Labelling Proofreader

3 weeks ago

Mississauga, Canada AstraZeneca Full time

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and _BlueSky Hub_ in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Our position**:
**Accountabilities/Responsibilities**:

- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Ensures timely QC check of all labelling documents for US and EU, this includes proofing, copy editing and formatting of documents.
- Ensures timely QC check and review of all packaging components for US
- Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
- Provide support to Labelling Strategist with regards to labeling documents for submission.
- Provide support to Labelling Artwork manager with regards to packaging components for submission and implementation.
- Provide mentorship to labeling teams regarding regulatory technical requirements for regional labeling submissions
- As requested, assist in maintaining repository of current labeling documents and with uploading of documents to electronic document management system.
- Supports with Documents/tracks changes as required, using designated spreadsheets/logs for label version control, other document control, and always maintaining accurate, auditable databases and files
- Handling component code updates
- Provide support across the group for specific data entry and collation of information

**Your skills and capabilities**:

- University Degree in Science or related field
- 1 to 3 (depending on role) pharmaceutical experience, preferably regulatory experience, preferably working with labeling & packaging/artworks.
- Experience in a proofreading capacity.
- Excellent written and verbal communication skills in English.
- Knowledge of labeling regulations and guidances.
- Keen attention to detail and accuracy.
- Excellent verbal and written communication skills.
- Multi-cultural awareness and sensitivity; proven experience in communicating and negotiating in diverse cultures.
- Must demonstrate competencies in:

- Building Relationships, Critical Information Seeking & Interpersonal Awareness.

**Great People want to Work with us Find out why**:
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is a crucial requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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