- 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 Expertisejob 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
- 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 submissionjob 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 submission
- job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse thatjob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that
- 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. Reporjob 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. Repor
- job summary: 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 a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-valuejob summary: 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 a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value
- job summary: The Medical Editor, Value & Access, is responsible for reviewing, editing, and supporting documents developed by Value & Access including AMCP dossiers, compendia, and product monographs. This individual provides editorial expertise for multiple projects across therapeutic areas within established timelines, interfaces regularly with medical writers to ensure accurate and timely delivery of information and contributes to cross-functional meetjob summary: The Medical Editor, Value & Access, is responsible for reviewing, editing, and supporting documents developed by Value & Access including AMCP dossiers, compendia, and product monographs. This individual provides editorial expertise for multiple projects across therapeutic areas within established timelines, interfaces regularly with medical writers to ensure accurate and timely delivery of information and contributes to cross-functional meet
- job summary: A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! location: North Chicago, Illinois job type: Contract salary: &#xjob summary: A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! location: North Chicago, Illinois job type: Contract salary: &#x
- job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse thatjob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that
- job summary: Ensures accurate and consistent coding of medical data, including but not limited to, adverse event verbatim descriptions and medication data received from global clinical trials across all clinical areas including identification of prohibited medications and exclusionary medical history. Participates in Centralized Clinical Coding Group (CCCG) process improvement initiatives and serves as a subject matter expert and primary coding resource fjob summary: Ensures accurate and consistent coding of medical data, including but not limited to, adverse event verbatim descriptions and medication data received from global clinical trials across all clinical areas including identification of prohibited medications and exclusionary medical history. Participates in Centralized Clinical Coding Group (CCCG) process improvement initiatives and serves as a subject matter expert and primary coding resource f
- job summary: The Biologics Drug Product Development team develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. We are looking for a highly motivated person to support Developability and Fojob summary: The Biologics Drug Product Development team develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. We are looking for a highly motivated person to support Developability and Fo
- job summary: The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understajob summary: The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understa
