- Merck & Co. (North Wales, PA)
- …related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, for process ... functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, -CSRM to develop and implement mitigation plans for… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key our Company functions.Represent Device… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and global human health. The Associate Principal Scientist, Clinical Trial Analysis and Reporting leads the statistical programming activities for multiple and/or… more
- Merck & Co. (Rahway, NJ)
- … requirements, internal standard operating procedures, and external regulatory requirementsEvaluates appropriateness of available software for planned analyses ... analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.- -Participates with management in discussions with… more
- Merck & Co. (Rahway, NJ)
- …for companion diagnostics development including cut point selection and bridging analysis for regulatory approval.Interacts with Discovery and Translational, ... as companion diagnostics. The position is also responsible for supporting regulatory filing related to oncology biomarkers. -This position requires solid statistical… more
- Merck & Co. (Boston, MA)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis , regulatory filing, and publication.Specifically, the Executive Director ... and Investigational New Drug applications.Providing clinical development support of business development assessments of external opportunities to grow the Immunology… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects. -Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (Rahway, NJ)
- …drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Merck & Co. (Rahway, NJ)
- …for knowledge and life-cycle management of the program to support regulatory filings.Required Experience and Skills:Extensive experience in analysis of ... Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality, and Commercial-facing Partner Groups to support commercialization… more
- Merck & Co. (Rahway, NJ)
- … analysis and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The ... Principal Scientist will work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA… more
- Merck & Co. (North Wales, PA)
- …team leadership role to coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirementsTake a ... in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics… more
- Merck & Co. (Lower Gwynedd, PA)
- …is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis , and visualization, and automated liquid handling. The successful candidate ... leverage automation technologies across assay development, support, and data analysis . A strong, solution-focused scientific background is critical. Preferably, the… more
- Merck & Co. (North Wales, PA)
- …safety, as applicable. Coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirementsDesign, ... in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and user interfaces.Supporting project teams in creating SDTM deliverables for Analysis and Reporting activities and submission.Collaborating with project teams to… more
- Merck & Co. (Durham, NC)
- …and operational challenges.Decisions are guided by policies, procedures and business plan; receives guidance from manager.Provides planning and scheduling guidance ... as a liaison between Engineering, Maintenance, Production and other Site Business PartnersPrepares maintenance work in advance of execution to ensure parts… more
- Merck & Co. (Rahway, NJ)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... lifecycle, as well as responding to agency questions.-Scientific Excellence and Regulatory Influence:Promoting our company's scientific excellence and regulatory … more
- Merck & Co. (Rahway, NJ)
- …and tactical decision making. We use state-of-the-art techniques for financial analysis , planning, accounting, reporting, and performance evaluation. This allows the ... with stakeholders across the Finance organization, helping to solve vital business needs for Finance by leveraging data analytics and understanding implications… more
- Merck & Co. (Rahway, NJ)
- …sheet, the quality of the financial information provided to investors and regulatory bodies, and the relevance of the financial information and advice provided ... and the SEC 10Q and 10K filings. This will include compiling comparative analysis for consolidated Balance Sheet, Income Statement, and Statement of Cash Flows for… more
- Merck & Co. (Lower Gwynedd, PA)
- …team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis , and visualization, and automated liquid handling. -The primary role ... assay development, qualification/validation, technology transfer, and/or troubleshooting to meet regulatory expectations for validation and line of sight for… more
