Experience in clinical operations, clinical monitoring, physician support, field clinical education, global regulatory compliance, or clinical trial management within the medical device industry.
AdventHealth: Non-profit healthcare system providing comprehensive hospital and medical services.
1+ YOEAssociate's degree in nursing, 1+ year of applicable experience, RN license, BLS, ACLS, and PALS required. Requires advanced Microsoft Office skills, regulatory knowledge, data analysis, and process improvement expertise.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, electronic health records systems
AdventHealth: Non-profit health care system providing hospital and medical services.
1+ YOEAssociate degree in nursing required; 1+ year applicable experience; RN, BLS/CPR, ACLS, and PALS required. Requires regulatory knowledge, audits, chart reviews, data analysis, process improvement, and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, electronic health records, healthcare IT systems
Smith Allergy & Asthma Specialists: Provides diagnostic and treatment services for allergies and asthma.
2+ YOE2+ years clinical research regulatory experience, Associate's degree, IRB submission and regulatory maintenance experience, REALTIME and Microsoft Office proficiency, knowledge of ICH-GCP and FDA regulations.
Chicago or Atlanta or Austin or Denver or Houston or Phoenix or Boston or Minneapolis or Charlotte or Dallas or United States
$85k-$95k/yrRemoteFull Time
LivaNovaNASDAQ: LIVN: Manufactures medical devices for cardiac and neurological therapies.
5+ YOESupport EU MDR and US regulatory submissions; develop CEP/CER; conduct literature reviews; liaison with regulatory authorities and internal teams.
Medical writing, Regulatory submissions, Literature databases
Keck Medicine of USC: Provides specialized medical care and research via university health system.
3+ YOE3+ years clinical research/regulatory experience, knowledge of FDA/ICH-GCP, eRegulatory and CTMS/EDC platforms, strong organization, training, and communication skills.
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), electronic Investigator Site File (eISF), eBinder, Florence eBinders, Complion, Google suite, Slack, Skype
University of Southern California: Private research university providing higher education and healthcare services.
2+ YOEBachelor's degree and minimum 2 years clinical research/regulatory experience; experience with IRB/FDA submissions, GCP/OHRP/FDA regulations, strong organization, problem-solving, and communication skills.
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches and develops medicines to treat major diseases globally.
2+ YOEBS in life sciences, medical writing experience (manager:2+ yrs; associate director:7+ yrs), ability to author complex clinical-regulatory documents, strategic communications and team leadership, knowledge of regulatory requirements.
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
2+ YOEBS in life sciences,2+ years medical writing experience in pharma/CRO (7+ yrs for Associate Director),knowledge of regulatory requirements,ability to lead authoring teams and author complex clinical-regulatory documents.
Temporary Clinical Research Regulatory Coordinator
Orange, California, United States
$38/hrHybridFull Time
University of California, Irvine: Public research university offering higher education and academic degrees.
3+ YOEBachelor's or equivalent, 3–5 years regulatory clinical research experience, knowledge of FDA/GCP/IRB, ability to manage multiple regulatory projects, strong organizational and communication skills.
Corewell Health: Healthcare system providing medical care and health insurance services.
2+ YOEBachelor's or equivalent, active Michigan RN license, 2 years related experience, clinical background, BLS/CPR implied; compliance or accreditation experience preferred.
Cooper University Health Care: Operates a leading academic health system in South Jersey.
3+ YOEBachelor's degree required (Master's preferred),3+ years clinical research experience, managing regulatory submissions and documentation, strong communication and coordination skills.
Clinical Research Regulatory Specialist - SMS-3831
Springfield, Illinois, United States
$44k-$48k/yrOnsiteFull Time
SIU Medicine: Provides medical education and clinical healthcare services.
Bachelor's degree required; support clinical research operations, regulatory submissions, IRB and FDA compliance, maintain regulatory files and databases, perform QA and patient data collection.
Microsoft Access, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, eREG
Pacira BioSciencesNASDAQ: PCRX: Develops non-opioid pain management and regenerative health products.
14+ YOEBachelor's degree in life science or related field, 14+ years in regulatory affairs, clinical regulatory strategy leadership, health authority interactions, submissions, cross-functional decision-making, and people or matrix leadership.
University of Alabama at Birmingham: Provides academic education, medical research, and clinical healthcare services.
5+ YOEBachelor's degree in a related field and five years of related experience; regulatory oversight and QA in clinical trials; certifications preferred.
Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, Florida, United States
HybridFull Time
Cardiovascular Associates of America: Operates a national network of cardiovascular medical practices.
2+ YOEAssociate degree required; 2+ years clinical research regulatory experience; IRB submissions, REALTIME eRegulatory experience preferred; strong knowledge of ICH-GCP and FDA regs; proficiency with electronic regulatory systems and Microsoft Office.
REALTIME CTMS, REALTIME eRegulatory, Microsoft Office
Mary Bird Perkins Cancer Center: Provides comprehensive cancer care and clinical research services.
Manage regulatory and data activities for clinical trials, maintain IRB and protocol documents, coordinate with investigators and sponsors; bachelor's or equivalent experience preferred.
Parexel: Provides clinical research and regulatory services for drug development.
15+ YOEMD or PhD required, 15+ years clinical development/regulatory experience, expert in clinical trial design and authoring clinical regulatory sections; prior regulatory agency experience preferred; international product experience and thought leadership expected.
Pacira BioSciencesNASDAQ: PCRX: Provides non-opioid pain management and regenerative health solutions.
Advanced regulatory affairs experience in U.S. pharma with demonstrated regulatory strategy, health authority interactions, leadership, project management, and strong written/verbal communication.