- Mount Sinai Health System (New York, NY)
- …or health care policy. + A minimum of 5 years of research experience in Regulatory Affairs , Clinical Affairs or Quality Assurance with knowledge of Phase ... for IRB annual renewal review and approval. + Collaborates with the Principal Investigator (PI) in completion of required regulatory documents including,… more
- Kelly Services (Philadelphia, PA)
- …regulatory documentation to support Management of Change projects. Situated in Global Regulatory Affairs , the specialist will prepare, review and finalize all ... and consistency across multiple systems. This position offers the opportunity for a regulatory affairs professional to further develop a career in the regulation… more
- Mount Sinai Health System (New York, NY)
- …science or legal/ regulatory studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...for IRB review and approval. + Collaborates with the Principal Investigator (PI) in completion of application documents including… more
- Rush University Medical Center (Chicago, IL)
- …(SOPs) are implemented and documented in accordance with study sponsor, Principal Investigator, and regulatory agency specifications. * May collaborate ... on the circumstances of each case. **Summary:** This positions provides regulatory support for multiple clinical research studies, which may involve multi-centered… more
- Georgetown Univerisity (Washington, DC)
- …life science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + FDA, ICH-GCP) Familiarity with regulatory ... dedication to making a difference in the world. Requirements Job Overview The Regulatory Coordinator plays a critical role in ensuring regulatory compliance and… more
- Stanford University (Stanford, CA)
- …including project management in a dynamic research setting. + Strong knowledge of regulatory affairs , including FDA regulations, IRB review and approval process, ... scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and… more
- Wolters Kluwer (Chicago, IL)
- …Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic ... The ** Principal SaMD Technical Program Manager** plays a pivotal...**Cross-Functional Collaboration:** Act as a liaison between engineering, product, regulatory affairs , clinical, and QA teams to… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... vetting with all internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations to… more
- Bristol Myers Squibb (Madison, NJ)
- …of key functions (eg, early development, TM, clinical pharmacology, toxicology, regulatory , HEOR, market access, medical affairs ), applying foresight, scientific ... and will supervise and have accountability for the clinical components of regulatory filings. * Will contribute to overall Therapeutic Area disease strategy while… more
- Danaher Corporation (New York, NY)
- …activities, working closely with following functions: marketing, sales, research & development, clinical affairs , and regulatory affairs . In this role, you ... Manager who will be responsible for supporting our global Medical and Scientific Affairs team. This position serves as the principal interface between the… more