Edwards Lifesciences Senior Manager, Clinical Trials Contracts (HIPAA, Sunshine Act) in Irvine, California
Edwards Lifesciences is searching for a Contracts and Transactions Senior Manager to support our $800+ million Global Surgical Structural Heart (Surgical) business unit. This position is an integral part of the business unit team in Irvine, responsible for in ensuring that contracts are developed, negotiated, monitored, and updated in accordance with Edward’s policies and appropriate regulations and that payments due under these contracts are processed in an accurate and timely manner. This role will partner closely with customers, vendors, consultants, and a variety of internal shared service organizations, including Clinical Study teams, Compliance, Legal, Indirect Sourcing, and Finance & Accounting groups. A successful candidate will have prior contracting experience in a clinical or medical device setting, experience managing a team, and the demonstrated ability to build strong and trusting cross-functional relationships.
Translate business plans into appropriate contract terms and conditions in collaboration with business partners and the Legal and Compliance teams.
Read and negotiate contracts to identify and mitigate risk. Create and implement corrective action plans to limit exposure.
Ensure contracts are maintained and updated in appropriate Edwards systems (e.g., Electronic Contracts Lifecycle Management System) and establish procedures to ensure that contract renewals are in place prior to expiration.
Monitor and report on key performance measures specified in the contracts and ensure compliance with stated terms.
Assess the need for contract and budget amendments and provide guidance to key stakeholders, make recommendations, and/or negotiate changes to terms and conditions.
Identify opportunities to streamline and improve existing processes to increase efficiency and effectiveness, including the accurate and timely processing of payments.
Drive value-added initiatives related to contracts and transactions management by collaborating with Edwards functions (e.g., Compliance, Legal, Indirect Sourcing, Finance & Accounting), as well as Surgical business stakeholders.
Partner with Surgical business stakeholders to identify needs and ensure proper documentation (e.g., MSAs, NDAs, SOWs and approved purchase orders) is in place before work is commenced.
Manage and develop a team of contract specialists to create a center of excellence for contract and payment matters within Surgical. Develop and implement plans to ensure appropriate cross-training and subject matter expertise as it relates to contract matters and associated company policies, procedures, and processes.
A minimum of ten years of experience working with contracts
A minimum of two years’ experience managing teams of 3 or more individuals
Knowledge of GAAP
Prior experience as a paralegal
Experience with of medical terminology and healthcare compliance and privacy regulations (e.g., HIPAA and Sunshine Act)
A Master's or JD degree
Ability to manage confidential information with discretion.
Proactive, self-motivated, and results oriented, with an aptitude for problem solving and strong process improvement mindset.
Proven ability to prioritize and meet tight deadlines in an environment with competing priorities. Detail-oriented, flexible, with a high degree of urgency, accuracy, and efficiency.
Ability and willingness to balance “hand-on” execution with team development and delegation.
Excellent written and verbal communication skills, including negotiating and relationship management skills with ability to drive achievement of objectives.
Ability to interact professionally with all organization levels and proactively escalate issues to appropriate levels of management in the organization.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.