job summary: Job Summary In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO R
job summary: Job Summary In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO R
job summary: Job Summary In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO R
job summary: Job Summary In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO R
job summary: Immediate opportunity for an experienced, Specialist Product Quality, to manage change control, deviations, and compliance records for biologics and synthetic chemical manufacturing. The Specialist Product Quality will collaborate cross-functionally with Supply Chain, Manufacturing, Quality Control, Regulatory, and other teams to ensure quality and compliance. Key Responsibilities include: Own and review change control, deviation records, a
job summary: Immediate opportunity for an experienced, Specialist Product Quality, to manage change control, deviations, and compliance records for biologics and synthetic chemical manufacturing. The Specialist Product Quality will collaborate cross-functionally with Supply Chain, Manufacturing, Quality Control, Regulatory, and other teams to ensure quality and compliance. Key Responsibilities include: Own and review change control, deviation records, a
job summary: This is a high level contract role, requiring Direct Global Regulatory Labeling Operations Project Management experience in the Pharma/Biotech industry, as deep knowledge of pharmaceutical labeling regulations, compliance, and processes are critical for this role. The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or i
job summary: This is a high level contract role, requiring Direct Global Regulatory Labeling Operations Project Management experience in the Pharma/Biotech industry, as deep knowledge of pharmaceutical labeling regulations, compliance, and processes are critical for this role. The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or i
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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowled
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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowled
job summary: We are seeking an experienced Regulatory Writer with a strong background in writing protocols, clinical study reports (CSRs), briefing books, informed consent forms (ICFs), and CTD Module 2 documents. This expertise is critical to the role. The successful candidate will play a key role in preparing high-quality regulatory documentation to support clinical and regulatory submissions, ensuring compliance with global regulatory requirements. Thi
job summary: We are seeking an experienced Regulatory Writer with a strong background in writing protocols, clinical study reports (CSRs), briefing books, informed consent forms (ICFs), and CTD Module 2 documents. This expertise is critical to the role. The successful candidate will play a key role in preparing high-quality regulatory documentation to support clinical and regulatory submissions, ensuring compliance with global regulatory requirements. Thi
job summary: We are seeking an experienced medical writing leader in medical communications to join an award-winning in-house agency at a major pharmaceutical company. This remote position offers the opportunity to work with a small but growing team in a long-term, salaried contract role. location: Telecommute job type: Outsourcing Project salary: $87 - 94 per hour work hours: 9 to 5 education: Doctorate responsibilities: Lead a team o
job summary: We are seeking an experienced medical writing leader in medical communications to join an award-winning in-house agency at a major pharmaceutical company. This remote position offers the opportunity to work with a small but growing team in a long-term, salaried contract role. location: Telecommute job type: Outsourcing Project salary: $87 - 94 per hour work hours: 9 to 5 education: Doctorate responsibilities: Lead a team o
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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowle
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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowle
job summary: As the world's 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. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare
job summary: As the world's 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. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare
job summary: Project Manager - Clinical Trial Process Optimization Exciting opportunity to drive innovation in clinical trial processes! 4 Openings: (3) Traditional PMs (1) Change Management PM Salaried Contract - 12 Months w/Full Benefits | Remote Join a high-impact team within a large pharmaceutical company, supporting continuous improvement and change management initiatives across the end-to-end clinical trial process. This role offers visibility and
job summary: Project Manager - Clinical Trial Process Optimization Exciting opportunity to drive innovation in clinical trial processes! 4 Openings: (3) Traditional PMs (1) Change Management PM Salaried Contract - 12 Months w/Full Benefits | Remote Join a high-impact team within a large pharmaceutical company, supporting continuous improvement and change management initiatives across the end-to-end clinical trial process. This role offers visibility and
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 that
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 that
job summary: Real-World Evidence & Biostatistics ~ Exclusive Summer Internship Opportunity We're looking for a highly motivated Master's or PhD student to join our Real-World Evidence (RWE) and Biostatistics research team for a Summer Internship. This role will focus on the application of Double Machine Learning in Causal Inference, providing exposure to real-world healthcare data and advanced statistical modeling techniques. The intern will work with cr
job summary: Real-World Evidence & Biostatistics ~ Exclusive Summer Internship Opportunity We're looking for a highly motivated Master's or PhD student to join our Real-World Evidence (RWE) and Biostatistics research team for a Summer Internship. This role will focus on the application of Double Machine Learning in Causal Inference, providing exposure to real-world healthcare data and advanced statistical modeling techniques. The intern will work with cr
job summary: Global Regulatory Operations Publishing | Undergrad Intern ~ Summer 2024 Are you a detail-oriented student eager to gain hands-on experience in Regulatory Operations and global health authority submissions? This internship offers a unique opportunity to contribute to the preparation and delivery of high-quality, timely, and compliant regulatory submissions in a fast-paced, cross-functional environment. As a Global Regulatory Publishing Under
job summary: Global Regulatory Operations Publishing | Undergrad Intern ~ Summer 2024 Are you a detail-oriented student eager to gain hands-on experience in Regulatory Operations and global health authority submissions? This internship offers a unique opportunity to contribute to the preparation and delivery of high-quality, timely, and compliant regulatory submissions in a fast-paced, cross-functional environment. As a Global Regulatory Publishing Under
job summary: Regulatory Affairs Manager II | REMOTE ROLE | PST Hours We are seeking a Regulatory Affairs Manager II to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong back
job summary: Regulatory Affairs Manager II | REMOTE ROLE | PST Hours We are seeking a Regulatory Affairs Manager II to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong back
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 impact 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: $
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 impact 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: $
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
job summary: Job Description The Medical Writing Intern (MWI) assists with medical writing activities in support of the GCDO - Medical Writing & Transparency department. The MWI works closely with MW personnel to develop regulatory documents in support of company products. This individual will work to assigned timelines, communicate effectively to the responsible medical writer, and ensure their deliverables are completed according to appropriate quality
job summary: Job Description The Medical Writing Intern (MWI) assists with medical writing activities in support of the GCDO - Medical Writing & Transparency department. The MWI works closely with MW personnel to develop regulatory documents in support of company products. This individual will work to assigned timelines, communicate effectively to the responsible medical writer, and ensure their deliverables are completed according to appropriate quality
job summary: Sr. Pharmacovigilance (PV) Operations Manager | Remote | West Coast This critical role is responsible for managing and overseeing PV operations across clinical development programs, ensuring seamless collaboration with PV vendors. You will play a key role in preparing for the initiation of two global Phase 3 trials, ensuring all PV activities are in place. Your expertise in global trial management, study document review, and vendor oversight
job summary: Sr. Pharmacovigilance (PV) Operations Manager | Remote | West Coast This critical role is responsible for managing and overseeing PV operations across clinical development programs, ensuring seamless collaboration with PV vendors. You will play a key role in preparing for the initiation of two global Phase 3 trials, ensuring all PV activities are in place. Your expertise in global trial management, study document review, and vendor oversight
job summary: We are seeking a Regulatory Submission Manager to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong background in regulatory submissions and document review, as
job summary: We are seeking a Regulatory Submission Manager to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong background in regulatory submissions and document review, as
job summary: Our client is seeking a Senior or Principal Statistician to support Synthetic Control Arm (SCA) projects in late-phase oncology trials, with a primary focus on SAS, CDISC, and ADaM. This is a fully remote, 6-month contract (potential to extend). location: New York, New York job type: Contract salary: $110 - 120 per hour work hours: 9 to 5 education: Doctorate responsibilities: Primarily support late-phase oncology trials (
job summary: Our client is seeking a Senior or Principal Statistician to support Synthetic Control Arm (SCA) projects in late-phase oncology trials, with a primary focus on SAS, CDISC, and ADaM. This is a fully remote, 6-month contract (potential to extend). location: New York, New York job type: Contract salary: $110 - 120 per hour work hours: 9 to 5 education: Doctorate responsibilities: Primarily support late-phase oncology trials (
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on onco
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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their bus
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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their bus
