Provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables
Responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs
Working with Global Regulatory Lead, responsible for the development of integrated regulatory plan and ensures alignment with the overall strategic and operational plan for the asset
Offers leadership in regulatory strategy and planning, including development and assessment of scenarios and options, robust decision criteria, risk management, and internal/external communication and stakeholder management strategies
Develop regulatory goals in partnership with the Global Regulatory Lead and closely monitors progress against these goals for operational efficiency ensuring the program delivers on time and within scope
Ensures effective, accurate, and timely communication of regulatory information to meet the needs of the product team and stakeholders
Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations

Requirements

Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience
Command of program management skills and considerable expertise in drug development (Oncology preferred)
Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable
Experience with the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is preferred
Track record of performance, delivery and team effectiveness in a complex matrix team environment
Proven ability to drive results
Knowledge and experience in drug development, medical, and/or commercial disciplines
Demonstrated ability to translate strategy into effective operational goals and tactical plans
Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
Knowledge of and experience with clinical operations/clinical trial execution is desirable
Knowledge of end-to-end drug development (pre-clinical through LOE) is desirable
Experience with Microsoft Project, Planisware, and/or OnePager is preferred.

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Paid holiday
Paid personal days
Paid caregiver/parental leave
Paid medical leave
Health benefits including medical, prescription drug, dental, and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

program managementdrug developmentregulatory submissionsNDABLAMAArisk managementoperational efficiencyclinical operationsend-to-end drug development

Soft Skills

leadershipnegotiationinterpersonal skillscommunicationmeeting facilitationteam effectivenessstrategic planningtactical planningstakeholder managementperformance delivery

Certifications

Project Management Professional (PMP)