Senior Regulatory Project Manager for Oncology

$109,400 - $182,300/Yr

Pfizer - San Diego, CA

Full-time - Senior

San Diego, CA

Chemical Manufacturing

About the position

The Senior Regulatory Project Manager for Oncology at Pfizer is responsible for overseeing and managing the operational aspects of ongoing regulatory oncology projects. This role acts as a liaison between project teams and line management, ensuring effective communication and project progress. The manager will support programs by managing project status, budgets, schedules, and preparing reports, while also developing mechanisms for monitoring project progress and resolving issues to meet productivity and quality goals.

Responsibilities

• Develop ideas, manage plans to achieve objectives and lead or co-lead projects across the division.
• Facilitate the development, implementation and management of business strategies.
• Manage the development of the project plan with cross functional teams to deliver the program on time, within schedule, and within budget.
• Develop and execute communication plan to ensure effective and timely communication between the core team and functional management, senior management, and external partners.
• Prepare periodic management and progress reports.
• Promote a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity.
• Provide project information necessary to support portfolio-level decision making and prioritization.
• Coordinate and ensure long-range needs for expansion of production equipment, identify novel upstream and downstream processes and assimilate them into the relevant work streams.
• Capitalize on the foundation of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of analytic and modeling tools.
• Monitor team performance and proactively alert team and management about deviations from plan.

Requirements

• Bachelor's Degree
• 7+ years of experience leading projects in a highly regulated environment
• Cross-functional project management experience
• Knowledge of drug development including a thorough understanding of the processes associated with feasibility, clinical study start-up and business operations
• Outstanding project management and organizational skills
• Excellent presentation and communication skills
• Experience successfully managing multiple projects with multiple deadlines
• Knowledge of the pharmaceutical manufacturing and associated processes
• Experience in a Pharmaceutical Good Manufacturing Practices/cGMP environment
• Familiarity with Pharmaceutical Sciences infrastructure

Nice-to-haves

• Experience with product development processes within a pharmaceutical or medical device company
• Oncology experience preferred
• Familiarity with clinical trial execution, working with contract research organizations, budget management, and related areas
• Experience leading regulatory submissions for drug applications
• Experience with Microsoft Project, Planisware, and/or OnePage
• Project Management Professional (PMP) certification

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage
• Participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary
• Eligibility to participate in share-based long-term incentive program
• Relocation assistance may be available based on business needs and/or eligibility