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
...CONTRACTS SPECIALIST Cotton Holdings, Inc. is a global, diversified holding company headquartered in Houston, Texas. With annual revenue... ...in supporting Cotton Holdings' diverse business operations by managing contract processes across our family of companies. This...
...Registered Nurse (RN) - Women's and Children's Unit Rutland-VT-05701-United States The RN advocates and utilizes... ...the nursing process in the care of all age populations along the health continuum. The nursing process includes assessment, diagnosis, planning...
...Job Summary The security officer is responsible for the safety and security of the people, product, property and information of the Company... ...At least 5 years law enforcement or luxury security retail experience No criminal record; absolute honesty and unquestionable...
Norton Hammersley is actively seeking a real estate closer, to join our team. Position Summary Our Real Estate Paralegals assist with drafting, reviewing, editing, and managing all types of documents for the acquisition of residential and commercial properties....
...Neurology Physician Assistant Tucson, AZ Currently seeking an Neurology Physician Assistant for an opportunity in the Tucson area. Interested candidates should be NCCPA certified and needs prior neurosurgery, orthopedics, or surgery experience. Responsibilities...