Edwards Lifesciences Associate Analyst - Clinical Contracts - Transcatheter Mitral and Tricuspid Therapy 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 Associate Analyst Clinical Contracts will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.
• Prepare initial contract file and drafts, redlines and negotiate basic contracts based on basic knowledge of financial, regulatory and clinical requirements
• Develop processes, plan strategies and manage CLM system
• Collect required documentation for Indirect Sourcing non-HCP (health care providers) contract submission through GTA
• Collaborate with key stakeholders, including Legal, Compliance and Finance to obtain or clarify data required for contracts
• Interface with 3rd parties to obtain required data, and/or acquire clarification to data in order to initiate and finalize contracts
• Submit proposed final draft and supporting documentation through Legal Department’s RFA system for contract approval and secure appropriate signatures within specified signing authority
• Generate reports (e.g., expiration, cycle status, terms)
• Other incidental duties
Education and Experience:
Bachelor's Degree or equivalent, Minimum of 1 year experience within contract negotiation/administration Required
• Good computer skills 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
• Good knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
• Basic knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
• Basic understanding of regulatory requirements (e.g., CFR, GCP) and documents
• Good computer skills in Microsoft Office Suite, including Excel, and Word
• Good written and verbal communications skills
• Good 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 immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally
• 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.