Pfizer - Internal

Pfizer - Internal

πŸ“ Location: New York, New York City, United States
πŸ“ Location: Quebec, Kirkland, Canada
πŸ“ Location: Washington, Bothell, United States
πŸ“ Location: Hertzelya, Israel
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πŸ“ Location: Pennsylvania, Collegeville, United States
πŸ“ Location: N. Psychiko, Greece
πŸ“ Location: Walton Oaks, United Kingdom
πŸ“ Location: Sandwich, United Kingdom
πŸ“ Location: Connecticut, Groton, United States

Pfizer is dedicated to breakthroughs in healthcare and innovative cancer treatments.

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GCP Issue Lead Investigations

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1 week ago
πŸ’° 113K-188K USD/year
πŸ›’οΈ Workday
⏰ Full Time
πŸ’» Hybrid
🟠 Senior (5 - 7Years)
πŸͺͺ Visa sponsored
πŸ’Ή Finance Jobs
πŸ₯ Healthcare
✍️ Full Description
The Issue Lead will drive QE case management, conduct thorough investigations within timelines and compliance requirements, and oversee the efficiency of the process. They will also triage submitted cases, assess the Quality Event threshold, and manage confirmed Quality Event cases.

Requirements

  • BS – 7+ years or equivalent
  • MS/MBA – 6+ years or equivalent
  • Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
  • Regulatory inspection experience
  • Process and system management experience
  • Detailed knowledge of clinical trial processes and relationships required
  • Knowledge of GCP requirements and applicable SOPs and regulations
  • Project management, administrative, and technical capabilities are required, as well as effective verbal communication skills

Benefits

  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
  • paid vacation, holiday and personal days
  • paid caregiver/parental and medical leave
  • health benefits to include medical, prescription drug, dental and vision coverage
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