Manager, Research Regulatory

OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology's mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description :

The Manager, Research Regulatory is responsible for leading a team of regulatory affairs professionals to support clinical research across the OneOncology network. The individual plays a key role in ensuring all research activities comply with regulatory requirements set forth by the Food and Drug Administration (FDA) and Institutional Review Board (IRB). The Manager, Research Regulatory will work closely with cross-functional teams for developing and implementing regulatory strategies, providing guidance and support to team members and ensuring processes adhere to legal and ethical standards. Additionally, the role will engage with various practices within our network to streamline regulatory processes and foster collaboration between teams.

Responsibilities

• Leading and managing a team of regulatory affairs professionals, providing guidance, support and mentorship as needed.
• Foster a collaborative and positive team environment, promoting open communication and teamwork.
• Monitor performance and productivity of regulatory specialists, identifying areas for improvement and implementing process enhancements to optimize regulatory operations.
• Developing and implementing regulatory strategies for clinical research and ensuring compliance with applicable regulations and guidelines.
• Keeping abreast of changes in regulations and guidelines related to clinical research and implementing changes in the regulatory process as necessary.
• In collaboration with Quality Assurance, ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements.
• Review and modify study specific informed consent forms for readability, clarification of payments, costs, and standard of care language, and to ensure that all elements required by the Food and Drug Administration (FDA) are included.
• Prepare, route, and submit essential regulatory documents to sponsors / CROs on behalf of network practices.
• Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements.
• Coordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirements.
• Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards.
• Establish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissions.
• Track and communicate regulatory submission timelines, milestones, and status updates to internal stakeholders.
• Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices.
• Stay informed about changes in regulatory requirements and industry standards and disseminate relevant information to team members.
• Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration.
• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

Qualifications

LI-AN1