General Counsel

• Counsel clients on a wide range of regulatory compliance issues with a focus on current GxP practices, quality processes, and contracting related to the research, development, manufacture, and distribution of innovative, biosimilar, and generic pharmaceuticals, worldwide.
• Work collaboratively with cross-functional teams to develop and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans.
• Draft, review, and negotiate a wide range of R&D-related agreements, including: Clinical trial agreements, Consultancy and service agreements, Research collaborations and MTAs, Investigator-initiated study agreements, Licensing agreements, Academic collaboration and research consortium agreements.
• Participate in internal meetings to review quality metrics, participate in site or project governance committees, and facilitate internal audits.
• Partner with Compliance to provide legal support for internal investigations.
• Work cross-functionally with Quality, Regulatory, IP, Compliance, Privacy, and other stakeholders to support process and system improvements, including development of global policies and training materials.
• Monitor and participate in the external policy environment and advise teams on policy and regulatory developments related to R&D activities.
• Manage a legal budget and ensure alignment with financial targets.
• Manage outside counsel who provide services in support of this role.
• Provide training to management and employees on emerging and/or hot legal topics.

Director, Senior Counsel, Global R&D Compliance

Legal Counsel – Privacy

General Counsel

Senior Counsel, Transactions

Associate Counsel, Contracts