Principal Regulatory Affairs Specialist

This is an opportunity to join a global life sciences company in their medical devices division with complex devices and regulatory pathways. Working on predominantly PMA supplements and new 510k submissions, you'll have the chance to develop project management skills within the role.This is an FTE role that is 80% remote, but requires someone within driving...

Join a prominent global life sciences organization specializing in medical devices, where you will engage with intricate devices and navigate complex regulatory frameworks. This role primarily focuses on managing PMA supplements and new 510(k) submissions, offering you the opportunity to enhance your project management capabilities.This full-time position...

Position Overview:The Lead Manager for Global Regulatory Affairs CMC will play a pivotal role in overseeing regulatory CMC initiatives across various projects within our portfolio, particularly focusing on Oncology and Rare Diseases.Key Responsibilities:- Develop and implement CMC regulatory strategies for submissions, including IND/CTA/BLA/MAA, while...

Join a prominent global life sciences organization within their medical devices sector, focusing on intricate devices and regulatory pathways. This role offers the opportunity to enhance your project management capabilities while primarily handling PMA supplements and new 510(k) submissions.This position is a full-time role that allows for 80% remote work,...

Job SummaryThe Regulatory Toxicology Consultant will play a crucial role in supporting product discovery and development at Corbus Pharmaceuticals. This individual will work closely with internal cross-functional teams, external experts, and regulators to influence regulatory strategy, particularly with safety pharmacology and toxicology.Key...

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set,...

The Role:The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness...

The Role:The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness...

Overview:Moderna is seeking an experienced Principal Scientist to join our Bioanalytical and Molecular Assays team. This role involves supporting regulated non-clinical studies and clinical trials, specifically focusing on the bioanalytical assessment of cell therapies and the characterization of humoral and cellular immunogenicity of mRNA-LNP...

Overview:Moderna is seeking an experienced Principal Scientist to join our Bioanalytical and Molecular Assays team. This role involves supporting regulated non-clinical studies and clinical trials, specifically focusing on the bioanalytical assessment of cell therapies and the characterization of humoral and cellular immunogenicity of mRNA-LNP...

The RoleModerna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As a pivotal member of the CMC Statistics team, you will provide strategic statistical guidance and leadership to project teams.Working collaboratively with cross-functional teams, you...

Job SummaryWe are seeking a highly skilled Payer Enrollment Specialist to join our team at ICONMA. As a key member of our organization, you will be responsible for ensuring the timely and accurate enrollment of healthcare providers with payers.Key ResponsibilitiesCredentialing and Enrollment: Verify and validate provider credentials, including licenses,...

Job SummaryWe are seeking an Environmental Compliance Specialist to join our team at Triumvirate Environmental. As an Environmental Compliance Specialist, you will play a critical role in supporting our clients on-site by managing their hazardous waste programs and projects, utilizing state and federal regulations.Key ResponsibilitiesDevelop and Maintain...

Job title: Credentialing SpecialistLocation: Norwood, OHShift: M-F 8AM-4:40PM Hours: 32-40 hours per weekRequired: 5 years experience in Medical Staff Credentialing and privileging required only. Strong excel experience.Duration: 13 weeksJob Responsibilities:-Coordinate the credentialing activities of the Medical Staff and Allied Health Staff, in accordance...

Job title: Credentialing SpecialistLocation: Norwood, OHShift: M-F 8AM-4:40PM Hours: 32-40 hours per weekRequired: 5 years experience in Medical Staff Credentialing and privileging required only. Strong excel experience.Duration: 13 weeksJob Responsibilities:-Coordinate the credentialing activities of the Medical Staff and Allied Health Staff, in accordance...

The Role:Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the team to perform hands on LC-MS based clinical bioanalysis under GLP/GcLP compliance. A successful incumbent will provide scientific and operational oversight of pharmacokinetic (PK), lipids, protein, and routine biomarker bioanalyses for Moderna mRNA based...

The Role:Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the team to perform hands on LC-MS based clinical bioanalysis under GLP/GcLP compliance. A successful incumbent will provide scientific and operational oversight of pharmacokinetic (PK), lipids, protein, and routine biomarker bioanalyses for Moderna mRNA based...

Job DescriptionPosition Overview:We are seeking a dedicated and experienced Technical Manager with a strong background in chemistry or materials science to join our dynamic team.Key Responsibilities:The Technical Manager will be the pivotal North American liaison for Go To Market strategies and product launches, as well as the principal client contact for...

Job DescriptionJob DescriptionJob Title: Credentialing SpecialistJob Location: Norwood, OH (Onsite)Job Duration: 3months (Possibilities of Extension)Schedule: Mon to Fri 8AM 4:40PM HoursPay Range: $27 - $30/hr. on w2Job Summary:Responsible for coordination and preparation of medical staff functions; prepares for committee meetings, taking minutes, processes...

Position Title: Quality Assurance SpecialistLocation: Norwood, MADuration: 6 MonthsRole Overview:The Quality Assurance Specialist will focus on conducting rigorous testing in the realms of molecular biology and cell culture. A minimum of 3 years of experience in a GMP environment is essential.Key Responsibilities:Conduct QC molecular biology and bioassay...