- City of Jacksonville (Jacksonville, FL)
- …in dealing with others concerning permitting violations, compliance, and regulatory assistance including skills of persuasiveness, assertiveness, and sensitivity to ... military discharge papers, or equivalent certification from the Department of Veterans Affairs listing military status, dates of service and character of discharge.… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion...for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination… more
- Chiesi (Cary, NC)
- …the Associate Director will have the opportunity to do this work in a vibrant medical affairs research environment, with a strong innovative culture, and a cross ... report creation + Driving interpretation of analysis in collaboration with medical affairs leaders, scientists and internal stakeholders; communicating analysis… more
- City of Jacksonville (Jacksonville, FL)
- …and plans. + Issues building code citations and presents cases before regulatory agencies. + Investigates reported code violations and secures evidence in cases ... military discharge papers, or equivalent certification from the Department of Veterans Affairs listing military status, dates of service and character of discharge.… more
- City of Jacksonville (Jacksonville, FL)
- …records and reports. + Ability to read and understand technical manuals and regulatory requirements. + Ability to operate a computer to input and retrieve data. ... military discharge papers, or equivalent certification from the Department of Veterans Affairs listing military status, dates of service and character of discharge.… more
- HRPivot (Tucson, AZ)
- …of GLP animal studies, preclinical testing, and clinical studies. + Partner with Regulatory Affairs and Clinical teams to support FDA PMA submissions and ... proven R&D leader to drive the development of a highly advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval. The… more
- Penn Medicine (Philadelphia, PA)
- …RCAs, huddles and debriefs. * Partner with risk managers, patient safety officers, regulatory affairs , and senior leadership to advance key patient safety ... the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and...priorities and ensure with compliance with regulatory agencies. * Analyze data (ie, Safety Net reports,… more
- Ascendis Pharma (Palo Alto, CA)
- …Safety. + Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs , Commercial Organizations and PV staff as applicable. + ... mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, ... and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and...AND SKILLS:** + BSc in a scientific or allied health/ medical field (or equivalent degree). + Minimum of 7… more
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... This role is also responsible for the independent execution of regulatory -related decisions/strategies and coordinates work with study managers and other relevant… more