In this role, you will be responsible for reviewing, revising, drafting, negotiating and advising on sophisticated and complex contracts, such as collaboration and partnering agreements, development agreements, key supply and services agreements, technology agreements, and co-marketing agreements.
The Senior Counsel will be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, and quality.
In this role, you will act as legal contact and compliance team escalation point for compliance issues, coordinate performance of compliance responsibilities with business units and provide necessary compliance training programs.
In this role, you will be developing an in-depth knowledge of, following, improving, updating and implementing investigation policies, processes, and procedures as well as in-house training and education.
In this role, the selected candidate will develop and enhance contract templates and guidelines; ensures contract language meets legal requirements and is designed to mitigate risk/liability to the company.