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 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.
