- 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
- J&J Family of Companies (Titusville, NJ)
- …serving on multifunctional teams delivering clinical trials in an R&D or Medical Affairs setting. Preferred: + Experience with Oncology research, notably ... will include Real-World Evidence, cell profiling, clinical phenotyping, computer vision/ medical imaging that leverage technologies such as statistical methodologies,… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development… more
- GE HealthCare (Waukesha, WI)
- …contact for cross-functional teams including hardware, software, clinical applications, and regulatory affairs ; Mentor junior engineers and contribute to ... the use of software tools for analysis and simulation. + Experience with regulatory standards and design controls for medical devices. + Excellent communication,… 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
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …of the plant, ensure proper representation of the plant in all legal, tax and any regulatory affairs as it concerns plant. Ensure that the proper image of the ... - Proficient + Working knowledge of FDA regulations & other medical device regulatory compliance requirements - Proficient + Decision making, and coaching skills… more
- University of Colorado (Aurora, CO)
- …prepares for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs , Primary CRC and other research team members **Intermediate ... Research Coordinator Data Focused** **Description** **University of Colorado Anschutz Medical Campus** **Department: Cancer Center - CCTO (GI Team)** **Working… more
- AbbVie (North Chicago, IL)
- …management for discovery research. + Collaborate with divisions such as government affairs , investor relations, legal, and regulatory teams to align ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...supporting R&D and enterprise goals. + Represent the corporate affairs function on the Executive Animal Committee and lead… more