Job title: PRC Submission Management Lead
Location: Foster City, CA
Duration: 06+ Months
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 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
...efficiency and cost reductions. The Design Engineering co-op assists in the development and design of tools, fixtures and other devices used for production based on engineering specifications. The Process Engineering co-op is responsible to ensure the manufacturing...
...Meat Cutter/Butcher Position Available Employer has an opening for a meat cutter/butcher. Will be working in a meat processing plant. Must be able to lift 50 pounds. Work around live animals. Must be able to work with saws and knives. Will be butchering cattle, sheep...
...the World. From operational leadership and crew planning to safety and service procedures... ..., training and guidance needed for our flight attendants to deliver the best possible customer... ...and responsibilitiesInflight Crew Schedulers ensure that all flights in our reliable...
...Description ***MUST HAVE YOUR CDL CLASS B / CLASS A with Endorsements Air Brakes, Passenger, School Bus*** Overview A school bus driver is responsible for safely transporting students to and from school and school-related activities. This role requires adherence to...
...Job Description Ethos Medical Staffing is seeking a travel nurse RN OR - Operating Room for a travel nursing job in Socorro, New Mexico. Job Description & Requirements ~ Specialty: OR - Operating Room ~ Discipline: RN ~ Start Date: 11/10/2025~ Duration...