- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned ... DescriptionThis role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with ICH/GCP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Global Clinical Data Standards Therapeutic Area Lead The Associate Director, Global Clinical Data Standards Therapeutic ... as assigned. May participate in process design and/or implementation initiatives.-The Global Clinical Data Standards Therapeutic Area (GCDS TA) Lead is… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … more
- Merck & Co. (North Wales, PA)
- …Portfolio Lead , the core responsibility of this individual will be to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) ... CMC and Clinical strategies.- Position Description/Summary: The CIPM Senior Specialist, Project Manager, is a core member of DCTs, partnering with team leads to… more
- Merck & Co. (North Wales, PA)
- Job Description- Role Summary:The Process and Systems Lead Senior Director, Medical Operations ( Lead , P&S) is a leadership role within Global Medical and Value ... (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead .-The Lead , P&S is responsible for managing people and building optimal… more
- Merck & Co. (Rahway, NJ)
- …experience in the pharmaceutical industry (eg, Medical Affairs, Regulatory Affairs, Clinical , Pharmacovigilance).- - Required experience and skills: Project ... by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site...not apply to roles that have been designated as " remote ".Under New York State, Colorado State, Washington State, and… more
- Merck & Co. (North Wales, PA)
- …Product Manager - PV Signaling, Analytics & Reporting. Reporting into Product Line Lead Patient Safety, Quality & Compliance, this position will be responsible for ... and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory, and safety to ensure that PV processes are integrated… more
- Merck & Co. (Rahway, NJ)
- …matter expert in tissue-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Merck & Co. (Rahway, NJ)
- …matter expert in tissue-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Merck & Co. (Rahway, NJ)
- …audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert. Proactive identify, ... and approval of documentation to support Good Manufacturing Practice (GMP) - clinical supply API manufacture, testing, release, and maintenance in support of our… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The ... of Design, Detailed Design and Execution phases of the project , and will go on to support new and/or...our Company's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... work in a fast-paced job that provides a high degree of technical and project management responsibility. -This SSO Process Engineer role within the SSO Pilot Plant… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and compliant ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by… more
- Insmed Incorporated (Bridgewater, NJ)
- …understanding of advanced statistical concepts and techniques applicable to Clinical ResearchStrong project management, interpersonal and communication skills ... understanding of advanced statistical concepts and techniques applicable to Clinical ResearchStrong project management, interpersonal and communication skills… more
- Merck & Co. (Rahway, NJ)
- …organizational skills to multi-task.Desire and willingness to learn, contribute and lead . Project Management experience with demonstrated skills.Candidate must be ... a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Manufacturing Automation position will ... report to the Director, Engineering, Automation Lead position and will be a member of the...as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot… more
- Merck & Co. (North Wales, PA)
- …The goal of the organization is to ensure compliant utilization of clinical participant biospecimens to answer scientific questions across the company's pipeline, ... language and informed consent process, including, but not limited to clinical biomarkers, future use, and genetic/genomic sample collection, and disposition.- You… more
- Merck & Co. (San Diego, CA)
- …complex disease mechanisms. The Head of Precisions Genetics & Genomics will lead a bioinformatics, genetics, and machine learning team with remit to apply ... GWAS/QTL integration, Mendelian randomization, and polygenic risk scores, and/or clinical genomics.Experience in analysis of high-dimensional molecular data, such as… more