Net2Source (N2S)
Submission Management Lead - Promotional Review /MLR
Net2Source (N2S), San Mateo, California, United States, 94409
Submission Management Lead - Promotional Review /MLR
Base Pay Range
$80.00/hr - $89.00/hr
Title:
Submission Management Lead - Promotional Review /MLR
Duration:
06+ months
Location:
Foster City, CA 94404 (Hybrid)
Pay rate:
$80 -$89/hr.
Position Summary Client is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, 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 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 Client's AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact‑checking
Qualifications
Proven 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
Required Years of Experience:
6-8 years
Top 3 Required Skill Sets
Experience in Medical, Legal, and Regulatory (MLR) review process
Proficiency in Veeva Vault PromoMats
Project Management and workflow optimization
Top 3 Nice to Have Skill Sets
Documentation and process mindset
Change Management
Familiarity with AI
Unique Selling Point of this Role
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
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
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Title:
Submission Management Lead - Promotional Review /MLR
Duration:
06+ months
Location:
Foster City, CA 94404 (Hybrid)
Pay rate:
$80 -$89/hr.
Position Summary Client is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, 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 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 Client's AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact‑checking
Qualifications
Proven 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
Required Years of Experience:
6-8 years
Top 3 Required Skill Sets
Experience in Medical, Legal, and Regulatory (MLR) review process
Proficiency in Veeva Vault PromoMats
Project Management and workflow optimization
Top 3 Nice to Have Skill Sets
Documentation and process mindset
Change Management
Familiarity with AI
Unique Selling Point of this Role
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
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
#J-18808-Ljbffr