CA warehouses operations for US and CA Clinical Trial.../ device management) Responsible to ensure timely availability of clinical study materials and ancillary supplies to… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but… more
- Merck & Co. (Rahway, NJ)
- …interfacing with scientists who are manufacturing drug substance to support early clinical studies , scaling up new chemistries, and exploring new technologies. ... responsibility. The Specialist -Engineering position will report to the Associate Director, Engineering and will be a member of...members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility and speed… more
- Merck & Co. (Rahway, NJ)
- …supports our company's oral and sterile product portfolio through preclinical studies and modeling. The responsibilities include advancing a culture of scientific ... modalities and designing corresponding patient centric drug products through Phase 3 clinical development and line of sight to process validation and commercial… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Clinical Operations ...as well as overall day-to-day operations of clinical studies , ensuring study information ... studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative...Associate Director (AD) is responsible for ensuring assigned clinical studies are delivered within timelines, budget,… more
