Associate 1 Labeling Operations

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Chennai, Tamil Nadu
Hybrid
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
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.
  • Create/Update 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.

Here Is What You Need (Minimum Requirements)
  • Bachelor's degree required preferably in a science / life sciences related degree.

- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Basic understanding of regulatory requirements for labeling
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team
- Ability to manage multiple tasks simultaneously
- Basic project management skills
Bonus Points If You Have (Preferred Requirements):
- Knowledge of global labeling regulations
- 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

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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Typical time on-site: Not Specified
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