LOM Job Responsibilities:
- 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.
- Provides Shadowing Opportunity to the Associate I LOM's
Education Qualifications:
- Bachelor’s degree required preferably in a science or life sciences related degree.
- 0-2 years practical experience
Work Location Assignment: Flexible
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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