- The Hartford (Hartford, CT)
- …the representatives will work within established procedures in adherence to statutory, regulatory and ethical requirements. Start Date: October 6, 2025Hours: ... Monday - Friday, core business hoursLocation: This role can have a Hybrid or Remote work schedule. Candidates who live near one of our office locations (Hartford, CT, Lake Mary, FL, San Antonio, TX, Naperville, IL or Scottsdale, IL) will have the expectation… more
- University of Miami (Miami, FL)
- …Manages the faculty credentialing process to ensure new faculty meet institutional and regulatory requirements before their start dates, as outlined in their ... offer letters. Data Analysis and Reporting + Collects, reviews, and analyzes complex and confidential data, preparing detailed reports, charts, and presentation materials for decision-making. Human Resources Liaison + Acts as the primary HR liaison, managing… more
- Stanford University (Stanford, CA)
- …include:** + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start -up through close-out. + ... case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. +… more
- Lilly (Boston, MA)
- …study conduct including study design, safety management plans, protocol writing, regulatory documents, CRO interactions, study start up, investigator ... GCP + Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and...(IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions + Author relevant protocol sections, and review… more
- Abbott (Alameda, CA)
- …(GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements. + Participate in study start up activities. ... and final reviews of study data in preparation of regulatory submissions. + May interact with RA/QA in responding...management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Proficient with Microsoft Suite The base… more
- Lilly (Pleasant Prairie, WI)
- …+ Preferred attributes but not required: + Solid understanding of basic requirements of regulatory agencies + Previous facility or area start up experience + ... Modes Effect Analysis (FMEA). + This role has direct interaction with Regulatory Agencies during site inspections. + Understand and influence the manufacturing… more
- Equitable (Charlotte, NC)
- …Monitoring Programs. + Assist with reviews of FinCen 314a and other screening regulatory required functions and processes start to finish, including coordination ... continually identifies new business risks and lessons learned from applicable regulatory enforcements. + Execute AML and Sanctions annual risk assessment program,… more
- Lilly (Pleasant Prairie, WI)
- …device assembly and or packaging operations + Solid understanding of basic requirements of regulatory agencies + Previous facility or area start up experience + ... Modes Effect Analysis (FMEA). + This role has direct interaction with Regulatory Agencies during site inspections. + Understand and influence the manufacturing… more
- Lilly (Indianapolis, IN)
- …+ Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. + Proven strong communication, ... collaboration with cross-functional partners including medical affairs, clinical operations, regulatory , statistics and data science to advance the oncology pipeline… more
- ThermoFisher Scientific (Wilmington, NC)
- …related meeting minutes. + May assist with start -up activities and support start -up team in Regulatory submissions. + Works in collaboration with teammates ... and reports to internal team members. + Reviews and tracks local regulatory documents. Maintains vendor trackers. + Analyzes and reconciles study metrics and… more