Associate I Labeling Operations

2 days ago

Chennai, India Pfizer Full time

The LOM, Associate I will provide operational support for project tasks including:

- 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.

Education Qualifications:

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

Experience and Attributes:

- Excellent written and verbal communication skills essential.
- Complete fluency in English Language.
- Proven strength in logical, analytical and writing ability essential.

Interpersonal and communication skills:

- Clear and effective written and verbal communication skills.

Technical Skills
- High attention to detail.

Systems and Document compilation skills, including:
Work Location Assignment: Remote

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

Regulatory Affairs

LI-PFE

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