- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position,...you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... scientific -pl anning and execution of one or more clinical trials or significant aspects thereof . In this...you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate ... Skills: strong knowledge of the principles of project management and clinical customer relationship management. - Technical Proficiency: familiarity with… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Skills: strong knowledge of the principles of project management and clinical customer relationship management. - Technical Proficiency: familiarity with… more
- Eisai, Inc (Nutley, NJ)
- … regulatory standards and guidelines for the conduct of clinical trials. Demonstrated ability to operate and influence decision-making processes Effective ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible… more
- Eisai, Inc (Nutley, NJ)
- …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 (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.Health Authority Interactions: Leads US ... academic training and job experience.Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas.Ability to travel up to… more
- Merck & Co. (Rahway, NJ)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase ... scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key company functions.Lead the ... high-quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position,...will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team.… more
- Merck & Co. (Rahway, NJ)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Genmab (NJ)
- …regulatory submissionsExperience directing multiple complex projects/studies in a technical capacityProven performance in earlier role/comparable roleFor US based ... join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional ... implantable, ophthalmic, and inhaled dosage forms.Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders,… more
- Formation Bio (New York, NY)
- …and medical imaging libraries Demonstrated ability to collaborate with radiologists and clinical teams to translate medical insights into technical solutions ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability ... the operational planning and execution of one or more clinical trials. In this position, you will have the...have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.ResponsibilitiesSupport ... ensure no overdue CAPAs.Conduct document audits including, but not limited to Common Technical Document (CTD), Clinical Study Report (CSR) and Nonclinical Study… more
