Vice President | Head of Regulatory Compliance

Our client conducts outpatient clinical trials across a network of seven (7) owned clinical trial sites in California, Nevada and Texas. They enroll patients in general medicine clinical trials across multiple therapeutic areas ("TA") including gastroenterology, neurology, obesity, pain, vaccines and women's health with the support of its 20+ principal investigators and sub-investigators.

Key Responsibilities

• Regulatory Strategy Development : Develop and implement comprehensive regulatory strategies to ensure compliance with all applicable laws and regulations governing clinical research activities.
• Policy and Procedure Oversight : Oversee the creation, implementation, and maintenance of regulatory policies and procedures to ensure they are up-to-date and in line with current regulations.
• Compliance Monitoring : Establish and maintain systems for monitoring compliance with regulatory requirements, including regular audits and inspections of clinical research sites.
• Risk Management : Identify potential regulatory risks and develop mitigation strategies to address them proactively.
• Training and Development : Lead the development and delivery of training programs for staff on regulatory compliance topics to ensure a high level of understanding and adherence to regulatory requirements.
• Stakeholder Engagement : Serve as the primary point of contact for regulatory agencies and other external stakeholders, ensuring effective communication and collaboration.
• Regulatory Submissions : Oversee the preparation and submission of regulatory documents, including clinical trial applications, amendments, and annual reports.
• Performance Metrics : Develop and track key performance indicators (KPIs) to measure the effectiveness of the regulatory compliance program and identify areas for improvement.
• Quality Control : Implement and maintain quality control measures to ensure the integrity and reliability of clinical research data. This includes establishing quality assurance processes, conducting regular audits, and ensuring that all research activities meet the highest standards of quality and compliance.

Key Requirements

Location : TX, CA, AZ, Nevada

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