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PRC Submission Management LeadIntegrated Resources, Inc ( IRI ) • Foster City, CA, US
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PRC Submission Management Lead
Integrated Resources, Inc ( IRI ) • Foster City, CA, US
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionProven experience in US Commercial Regulatory Affairs, specifically within PRC / MLR review operations. Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking. Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams. Experience working with agencies and internal content teams to resolve feedback and ensure compliance. Operational mindset with the ability to streamline processes, identify gaps, and implement best practices. Prior experience in training and documentation development is a plus. Familiarity with AI applications in regulatory or marketing contexts is a bonus. Experience in Medical, Legal, and Regulatory (MLR) review process Proficiency in Veeva Vault PromoMats Project Management and workflow optimization Documentation and process mindset Change Management Familiarity with AI Veeva Vault Certification or Training – demonstrating proficiency in the platform Project Management Certification (e.g., PMP) – helpful for managing review cycles and cross-functional coordination
Delivery Lead – Recruitment at Integrated Resources, Inc (IRI)
Compensation : $72 / hr - $80 / hr
Job Title : PRC Submission Management Lead
PRC Submission Management Lead – a seasoned professional to support the CPC team. This specialized role requires deep expertise in Medical, Legal, and Regulatory (MLR) review and approval, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Key Responsibilities
- Serve as a Subject Matter Expert (SME) in the US CPC team, ensuring compliance with regulatory standards and internal processes.
- Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault.
- Attend PRC meetings to represent submission status, clarify content, and capture feedback.
- Triage and manage review comments from MLR teams, coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure.
- Conduct reference checks prior to PRC submission / routing to ensure accuracy and completeness.
- Provide training and guidance to CPC team members on regulatory guidelines and best practices.
- Develop a playbook outlining optimal ways of working across PRC and CPC teams.
- Collaborate with the client's AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications
Required Years of Experience
6-8 years
Top 3 Required Skill Sets
Top 3 Nice to Have Skill Sets
Unique Selling Point
The position is ideal for someone who wants to influence enterprise-level change, contribute to next-generation regulatory solutions, and work in a high-impact, cross-functional environment that values both subject-matter expertise and operational agility.
Required Degree or Certification
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
J-18808-Ljbffr
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Submission Management • Foster City, CA, US
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