Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best p...
Job Description: The Digital Lab Interactive Visual Aid (IVA) Specialist is part of the Digital Lab Veeva IVA team and will be responsible for creating and routing Veeva CLM (Closed Loop Marketing) aka IVA (interactive Visual Aide) content...
Responsibilities: Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the develop...
Responsibilities: Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones...
Responsibilities: Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for...
Job Description: The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is...
Responsibilities: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to ...
Responsibilities: Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data. Keeps abreast of industry trends in...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
Responsibilities: The scientist will conduct analytical experiments to support structural characterization and identification of biological macromolecules using liquid chromatography and mass spectrometry. The selected candidate will be ...
Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards an...
Job Description: We are seeking a highly motivated and collaborative Associate Scientist to join our Dermatology Immunology group within Discovery Research. This individual will support early- through late-stage discovery programs by suppo...
Responsibilities: Support clinical trial applications submitted via Clinical Trial Information System (CTIS), uploading documents, Qin documents uploaded to ensure accurate categorization. Track CTIS application details to compile metric...
Job description: This position provides support and drive for activities that support the overall long-range plan ensuring the department/functions continues to be competitive and meets all required cost, compliance and customer service ne...
Responsibilities: Technical expert that will independently investigate, identify, develop, and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. R...
Responsibilities: Independently identify, prioritize, and lead all CDM activities for assigned study. Represent CDM function at internal/external team calls. Communicate and able to provide CDM expertise for DM related activities. Resp...
Responsibilities: Support Digital Strategy Lead in the development of digital strategy and Client endpoint and provide input in the patient insight research, technologies evaluation, usability testing, vendor qualification, and validation...
Job Description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to deter...
Job Description: Quantitative, Translational & ADME Sciences Department has an open position for a Scientist III position in North Chicago, IL. The successful candidate will be responsible for non-regulated quantitative LC-MS/MS bioanalysi...
Responsibilities: Perform routine and advanced wet lab protocols in cellular and molecular biology. Maintain and culture human stem cells and their derivatives (maintenance, passaging, freezing/thawing). Support cell culture operations ...