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Global Labelling Strategy Manager – Vaccines and Immune Therapies
4 weeks ago
The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilising our expertise in virology, microbiology, and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms. Within V&I Regulatory Affairs, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
About the role:
The Labelling Strategy Manger is responsible for the development and implementation of the global labelling strategies for assigned developmental and commercialised products within the V&I portfolio. The Labelling Strategy Manager applies knowledge of global and local labelling requirements and trends to ensure that essential information regarding the safe and effective use of our products is available to healthcare professionals and patients.
What you will do:
Lead the Product Labelling Team (PLT) 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) through Senior Leader approval
Contribute to the development of the labelling strategy by interpreting regulations, guidance, and competitor analyses, anticipating, and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider V&I portfolio
Provide labelling expertise to Regulatory Affairs colleagues, cross-functional teams, and AstraZeneca marketing companies, regarding language, placement and regulatory content detail for CPI and market-specific product information, in line with company procedures, regional labelling regulations and guidance
Contribute to the development of labelling negotiation strategies, anticipating HA perspectives.
Provide clarity regarding applicable labelling requirements, expectations, risks, and mitigations for complex situations to relevant stakeholders
Evaluate, interpret, and communicate global regulations and trends on labelling and any business impact these might have on product labelling
Develop and communicate the rationale for labelling strategies to Senior Leaders to enable effective decision making
Contribute to the development of target product labelling (TPL) documents
Contribute to the development of the labelling team by sharing knowledge and mentoring peers
Assist in the development of labelling policies, procedures and SOPs
Must haves:
Bachelor’s degree (or equivalent) in a science or related discipline
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 competencies 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
Great People want to Work with us Find out why:
Are you interested in working at AZ, apply today
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .
Date Posted
29-May-2024Closing Date
27-Jun-2024-
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