AI governance and compliance through technology modernization and transformation in regulatory contexts in life sciences(biopharma,biotech,research,CRO,clinical trials etc.,)and health industries

Project Overview This freelance project seeks an experienced professional to support AI governance and compliance initiatives through technology modernization and transformation within regulatory environments in the life sciences and health industries. The focus is on ensuring effective oversight and compliance for organizations such as biopharma, biotech, research institutions, CROs, and clinical trial operations. The engagement is fully remote and based in Dallas, TX. Scope of Work Assess current AI governance frameworks and compliance processes within regulatory contexts. Develop and recommend strategies for technology modernization to enhance compliance and oversight. Conduct research and analysis on relevant regulations, standards, and best practices in life sciences and health industries. Draft and update documentation, policies, and procedures related to AI governance and compliance. Collaborate with stakeholders to identify compliance gaps and propose mitigation strategies. Support the implementation of new or updated compliance processes and technology solutions. Provide guidance on legal, regulatory, and intellectual property considerations as they relate to AI and technology transformation. Deliverables, Timeline & Success Criteria Comprehensive assessment report of current AI governance and compliance status. Strategy document outlining recommended modernization and transformation initiatives. Updated or newly developed compliance documentation, policies, and procedures. Implementation roadmap with clear milestones and timelines. Regular progress updates and stakeholder communications. Estimated project duration: 8-12 weeks, with timeline to be finalized based on project scope. Success will be measured by the delivery of actionable recommendations, clear and compliant documentation, effective stakeholder engagement, and timely completion of agreed-upon milestones. Required Skills & Qualifications Proven experience in AI governance, compliance, or regulatory affairs within life sciences, biotech, or health industries. Strong knowledge of regulatory frameworks and best practices relevant to clinical trials, biopharma, and research organizations. Expertise in technology modernization and transformation projects. Excellent research, legal writing, and documentation skills. Ability to analyze complex regulatory requirements and translate them into practical solutions. Strong communication and stakeholder management skills. Experience with intellectual property law and legal compliance is a plus. Demonstrated ability to manage projects remotely and deliver results within set timelines.