Edwards Lifesciences Sr Analyst, Medical Affairs in Tokyo, Japan
Provide expertise on assigned Medical Affairs programs
Key Responsibilities: • Analyze and evaluate changes in laws and regulations relating to IIS and identify the impact on Edward and share recommendations internally • Analyze and evaluate emerging medical treatments and clinical outcomes for products related to Edwards, and recommend where Edwards should change current processes. • Review medical content in BU promotional materials, including educating marketing team on best approach to write medical related content • Participate in the review and assessment of new IIS (Investigator Initiated Study) proposals while insuring compliance with Medical Affairs processes. Assist with preparing presentations for ensuring an informed review process of proposals • Maintain the database for all IIS’s, track milestones accomplishments and insure associated payments. • Provide assessment to sites and investigators, determine challenges, and define mitigation plans. Provide regular updates to management and business unit partners on ongoing studies • Other Incidental Duties
Education and Experience: Bachelor's Degree in in related field, 5 years years experience of previous related experience Required and Experience in Clinical Affairs or Regulatory Affairs in Medical Device or Healthcare industry Required Master's Degree or equivalent in in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred
Additional Skills: • Project management skills • Proven expertise in both Microsoft Office Suite, including advanced Excel. • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives • Good English skill • Full knowledge of medical affairs within the organization while contributing to the development of new concepts, techniques, and standards • Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to Medical Affairs • Full knowledge of all medical affairs strategies • Strict attention to detail • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization • Ability to manage competing priorities in a fast paced environment • Represents leadership on sections of projects within a specific area interfacing with project managers and medical affairs team • Provides leadership to outsourcing partners on a task level • Adhere to all EHS rules and requirements 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.