Associate Ii Labeling Operations
3 days ago
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
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
-
Associate I
2 weeks ago
Chennai, India Pfizer Full timeThe 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...
-
Associate I Labeling Operations
1 week ago
Chennai, India Pfizer Full timeThe 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...
-
Operations Associate Ii
3 days ago
Chennai, India Wolters Kluwer Full timeJob Identification Position Title: GCF Level: Operations Associate II B2 Function: Operations/Supply Chain > Operations - Generalist **Location**: Chennai Business Unit: TAA XCM Supervisory Relationships Reports To: Operations Lead - Basic Function Requires in-depth conceptual and practical knowledge with in the Financial Accounting job family group. As a...
-
ML Data Associate-II
1 day ago
Chennai, India ADCI MAA 12 SEZ Full timeAI is the most transformational technology of our time, capable of tackling some of humanity’s most challenging problems. Amazon is investing in generative AI and the responsible development and deployment of large language models (LLMs) across all of our businesses. Come build the future of human-technology interaction with us.We are looking for those...
-
Associate Ii, Cdm
4 days ago
Chennai, India Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
ML Data Associate-II
3 weeks ago
Chennai, India Amazon Full timeThis job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DESCRIPTION: AI is the most transformational technology of our time, capable of tackling some of humanity's most challenging problems. Amazon is investing in generative AI and...
-
IT Support Associate Ii, IT Services
4 days ago
Chennai, India ADCI - Tamil Nadu Full timeBachelor’s degree or Diploma in any discipline. - Total 2+ years of experience in IT support domain includes asset management. - Hands on experience in Windows. - Should be capable to complete the task following the standard operating procedure. - Should have experience in understanding IT equipment’s, peripherals and IT Warehouse. - Should have...
-
Labelling Business Analyst
3 weeks ago
Chennai, India Dxc Technology Full timeJob Description Key Responsibilities - Minimum 8 years of experience in Operate and manage labelling projects using platforms like Labelbox (or similar tools). - Configure and maintain labelling workflows, templates, and quality assurance processes. - Collaborate with data scientists and ML engineers to define labelling requirements and guidelines. - Perform...
-
ML Data Associate-II
1 week ago
Chennai, Tamil Nadu, India Amazon Full time ₹ 9,00,000 - ₹ 12,00,000 per yearAI is the most transformational technology of our time, capable of tackling some of humanity's most challenging problems. Amazon is investing in generative AI and the responsible development and deployment of large language models (LLMs) across all of our businesses. Come build the future of human-technology interaction with us.We are looking for those...
-
ML Data Associate-II
3 days ago
Chennai, India Amazon Full timeJob Description Description AI is the most transformational technology of our time, capable of tackling some of humanity's most challenging problems. Amazon is investing in generative AI and the responsible development and deployment of large language models (LLMs) across all of our businesses. Come build the future of human-technology interaction with us....