Edwards Lifesciences Analyst, Clinical Contracts - TMTT in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The Analyst Clinical Contracts will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.
• Initiate, draft, redline, and negotiate 3rd party moderately complex contracts based on substantial knowledge of financial, regulatory and clinical requirements
• Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions
• Collaborate with key stakeholders to provide guidance on functional contract terms and scope of services to secure appropriate approvals and mitigate risk exposure to the company
• Assist stakeholders and clinical vendors through the Supplier Quality Management System process
• Submit proposed final draft and supporting documentation through Edwards’ Contract Management system (ECLM) for contract approval and secure appropriate signatures within specified signing authority
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related field, 3 years of previous related experience in contract negotiation/administration Required. Experience in healthcare related contracts Required
• Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
• Good 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 guidelines relevant to contract negotiation and administration
• Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
• Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
• Advanced proficiency in Microsoft Office Suite, including Excel, and Word
• Good written and verbal communications skills
• Advanced problem-solving skills
• 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 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 is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.