Use Your Power for Purpose

 

As an Associate in Labeling Operations at Pfizer, you will play a crucial role directly contributing to the improvement of patients' lives. Your work will ensure that our products are accurately labeled, meeting regulatory requirements and providing essential information to healthcare professionals and patients. This role offers a unique opportunity to make a tangible impact on global health while working with a team of dedicated professionals.

 

What You Will Achieve

 

In this role, you will provide operational support for Global Labeling which includes;

• Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Facilitate workflow through corporate document repository, e.g., GDMS.
• Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.).
• Manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents.
• Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).
• Responsible for ensuring compliance to Company’s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.
• Consolidate labeling versions.
• Consolidate comments from Labeling reviewers and Regulatory Authorities.
• Prepare comparison tables for labeling team discussions.
• Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
• Update and maintain the CDS log.
• Set clear targets for review and approval timelines for labeling documents using effective project management. Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree required preferably in a science / life sciences related degree.
• 0-2 years practical experience

-          Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

-          Basic understanding of regulatory requirements for labeling

-          Strong organizational skills

-          Excellent written and verbal communication skills

-          Ability to work independently and as part of a team

-          Attention to detail and accuracy

-          Ability to manage multiple tasks simultaneously

-          Basic project management skills

 

Bonus Points If You Have (Preferred Requirements):

 

-          Experience in the pharmaceutical or biotechnology industry

-          Familiarity with labeling software and databases

-          Knowledge of global labeling regulations

-          Experience with electronic document management systems

-          Strong interpersonal skills

-          Strong analytical skills

-          Ability to interpret and apply regulatory guidelines

-          Effective problem-solving skills

  
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs