- Merck & Co. (Rahway, NJ)
- …trial data and bring innovative therapies to patients.- - As a Director, Clinical Analysis and Reporting IT Product Line Lead, you will play a critical role in ... successful implementation of the product strategy in Clinical Trial Analysis and Reporting space . You will be responsible...and Reporting product line, aligning it with the overall business objectives of the organization and our capability model.… more
- Merck & Co. (North Wales, PA)
- … 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.May represent biostatistics in regulatory interactions… 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. (North Wales, PA)
- …of management experience at the Director level.-Required Skills and Experience:- Business domain knowledge expertise including statistical analysis and ... 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)
- …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. (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. (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. (Rahway, NJ)
- …analysis requirements, internal standard operating procedures, and external regulatory requirements.Represent statistics in meetings with management in strategic ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support cGMP and regulatory compliance during microbiological method transfer/qualification and routine product testing ... microbiological laboratory proceduresProvide active support during audits and inspections ( regulatory , internal, safety)Assist regulatory groups by providing… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX), experience in microbiological… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis , regulatory reporting, and publication.Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …entire cycle of clinical development, including: study design, placement, monitoring, analysis , regulatory reporting, and publication. Specifically, the Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …and creation of the Study Data Tabulation Model (SDTM) deliverables for analysis and reporting and world-wide regulatory application submissions of drug ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting… more
- Merck & Co. (Rahway, NJ)
- …different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving ... organizational, prioritization and problem-solving skillsStay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals)… more
- Merck & Co. (Rahway, NJ)
- …indications to pursue and subsequent study design, initiation, execution, monitoring, analysis , regulatory filing, and publication. Specifically, The Senior ... and Investigational New Drug applications.Providing clinical development support of business development assessments of external opportunities to grow the Immunology… more
- Merck & Co. (Durham, NC)
- …waste building is maintained in a neat, organized manner.- Ensure regulatory compliance.GENERAL PROFILE: Coordinate the collection and transportation of hazardous ... with the ability to manage others Follow all Health & Safety/Job Safety Analysis (JSA's) procedures. Operate fork trucks and other heavy equipment when properly… more
- Merck & Co. (Rahway, NJ)
- …yield, robust and scalable cell culture processes.Responsible for process characterization and regulatory filing activities to ensure a smooth and clear path to ... knowledge of statistical methods (design of experiments, multivariate data analysis ) and tools (SIMCA, JMP, etc.).Understanding of cell culture bioreactor… more
- Merck & Co. (Rahway, NJ)
- …genetic characterization techniques (eg, Southern blotting, gene copy number analysis , etc.) Excellent communication and interpersonal skills to work effectively ... results within tight timeline Preferred Experience and Skills Experienced in regulatory filing and preparing relevant documentation.Familiar with regulatory … more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta- analysis (MBMA) and clinical trial simulations (CTS) into programs… 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
