Analyst, Clinical Vendor Contracts

Edwards Lifesciences • Irvine, CA

1d

About The Position

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. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelor’s Degree in related field with 3 years of previous related experience in contract negotiation/administration and financial tracking/analysis against contracts or equivalent work experience based on Edwards criteria.
• Experience in healthcare related contracts

Nice To Haves

• Contract or paralegal certification
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, Excel, and SharePoint
• Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to contract negotiation and administration
• Moderate understanding of the MSA, SOW, Change Order and NDA templates and drafting to negotiate and redline contractual language
• Moderate understanding of Medical Device Trials, GCP, and compliance requirements
• Collaborate with the Study Team and Clinical Project Manager to strategize on site prioritization and enable fast site activation
• Partner with the Study Team to be able to plan accordingly on timeline of the negotiation process as well as plan for the final execution date
• Work with the Legal Partner to address terms and conditions that are outside internal approvals, seeking the guidance for an appropriate fallback clause on contracts
• Analyze need for contract amendments due to major protocol changes aligning with internal work instructions and practices
• Identify opportunities for process improvement independently or in collaboration with cross-functional teams
• Strong written and verbal communication skills and interpersonal relationship skills
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment

Responsibilities

• Initiating, drafting, redlining, and negotiating moderately complex clinical-related contracts (Master Service Agreements, Statements of Work, Service Provider Agreements, Non-Disclosure Agreements, Amendments, Change Orders) based on substantial knowledge policy and regulations governing Clinical Trials and Edwards Policy.
• Providing input on functional contract terms, budgets, and scope of services to secure appropriate approvals in collaboration with key stakeholders (e.g., Clinical Affairs, Legal Compliance, Finance.
• Identifying risks (e.g., vendor rates and pricing, fair market value, legal issues, conflict of interest) and actively engaging with management to provide recommendations for mitigation.
• Analyzing need for contract amendments or change orders and making recommendations, and/or negotiating changes, to scope, and terms and conditions.
• Submitting proposed final draft and supporting documentation through enterprise contract management system for contract approvals and securing appropriate signatures within specified signing authority.
• Identifying opportunities for process improvement in collaboration with cross-functional teams; presenting and implementing process improvement plans to management and/or key stakeholders.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees