Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

How you’ll make an impact:
• Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site
• Develop and write more complex medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures
• Evaluate packets (compiled by lower level employees) from source documents to ensure accuracy for event adjudication to CEC (Clinical Event Committee)
• Research clinical data used to develop and submit Global Regulatory reports
• Partner with team member(s) to develop and maintain global standards for providing training to enrolling sites and internal team
• Medical writing and literature review
• Review documentation and participate in internal and external audits to ensure all essential clinical safety files are compliant in accordance with Good Clinical Practice, Edwards internal SOPs and all other regulatory bodies
• Partner with team members to develop templates of CRF and Charters for Global Trials to ensure consistency and standardization
• Other incidental duties

What you'll need (Required):
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred
• Excellent written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Substantial understanding of medical terminology as it relates to clinical safety
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control