- AbbVie (Washington, DC)
- …R&D organization and not on FDA promotional considerations. + Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and ... in FDA regulations and guidance around innovator drug development, including on clinical trial design and study requirements, regulatory exclusivities, orphan… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... is true to the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Vanderbilt University Medical Center (Nashville, TN)
- …care, education, and research. **Organization:** Quality Admin **Job Summary:** The Associate Director supervises, coordinates and monitors the work activity of a ... The VUMC Quality Administration Laboratory Department is in need of a ** Associate Director** to join the team! **Department Summary:** Our new 110,000-square-foot… more
- AbbVie (North Chicago, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other ... to augment expertise in the therapeutic area. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring ... and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality for complex clinical deviations and Serious Breaches. + Review… more
- Sumitomo Pharma (Lansing, MI)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Clinical Trial Associate for Study Start-up** **.** The Clinical ... the study team(s). + The SSU CTA supports the collaboration with CPMs, CRAs, Clinical Business Operations, Medical Affairs , study sites, study team and CRO, if… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. ... more than 160 countries. **The Opportunity:** The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This… more
- J&J Family of Companies (Irvine, CA)
- …at https://www.jnj.com/medtech We are searching for the best talent for an ** Associate Director, Project Management** ( ** Clinical Research)** to support our ... Build and maintain strong relationships with internal and external stakeholders, including clinical . Medical, Regulatory and R&D teams. + Ensure consistency,… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more