Associate Analyst, Clinical Contracts

Edwards Lifesciences • Irvine, CA

3d

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 or equivalent in related field with 1 year of previous related experience in contract negotiation/administration or equivalent work experience based on Edwards criteria.

Nice To Haves

• Experience in healthcare related contracts
• Good understanding of the MSA, SOW, Change Order and NDA templates and drafting to negotiate and redline contractual language
• 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. GCP) and documents and good understanding of medical device trials
• 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

Responsibilities

• Preparing initial contract file and drafts, redlines and negotiating basic contracts based on basic knowledge of financial, regulatory and clinical requirements.
• Developing processes, planning strategies and managing CLM system.
• Collaborating with key stakeholders, including Legal, Compliance and Finance to obtain or clarify data required for contracts.
• Interfacing with 3rd parties to obtain required data, and/or acquiring clarification to data in order to initiate and finalize contracts.
• Submitting proposed final draft and supporting documentation through enterprise management system for contract approval and securing appropriate signatures within specified signing authority.
• Generating reports (e.g., expiration, cycle status, terms).

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: Entry Level