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.
How you will make an impact:
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.
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Identifying opportunities for process improvement in collaboration with cross-functional teams; presenting and implementing process improvement plans to management and/or key stakeholders.
What you’ll need (Required):
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
What else we look for (Preferred):
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
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $68,000 to $96,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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