Labeling Specialist (1 year Contract)
Boehringer Ingelheim
Burlington, Ontario, CA
10d ago

Description :

Support development of all labeling components for submissions, in conjunction with the assigned product responsible colleagues in Drug Regulatory Affairs.

Ensure marketed product labeling is set up to be compliant with local regulations and global requirements (Corporate Design) and artwork is developed in the most efficient manner to meet submission timelines.

Responsibilities :

  • Collaborate with the assigned Regulatory Affairs product responsible colleague to prepare / format all labeling documentation required for Health Canada Submissions in time for submission compilation.
  • Responsible for reviewing / formatting all packaging components (package insert, container labeling) and proofreading, implementation, and change control for all submissions.
  • Ensure changes are implemented consistently across brands.
  • Prepare timely and accurate History Sheets for marketed products to track labeling revisions for A) artwork version tracking and B) historical revision documentation.
  • INNOVATION

  • Liaise with Artwork Specialist and other OPUs (i.e. US) to have complete understanding of systems and timelines to provide innovative solutions to generate artwork in most efficient and timely manner.
  • Identify gaps in processes and scope; develop new best practice guides, lead implementation of continuous system improvements, maintain and enhance workflow tools used for electronic routing and approval of labeling change requests.
  • Stakeholder Engagement

  • Communicate via established procedures with Translation to ensure bilingual artwork for all labeling components and Product Monograph is available in time for submission.
  • Distribution of Product Monograph to internal stakeholders as per established procedures and distribution to Communications team to ensure timely posting of labeling information on the internal / external BI websites.
  • Liaise with potential vendors (SPL).
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