ProKidney Corp.

Compliance

• Lead or support validation projects, including the planning, execution, and documentation of computer system validation deliverables.
• Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents).
• Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs.
• Review and approve validation deliverables authored by internal teams and external vendors.
• Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems.
• Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment.
• Lead or support the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies.
• Conduct and/or support audits of IT systems, vendors, and validation documentation.
• Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews.
• Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions.
• Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented.
• Perform system risk assessments to determine GxP classification and validation requirements.
• Participate in vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments.

Manager, IT Assurance and Compliance

Medical writer

• Prepares, edits, reviews, and finalizes regulatory documents and related clinical documents of all complexity levels
• Provides conceptual contributions to projects; participates and contributes to regulatory and clinical development strategy, as needed
• Leads cross-functional teams in document preparation, including but not limited to, development of content strategy, coordination of content contributions, development and maintenance of applicable timelines
• Collaborates with cross-functional team to interpret study results and ensure messaging is consistently reflected across relevant regulatory documents
• Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
• Ensures that medical writing deliverables are compliant with International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Create, maintains, and ensure corporate compliance with standard operating procedures and work instructions for applicable clinical regulatory deliverables
• Proactively identifies and subsequently leads initiatives that improve quality, efficiency, and productivity of medical writing processes and templates
• Contribute to vendor oversight as needed
• May serve as functional area representative
• Participate in interdepartmental activities as deemed necessary

Medical Writer – Contractor

Technical Project Manager

• Project Leadership – Manage the full lifecycle of IT projects from planning through deployment, including requirements gathering, design, testing, go-live, and post-implementation support.
• Cross-Functional Collaboration – Lead and motivate cross-functional teams, fostering clear communication and accountability to ensure deliverables are met on time and within scope.
• Vendor & Stakeholder Management – Coordinate with internal stakeholders and external vendors; hold all parties accountable for timely completion of project tasks and milestones.
• Requirements Translation – Facilitate business requirements sessions, translate needs into actionable project plans, and manage change requests effectively.
• Risk & Issue Management – Proactively identify, assess, and mitigate project risks; escalate critical issues promptly with recommended solutions.
• Progress Tracking & Reporting – Maintain detailed project documentation, track progress against milestones, and provide weekly status reports to leadership.
• Validation Expertise – Support GxP validation and 21 CFR Part 11 compliance activities, ensuring documentation and testing meet regulatory and quality standards.
• Meeting & Event Coordination – Organize and facilitate key project events including system demos, document reviews, and testing sessions.
• Process Expertise – Develop and maintain deep knowledge of IT project management and GxP validation processes to guide teams effectively.
• Travel & Onsite Support – Be available during core business hours (9:00 am – 5:00 pm EST) and travel to company sites for critical project phases.

IT Project Manager – Contractor

• Lead the full lifecycle of IT projects from planning through deployment, including requirements gathering, design, testing, go-live, and post-implementation support.
• Cross-Functional Collaboration – Lead and motivate cross-functional teams, fostering clear communication and accountability to ensure deliverables are met on time and within scope.
• Vendor & Stakeholder Management – Coordinate with internal stakeholders and external vendors; hold all parties accountable for timely completion of project tasks and milestones.
• Requirements Translation – Facilitate business requirements sessions, translate needs into actionable project plans, and manage change requests effectively.
• Risk & Issue Management – Proactively identify, assess, and mitigate project risks; escalate critical issues promptly with recommended solutions.
• Progress Tracking & Reporting – Maintain detailed project documentation, track progress against milestones, and provide weekly status reports to leadership.
• Validation Expertise – Support GxP validation and 21 CFR Part 11 compliance activities, ensuring documentation and testing meet regulatory and quality standards.
• Meeting & Event Coordination – Organize and facilitate key project events including system demos, document reviews, and testing sessions.
• Process Expertise – Develop and maintain deep knowledge of IT project management and GxP validation processes to guide teams effectively.
• Travel & Onsite Support – Be available during core business hours (9:00 am – 5:00 pm EST) and travel to company sites for critical project phases.

Manager, IT Assurance and Compliance

Medical Writer – Contractor

IT Project Manager – Contractor

IT Project Manager - Contractor