[New Job Vacancy] job in Pfizer, (abb04ac11287cca2) – Jobs in abb04ac11287cca2

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Job Category :
 General jobs

Full Job Description :-
The Labeling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.
The LOM will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.
The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.
The LOM, Senior Associate A will provide operational support for medium complexity projects:
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. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
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.
Provides shadowing opportunity to the trainee LOM’s
Update related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
Education Qualifications:
Bachelor’s degree in a science or life sciences required
3+ years experience in a regulated environment; pharmaceutical labeling experience preferred.
Experience and Attributes:
Excellent written and verbal communication skills essential.
Complete fluency in English Language.
Proven strength in logical, analytical and writing ability essential.
Identifies and resolves problems in a proactive manner.
Has strong knowledge/understanding of the principles and concepts of the discipline
Knowledge of global/regional regulatory guidelines and requirements important.
Project Management capability and organizational skills:
Demonstrated project management skills and attention to detail required.
Ability to assess and manage project timelines.
Ability to multi-task, prioritize and manage multiple projects.
Ability to identify and resolve problems in a proactive manner.
Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
Participates and contributes as a team member
Interpersonal and communication skills:
Clear and effective written and verbal communication skills.
Ability to liaise with stakeholders using effective means of communication.
Makes decisions toresolve moderately complex problems in standard situations
Makes decisions within guidelines and policies
Able to work in ambiguous situations as part of a Work Team
Decisions have short-term effect on the delivery of scheduled programs/projects
Uses own judgment to modify standard methods and techniques when necessary
Technical Skills
High attention to detail.
Ability to apply labeling regulatory guidance on formatting requirements.
Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
Knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.
Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
May act as a technical resource within own Work Team
Understands the fundamental business drivers for the company.
Systems and Document compilation skills, including:
Must have excellent computer skills and be proficient with Microsoft Word and similar applications.
Prepare submission ready documents.
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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