Global Labelling Strategy Manager V&i

2 weeks ago

Mississauga, Canada AstraZeneca Full time

Join the Vaccines and Immune Therapies (V&I) group at AstraZeneca, where we are pushing the boundaries of science to deliver life-changing medicines to patients. As the Global Labelling Strategy Manager, you will be responsible for the development and implementation of global labelling strategies for our developmental and commercialised products within the V&I portfolio.

**Accountabilities**:
In this role, you will lead the Product Labelling Team in the development and maintenance of high-quality Core Product Information (CPI), EU Quality review of Documents (QRD), US Prescribing Information (PI), Patient Information Leaflets (PIL) and Instructions for Use (IFU). You will support the development of the labelling strategy by interpreting regulations, guidance, and competitor analyses. You will provide labelling expertise to Regulatory Affairs colleagues, cross-functional teams, and AstraZeneca marketing companies. You will also contribute to the development of labelling negotiation strategies, anticipating HA perspectives.

**Essential Skills/Experience**:

- Bachelor’s degree in a science or related field, along with 3 + years of experience
- Relevant pharmaceutical experience, including regulatory experience
- Excellent verbal and written communication skills
- Ability to assimilate clinical and scientific information and present it in a concise manner to varied audiences
- Keen attention to detail and accuracy
- Ability to think strategically; appropriately assess and formulate strategies to manage risk
- Demonstrate proficiencies in building relationships, interpersonal awareness, critical information seeking, rational persuasion and negotiations skills

**Desirable Skills/Experience**:

- Knowledge of labelling regulations and guidance
- Experience in labelling development and/or maintenance, including for vaccines or other antibacterial/antiviral products
- Advanced academic degree (PharmD, PhD) or specialized training

At AstraZeneca, we are changemakers on the world stage at an exciting frontier of medicine. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises. We are great teammates, investing in ground-breaking collaborations, local partnerships, and commercial initiatives. We encourage and value alternative perspectives as a path to challenge the norm and push the boundaries of science. Our diversity - in culture, language, geography, skills and experience - powers us to serve the global populations we seek to develop medicines for. We optimise the potential of science, engineering next-generation vaccines with the potential to generate effective and long-lasting immune responses.

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