Pfizer

Senior Manager, Labeling Operations

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: New York City • New York • United States

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Salary

💰 $124,400 - $207,400 per year

Job Level

Senior

About the role

  • Provide operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC)
  • Lead and manage the review and delivery of CDS, USPI, SPC and associated Patient Labeling Documents
  • Edit and format labeling documents according to internal and external guidance
  • Independently manage updates for related labeling documents
  • Coordinate and manage the Quality review process ensuring timelines are met
  • Generate necessary renditions and communicate with key stakeholders on labeling updates

Requirements

  • Bachelor’s degree in a science or life sciences required
  • 6+ years of experience in a regulated environment with a Bachelor’s degree OR 5+ years of experience with a Master’s Degree
  • 4+ years pharmaceutical labeling experience
  • Knowledge of global/regional regulatory guidelines and requirements
  • Excellent written and verbal communication skills essential.
  • Complete fluency in English Language.
  • Proven strength in logical, analytical and writing ability essential.
  • Demonstrated project management skills and attention to detail required.
Benefits
  • 401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday, and personal days
  • Paid caregiver/parental and 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
labeling documentsCore Data Sheets (CDS)United States Package Inserts (USPI)Summary of Product Characteristics (SPC)Quality review processproject managementeditingformatting
Soft Skills
written communicationverbal communicationanalytical abilityattention to detail
Certifications
Bachelor’s degreeMaster’s degree