Analyst, Clinical Vendor Contracts

Imagine how your ideas and expertise can change a patients 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 youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients 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. Its 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.
• Identifying opportunities for process improvement in collaboration with cross-functional teams; presenting and implementing process improvement plans to management and/or key stakeholders.

What youll need (Required):

• Bachelors 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 teamenvironment 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 $68000 to $96000 (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.