- Merck & Co. (Rahway, NJ)
- …and personnel decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start - up , qualification and/or validation is preferredFill/finish process ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- BioAgilytix (Durham, NC)
- …designing Azure Data Factory and API integrations, automating data-quality checks, and setting up clear governance so everyone knows who can see or change each ... dataset. You'll start as a "player-coach," doing the technical heavy lifting...that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for new instrumentsResponsible for working with groups to provide start - up , commissioning, and qualification/validation support of instrumentation and ... operations according to cGMP requirements. This individual will support organization build and ramp- up of clinical production and facility approval of a state of the… more
- Aequor (Hicksville, OH)
- …product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all batches. Major Accountabilities Provides direction/line ... assignments to packaging personnel. Starts up production lines at the beginning of the shift...at the beginning of the shift and at the start of batches to release lines. Monitors lines including… more
- Merck & Co. (Rahway, NJ)
- …work experience in manufacturing or development, in the areas of process start up , technology introduction, manufacturing and/or technical transferA minimum of ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …corrective actions and related issues Coordinate fabrication, procurement, installation, engineering start - up , and validation activities of new equipment and ... the design and implementation of manufacturing processes, instrumentation, and equipment start -ups from the laboratory through manufacturing scale. This role will be… more
- Eisai, Inc (Nutley, NJ)
- …Trial Assistant will support all phases of clinical study activities (feasibility, start - up , conduct and close-out) under the direction and supervision by ... Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- University of Miami (Miami, FL)
- … Analyst II reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start - up through study closure as ... well as the maintenance of regulatory documents to ensure compliance with applicable requirements and...the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for… more
- University of Pennsylvania (Philadelphia, PA)
- …of the initiation of Phase I-V clinical trials with a focus on required regulatory start - up approvals and associated site initiation documentation. Reporting ... Summary Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start - Up Specialist-CC to facilitate, with minimal… more
- Arkansas Children's (Little Rock, AR)
- …leadership and stakeholders. *Provide training and guidance to study teams on start - up procedures, regulatory requirements, and institutional workflows. ... Type:** Full time **Department:** CC033020 Clinical Research Operations **Summary:** The Study Start - Up Project Manager serves as the institutional lead and… more
- University of Washington (Seattle, WA)
- …some independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position will be ... responsible for expeditious coordination of the regulatory submissions in the study start - up phase to meet sponsor and institutional timelines, which is a… more
- Abbott (Abbott Park, IL)
- …Site Contracts Associate), as needed. Manage all aspects of study lifecycle to include site regulatory and quality: + Start Up + Nominate, approach, and ... + Identify, develop, and maintain sites capable of delivering start - up goals, study participation levels and required...up process and site initiation visits + Understand regulatory and legal requirements for study participation at a… more
- Abbott (Minneapolis, MN)
- …Site Contracts Associate), as needed. Manage all aspects of study lifecycle to include site regulatory and quality: + Start Up + Nominate, approach, and ... + Identify, develop, and maintain sites capable of delivering start - up goals, study participation levels and required...up process and site initiation visits + Understand regulatory and legal requirements for study participation at a… more
- Vitalief (New Brunswick, NJ)
- …(for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials); Regulatory work required for start - up documents; Processes related ... work for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials; Regulatory work for start - up document; Contract review and… more
- University of Pennsylvania (Philadelphia, PA)
- …platform. Responsibilities include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. ... include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. Interacting with study… more
- Mount Sinai Health System (New York, NY)
- …Staff regarding specific protocols. + Manage clinical trials portfolio and assure timely regulatory start - up of protocols. + Monitor accruals and identify ... study enrollment, establishing a database of patients, protocol treatment and follow- up care for patients participating in clinical trials. + Collaborates with… more
- Merck (Durham, NC)
- …project management concepts and techniques as they relate to laboratory testing start - up , regulatory requirements for new assay development/validation, ... goals + Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing + Capability to function effectively within… more
