ROLE SUMMARY
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 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.
ROLE RESPONSIBILITIES
Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
• 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)
• 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.
• Utilize PfLEET2 to track labeling projects
• 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).
• The LOM will be responsible for updating related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
• 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.
• Update and maintain the CDS log.
• Identify and assist teams to overcome barriers in achieving quality and compliance.
• 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.
• Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
• Contribute to the development of continuous improvement of business practices. Advocate for new labeling initiatives to immediate labeling stakeholders
Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
• 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)
• 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.
• Utilize PfLEET2 to track labeling projects
• 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).
• The LOM will be responsible for updating related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
• 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.
• Update and maintain the CDS log.
• Identify and assist teams to overcome barriers in achieving quality and compliance.
• 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.
• Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
• Contribute to the development of continuous improvement of business practices. Advocate for new labeling initiatives to immediate labeling stakeholders
Candidate Profile
Bachelor’s degree required; science or life sciences field of study preferred.
Experience and Attributes:
• 2+ years experience in pharmaceutical or medical device industry required; pharmaceutical labeling experience preferred.
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
Technical Skill Requirements
• 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
• Interpersonal and communication skills
• Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills.
Technical competencies
• Ability to apply labeling regulatory guidance on formatting requirements
• High attention to detail
• Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes)
Systems and Document compilation skills, including:
• Must have excellent computer skills and demonstrated proficiency with Microsoft Word and similar applications
• Prepare submission ready documents
• Hyperlinking, pagination, Table of Contents (TOC) creation, etc.
• Project Management capability and organizational skills
Bachelor’s degree required; science or life sciences field of study preferred.
Experience and Attributes:
• 2+ years experience in pharmaceutical or medical device industry required; pharmaceutical labeling experience preferred.
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
Technical Skill Requirements
• 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
• Interpersonal and communication skills
• Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills.
Technical competencies
• Ability to apply labeling regulatory guidance on formatting requirements
• High attention to detail
• Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes)
Systems and Document compilation skills, including:
• Must have excellent computer skills and demonstrated proficiency with Microsoft Word and similar applications
• Prepare submission ready documents
• Hyperlinking, pagination, Table of Contents (TOC) creation, etc.
• Project Management capability and organizational skills
Additional Information
Qualification : B.Sc
Experience : 2+ years
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th December, 2018
Qualification : B.Sc
Experience : 2+ years
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th December, 2018
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