- Merck & Co. (Rahway, NJ)
- …Documentation Practices (GDP) is required, as the successful candidate will be a reviewer and approver.- Regular feedback and coaching is a part of this position ... year.Learns equipment well enough to become a trainerDevelops daily plan and assignmentsFacility alarm first responder and early troubleshootingCoordinates with… more
- Merck & Co. (Durham, NC)
- …in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including assessing product impact for events, providing ... Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and ReportsOur Company… more
- Merck & Co. (Rahway, NJ)
- …statistical analysis to support biological and vaccine clinical assays.Author and review detailed statistical reports suitable for submission to health regulatory ... regulatory agencies.--Engage in AI/ML and statistical methodology research.Author and review detailed statistical reports, as well as respond to...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (Rahway, NJ)
- …sciences, Pharmaceutical sciences or relevant field with minimum of 12 years of industrial experienceRequired:Advanced knowledge in pharmacokinetics and ... other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Must be...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (Rahway, NJ)
- …and speed of our company's pipeline.This person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical ... engineers by coaching and developing for success through feedback and development guidance. Review and approve GxP documentation including but not limited to batch… more
- Merck & Co. (North Wales, PA)
- …reviewers to ensure it meets regulatory requirements while leading the summary through review and final approval - Collaborating with clinical teams , request ing ... and non-promotional - R esponding to clinical and legal review comments on PLS; amending the summaries as required...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (Rahway, NJ)
- …Risk Management leads to determine the data relationships and mapping.Lead data review meetings with content owners and Quality.Create and manage data linkages and ... from concept, launch and post market. -Support second person review with source data for regulatory filing.Support Design Transfer...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (South San Francisco, CA)
- …mentor a team of scientists in the research of immuno-metabolic disorders. Review and seek out potential external research collaborations and licensing opportunities ... to communicate effectively with and relate to a broad range of stakeholders, including senior leaders, peers, direct reports,...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (North Wales, PA)
- …Programming, Data Management, and our Company's Research Laboratories Scientists in long- range project planning, providing guidance to others in the statistical ... sound and meet worldwide regulatory and marketing needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and… more
- Merck & Co. (Rahway, NJ)
- …policies.Responsible for managing all external requests for clinical data.- Periodic review of metrics and identification of process improvement needsResponsible for ... global disclosure requirements, data access and all voluntary company policies. Review and approve local country disclosure SOP's to ensure...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (Durham, NC)
- …of the company, processes and clients and/or customers Solves a range of straightforward problems Analyzes possible solutions using standard procedures -Receives ... or learning events, as guided or approved by Quality management Author, review , and approve SOPs Participate in Kaizen events Direct support of regulatory… more
- Merck & Co. (Rahway, NJ)
- …Primary Activities include, but are not limited to: Supporting the preparation, review , and approval of documentation related to validation and quality operation of ... solutions. As part of this Quality Unit (QU) role, review and approve ERP changes. Work in dynamic environment...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (North Wales, PA)
- …architectural design patterns.Define and enforce development standards, best practices and review processes to ensure consistency of delivery quality and reusability ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (Rahway, NJ)
- …Guidelines. You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (North Wales, PA)
- …scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (Rahway, NJ)
- …tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to recruit, select, ... other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to...policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to… more
- Merck & Co. (Rahway, NJ)
- …customer resources, and lead approval of resources through the Promotional Review Team (PRT) process.Engage effectively with regions and marketsProvide leadership, ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (Durham, NC)
- …and finished product). The selected candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide ... of laboratory samples based on internal metrics and production needs.Author/ review technical documents, standard operating procedures, change controls, and… more
- Merck & Co. (North Wales, PA)
- …PlatformCollaborating with multiple teams including Global Marketing/US Marketing, Promotion Review Team (PRT), Global Market Research, Global Marketing Operations, ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (Rahway, NJ)
- …the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, and continuous ... policy are required to have a minimum of twelve ( 12 ) months of service in current position prior to...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
