PRC Submission Management Lead
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Job Location:
Foster, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions tour clients world-wide. The below job opportunity is with one of our Biotech clients whresearches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: PRC Submission Management Lead
Location: Foster City CA 94404
Duration: 5 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Description:
- The 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 the clients AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications
- Proven experience in 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:
- 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
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Key Skills
- Healthcare Attorney
- Cyber Security
- Basic
- Legal Operations
- Housekeeping
