Labelling Specialist

3 months ago

Burlington, Canada BI Canada Ltd Full time

**The Position**:
Support development of all labeling components for submissions, in conjunction with the assigned RA product responsible colleagues in DRA. 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**:
**Key Responsibilities**
- Collaborate with the assigned RA product responsible colleague to prepare/format all labeling documentation required for HC 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)

This position is based in the Burlington, Ontario office located at 5180 South Service Road and is **flexible **.
Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.

**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 recognized institution is an asset.
- Knowledge of written and spoken French is an asset.
- Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation).
- Excellent communication and interpersonal skills in a strongly collaborative, multi
- stakeholder environment.
- Excellent organizational (project management skills), planning and follow-up skills. Able to meet tight timelines, efficient, detail oriented with knowledge of medical and regulatory terms, flexible and self-motivated. Must have basic problem-solving skills, both from a technical and procedural perspective. Ability to multitask projects.
- High level ability to demonstrate agility in delivering results with fast and focused execution in a dynamic environment by adapting to changing priorities.Continuously evaluates innovative opportunities to improve efficiency and execution of process.

**Total Rewards**:
We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.

**READY TO APPLY?**:
Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.

**DEADLINE FOR APPLICATIONS**:
Applications for this position will be accepted until October 4, 2024.

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