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job summary: Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with expertise in Regulatory Systems, eCTD submission management, and experience working with global IT and cross-functional teams to drive system implementation and Quality Control Process, Documentation & Testing. Key Focus Areas: Regulatory Systems Expertise | eCTD Submission | Management Global Collaboration with IT & Regulatory Stakeholders | Quality Control Processes Documentation & Testing REQUIRED: Regulatory Operations & Regulatory Systems & submission process experience Strong tool knowledge: Veeva, InSight, Docubridge, CARA, etc. Process documentation, SOPs, SOWs, workflow mapping, UAT testing Experience supporting system implementation and end-user training Solid understanding of HA regulations related to submissions and regulatory technologies   location: Chicago, Illinois job type: Contract salary: $60.00 - 64.12 per hour work hours: 9 to 5 education: No Degree Required   responsibilities: Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions.Oversee outsourced publishing deliverables to ensure successful execution of operational activities for assigned products.Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.Responsible for electronic submissions and documents meeting regulatory agency and company submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.Competent in the use of electronic document management and submissions publishing tools.  qualifications: REQUIRED 3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. *LI-AT1   skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

job summary: REGULATORY AFFAIRS MANAGER | 100% Remote (EST Coast based) We're supporting a high-impact Regulatory Submissions Delivery role focused on US and EU regions, with global scope. What we're looking for: 3-5 years of Submission Delivery Support experienceStrong knowledge of US & EU regulatory requirementsBackground in publishing and vendor management a big plusExperience with NDA/MAA filings and larger submissionsSkilled in lifecycle submissions, query management, and QC reviewDeep understanding of eCTD components, compliance standards, and document QCAble to coordinate with vendors and stakeholders for timely, accurate submission deliveryMust know what to look for in eCTD docs-US regulations experience is key   location: Chicago, Illinois job type: Contract salary: $60 - 65 per hour work hours: 9 to 5 education: No Degree Required   responsibilities: Performs eCTD submission management across Company's product portfolio to Health Authorities for global development and lifecycle management submissions.The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.Responsible for electronic submissions and documents meeting regulatory agency and Company submission standards and technical requirements.Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.Competent in the use of electronic document management and submissions publishing tools.  qualifications: 3-5 years of experience in regulatory operations providing submission delivery support for the US and Eurpoe.Experience overseeing publishing vendors preferred #LI-AT1   skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

job summary: Responsible for collection and testing of routine environmental monitoring samples within aseptic processing fill lines, Isolator fill line, compounding, sterility suite, and component preparation areas for aseptic lines (Building A) and clean rooms areas in new expansion Building B. Collect and test utility samples such as WFI, clean steam and compressed gases. Monitors environmental conditions in laboratory areas during test sessions. Reports testing results and documents in compliance with cGMP and GLP standards. Provides support to Scientist, Lead Scientist, and Supervisor. Prepares media, reagents, sanitizing solutions and equipment for use in testing. Shift: A shift: 5:45 AM - 6:15 PM Rotating schedule 2 days on 2 days off every other weekend (OT on a need basis)   location: Melrose Park, Illinois job type: Contract salary: $28.00 - 31.72 per hour work hours: 7 to 3 education: High School   responsibilities: Perform environmental monitoring in controlled areas for non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden and personnel monitoring.Maintain gowning certification and apply good aseptic technique and clean room behavior_Collect and process samples for water for Injection (WFI), clean steam and compressed gases according to established standard operating procedures.Perform bioburden, endotoxin, Total Organic Carbon (TOC), and conductivity testing for utility samples.Perform sub-culturing and Gram-staining of microorganisms.Perform growth promotion on incoming media to release for monitoring use in the facility. Maintain and review temperature records, lab cleaning records, and logbooks.Input results in Laboratory Information Management System (LIMS) database and track microbiological results. Must be able to understand and follow company's good documentation practices.Compile and submit environmental monitoring data for critical system release.Supports Scientist/ Lead Scientist/ Supervisor with testing and special projects. Carries out special projects independently as required and assigned by supervision.Aids with plant and laboratory equipment re-qualifications as directed.Promptly reports data discrepancies and out of limit conditions to supervision. Carries out documentation, and assist Scientist and Lead Scientist with investigation, incident reports and corrective actions as assigned. Assists in training new departmental personnel in standard operating procedures, training modules and checklists.Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.Maintains compliance with company policies, training requirements, cGMP's.Follow safety requirements, maintains good housekeeping of lab areas including 5S.  qualifications: Required: BS / BA Science degree ORAS / AA + 1-3 years lab / pharma experience ORSome college + 5+ years lab/pharma experience (testing, food, cosmetic, veterinary, hospital labs)1 year of GMP Pharma experience   skills: GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days.