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Labeling Specialist

2 months ago

Burlington, Ontario, Canada BI Canada Ltd Full time
The Role

As a Labeling Specialist at BI Canada Ltd, you will play a crucial role in supporting the development of labeling components for submissions. You will work closely with the assigned RA product responsible colleagues in DRA to ensure that marketed product labeling is compliant with local regulations and global requirements. Your expertise will be essential in developing artwork in the most efficient manner to meet submission timelines.

Key Responsibilities
  • Collaborate with the RA product responsible colleague to prepare and format all labeling documentation required for HC Submissions.
  • Review and format all packaging components, including package inserts and container labeling, and ensure that changes are implemented consistently across brands.
  • Prepare timely and accurate History Sheets for marketed products to track labeling revisions.
Innovation
  • Liaise with Artwork Specialists and other OPUs to understand systems and timelines and provide innovative solutions to generate artwork efficiently.
  • Identify gaps in processes and develop new best practice guides to lead the implementation of continuous system improvements.
Stakeholder Engagement
  • Communicate with Translation to ensure bilingual artwork for all labeling components and Product Monograph is available in time for submission.
  • Distribute Product Monograph to internal stakeholders and Communications team to ensure timely posting of labeling information on internal and external BI websites.
Requirements
  • Bachelor's degree in life science and/or computer science.
  • Work experience in the pharmaceutical industry/health authority (2-5 years) is required.
  • Certificate in Canadian Drug Regulatory Affairs from a recognized institution is an asset.
  • Excellent proofreading/editing skills and knowledge of medical and regulatory terms.
  • Excellent communication and interpersonal skills in a collaborative environment.
  • Excellent organizational and project management skills, with the ability to multitask and meet tight timelines.
Total Rewards

We offer a competitive salary, generous paid time off, comprehensive benefits plan, Defined Contribution Pension Plan, Employee and Family Assistance Plan, and programs to support overall health and wellness.

Visit our website to learn more about our company culture and benefits.