Pacer Group
4 days ago Be among the first 25 applicants
Direct message the job poster from Pacer Group
Director-Client Services, Delivery and Operations
Job Title: PRC Submission Management Lead Duration:
06 Months Location: Foster City, CA 94404 (Hybrid) Description: 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 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. • Triaging and managing review comments from MLR teams, including 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 Gilead’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: a. Experience in Medical, Legal, and Regulatory (MLR) review process b. Proficiency in Veeva Vault PromoMats c. Project Management and workflow optimization Top 3 Nice to Have Skill Sets: a. Documentation and process mindset b. Change Management c. Familiarity with AI Unique Selling Point of this role: a. 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: • 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 Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Science Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Pacer Group by 2x Quality Assurance & Regulatory Affairs Manager
Redwood City, CA $124,000 - $171,000 6 days ago Santa Clara, CA $129,000 - $147,000 1 month ago Senior Regulatory Affairs Specialist – Vascular (on-site)
Regulatory Affairs Manager – Heart Failure (on-site)
Pleasanton, CA $112,000 - $224,000 1 month ago Sr. Staff Technical Program Manager, R&D Regulatory Compliance
Mountain View, CA $166,000 - $271,000 5 days ago Regulatory Affairs Manager – Vascular (on-site)
Santa Clara, CA $112,000 - $224,000 2 months ago Program Manager, Regulatory Compliance - US Governance
San Francisco, CA $57.70 - $72.60 2 weeks ago Manager, Regulatory Affairs - Shockwave Medical
Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Alameda, CA $112,000 - $224,000 2 months ago Program Manager, Regulatory Compliance - US Governance
Mountain View, CA $57.70 - $72.60 2 weeks ago Redwood City, CA $124,000 - $171,000 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Job Title: PRC Submission Management Lead Duration:
06 Months Location: Foster City, CA 94404 (Hybrid) Description: 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 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. • Triaging and managing review comments from MLR teams, including 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 Gilead’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: a. Experience in Medical, Legal, and Regulatory (MLR) review process b. Proficiency in Veeva Vault PromoMats c. Project Management and workflow optimization Top 3 Nice to Have Skill Sets: a. Documentation and process mindset b. Change Management c. Familiarity with AI Unique Selling Point of this role: a. 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: • 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 Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Science Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Pacer Group by 2x Quality Assurance & Regulatory Affairs Manager
Redwood City, CA $124,000 - $171,000 6 days ago Santa Clara, CA $129,000 - $147,000 1 month ago Senior Regulatory Affairs Specialist – Vascular (on-site)
Regulatory Affairs Manager – Heart Failure (on-site)
Pleasanton, CA $112,000 - $224,000 1 month ago Sr. Staff Technical Program Manager, R&D Regulatory Compliance
Mountain View, CA $166,000 - $271,000 5 days ago Regulatory Affairs Manager – Vascular (on-site)
Santa Clara, CA $112,000 - $224,000 2 months ago Program Manager, Regulatory Compliance - US Governance
San Francisco, CA $57.70 - $72.60 2 weeks ago Manager, Regulatory Affairs - Shockwave Medical
Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Alameda, CA $112,000 - $224,000 2 months ago Program Manager, Regulatory Compliance - US Governance
Mountain View, CA $57.70 - $72.60 2 weeks ago Redwood City, CA $124,000 - $171,000 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr