- Merck & Co. (Rahway, NJ)
- …Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: Monitor user ... Experience and Skills:Candidate must be familiar with IT system and business process support , preferably in the Regulatory or Labeling Management space with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for quality management (eg, completing ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Merck & Co. (Rahway, NJ)
- …regulatory compliance, aligning with the company's divisional and local site procedures. Support regulatory inspections and maintain proficiency in ISO 13485, ... programs decisions through the development team and governance forumsAuthor and complete regulatory filing sections, and support response to questions and… more
- Insmed Incorporated (San Diego, CA)
- …provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national ... and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability… more
- Merck & Co. (Durham, NC)
- …readiness and technology transfer focusing on either upstream, downstream, and/or culture media/ support systems . Off-shift and weekend coverage will be required ... deepening process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology, analytics, and ... reporting initiatives across the NovoCare® Patient Affordability and Access Support Platform. Oversight, maintenance, and ongoing enhancements related to the Patient… more
- BioAgilytix (Durham, NC)
- …rather than days. Over time, the same foundation you build will support dashboards, predictive analytics, and other data-driven tools that boost lab productivity ... and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with… more
- Insmed Incorporated (San Diego, CA)
- …development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... team to take care of the operational aspects of analytical testing to support process development to enable rapid development of upstream, downstream and formulation… more
- Merck & Co. (Rahway, NJ)
- …is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing ... support . BDSC supports stage 1 & 2 process validation...process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of… more
- Twist BioScience (South San Francisco, CA)
- …influence stakeholders at all levels and effectively communicate complex technical and regulatory concepts.Ability to travel as required to support global ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and ... will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile… more
- Aequor (Athens, GA)
- …management systems and migration of records from legacy systems . Electronic Document Management (controlled documents, regulatory submission documents): ... support site users in workflow configuration. Provide routine user support . Electronic Document Management (controlled documents, regulatory submission… more
- Merck & Co. (Durham, NC)
- …electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems ).Required Experience and Skills:Familiarity of regulatory requirements ... Lead Tech, Engineering is a member of the Engineering team providing technical support within a capital project start-up in Durham, North Carolina. The new facility… more
- Merck & Co. (Durham, NC)
- …electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems ).Required Experience and Skills:Familiarity of regulatory requirements ... Tech, Engineering is a member of the Engineering team providing technical support to the manufacturing site.- The site includes clean utilities, facilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Skills:cGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, ... in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (North Wales, PA)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor ... instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, OSHA… more
- Eisai, Inc (Raleigh, NC)
- …applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail and ability to ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- Aequor (Thousand Oaks, CA)
- …Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more ... of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Preferred Qualifications ? Ability to adhere… more
