The Clinical Counsel position joins the Edwards Legal team and will be an integral member of the group that is charged with the timely and thorough review, negotiation and management of Edwards Clinical templates and routine third party contracts including clinical trial agreements and informed consent forms supporting clinical research.
Reporting to the Vice-President, Associate General Counsel, the successful candidate will: (i) review and negotiate clinical trial related contracts for multiple clinical trials conducted worldwide; (ii) provide timely and appropriate escalation of issues to more senior attorneys within the group, when required; (iii) assist in the continuing development and revision of standard form agreements and implementation of processes and procedures for review and approval of clinical trial related agreements; (iv) train internal clients on contract forms and procedures; and provide guidance and support to various contracts specialists within Edwards.
A successful candidate will also be familiar with other standard operational agreements such as confidentiality, consulting, IT, facilities, manufacturing, commercial and marketing, advertising/agency, learning and development/staffing services, grant and sponsored research, advisory, research and development, general services agreements, as they relate to Clinical trials in a medical device company and be well-versed in basics of contract formation and interpretation.
Essential job functions include:
Drafting and negotiating routine clinical trial agreements and other contracts and documents supporting clinical research.
Interfacing with internal clients, attorneys as well as outside parties in connection with global clinical contracts matters.
Working in an integrated team environment within the legal group while also demonstrating the ability to work independently and escalate issues to attorneys appropriately.
Develop a deep understanding of and familiarity with: Edwards’ business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel to Edwards clients.
Identify training needs and assist in development and presentation of training and education regarding clinical trial requirements and developments globally.
Perform other duties and responsibilities as assigned.
Graduation from ABA accredited law school with top academic credentials.
Licensed and admitted to practice law in good standing in at least one U.S. state.
At least 1-4 years of medical device, pharmaceutical or biotech experience in either private practice, in-house counsel and/or government (FDA).
Demonstrated experience with and knowledge of transactions and contracts.
Willingness and ability to work with and coordinate activities across a large number of individuals across various departments, not only at Edwards headquarters, but also throughout Edwards locations in Europe, Latin America and Asia.
In close cooperation with Senior Attorneys, appropriately triage a heavy workflow, setting appropriate priorities and delivering results efficiently.
Ability to provide legal advice and support to internal clients.
Ability to think creatively, identify solutions to challenging problems and effectively drive issues to closure.
Decision-making ability and experience. Ability to manage several high-priority projects simultaneously.
Problem solver—able to find practical solutions and provide practical guidance.
Accountable and hands-on, self-starter, results oriented.
Desire to understand products and business.
Ability to work independently and as a team.
Experience with or knowledge of Clinical Trial/Medical Device contract issues that overlap with FDA/Medical Device regulation is desirable, but not required.
Experience with reviewing clinical trial agreements, and clinical trial informed consent forms is desired, but not required.
Thorough understanding of the contract process including contract evaluation, negotiation, approval, tracking and close-out is desired, but not required.
Experience with or knowledge of data privacy contract issues foreign and domestic is desirable, but not required.
Experience with or knowledge of intellectual property contract issues is desired, but not required.
The ideal candidate will be flexible and willing to learn new procedures and skill sets.
Must have excellent organizational skills and the ability to perform in a fast-paced, deadline-driven environment.
Ability to multi-task and handle multiple contract negotiations simultaneously.
Excellent oral and written communication skills with the ability to gain the trust of and form solid relationships with various business clients and Legal Department colleagues.
Internal Number: 017362
About Edwards Lifesciences LLC
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.