Lom - International Associate (labeling)

Pfizer Pfizer · Pharma · Hanoi, Vietnam

This role supports Labeling Managers by maintaining documentation in labeling systems, workflow management tools, and mailboxes to ensure compliance with SOP requirements. Responsibilities include ad hoc support for labeling deliverables, proof-reading, and system data integrity checks. The role requires knowledge of labeling principles, regulatory requirements, and proficiency with systems and structured data.

What you'd actually do

  1. Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes.
  2. Ad hoc support for labeling deliverables.
  3. Proof-reading of labeling text.
  4. System data integrity and quality checks.

Skills

Required

  • Knowledge of the principles and concepts of labeling
  • Knowledge of key regulatory and labeling principles and local regulations
  • Proficient in use of systems consistent with business expectations
  • Fluency in English language
  • Clear and effective written and verbal communications
  • Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes
  • Experience working with structured data
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
  • Demonstration of attention to detail and problem-solving skills
  • Proven technical aptitude and ability to quickly learn new software, regulations and standards

Nice to have

  • multi-language skills
  • Life sciences, pharmacy graduate or equivalent
  • equivalent relevant professional experience
  • ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products)
  • perspective of a Country office or Regional Regulatory Strategy
  • perspective of the implications of a CDS on LPDs

What the JD emphasized

  • Knowledge of key regulatory and labeling principles and local regulations
  • Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures
  • Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables
  • Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
  • Demonstration of attention to detail and problem-solving skills.
  • Proven technical aptitude and ability to quickly learn new software, regulations and standards.