Global Labeling Strategy Associate Director V&I Therapies

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Are you a collaborative and confident labeling strategist wanting to be at the heart of where science, clinical evidence, regulatory requirements and expert communication come together? If so, please read on…

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 applying our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer an outstanding 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.

The Labeling Strategy Associate Director (LSAD) is responsible for developing and implementing the global labeling strategies for assigned developmental and commercialized products within the V&I portfolio. The LSAD applies their knowledge of global and local labeling requirements and trends to ensure that crucial information regarding the safe and effective use of our products is available to healthcare professionals and their patients.

What you’ll do…

• Lead the development of the labeling 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

• Lead all aspects of the Product Labeling Team (PLT) developing and maintaining 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

• Provide labeling 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 labeling regulations and guidance
• Lead the development of labelling negotiation strategies, anticipating HA perspectives
• Provide clarity regarding applicable labeling requirements, expectations, risks and mitigations for sophisticated situations to relevant collaborators
• Evaluate, interpret and communicate global regulations and trends on labeling and any business impact these might have on product labeling
• Develop and communicate the rationale for labeling strategies to Senior Leaders to enable effective decision making
• Lead the development of target product labelling documents
• Support the development of the labeling group by sharing knowledge and mentoring peers
• Assist in the development of labeling policies, procedures and SOPs

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in a science or related field
• Significant experience, including regulatory experience, in the pharmaceutical industry or at a health authority, preferably working with labeling
• Knowledge of labeling regulations and guidance
• 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 mitigate risk
• Demonstrate proficiencies in forming relationships, interpersonal awareness, critical information seeking, rational persuasion and negotiations skills.

Desirable

• Experience in labeling development or maintenance for vaccines or other antibacterial/antiviral products
• Advanced academic degree (PharmD, PhD) or specialized training

Why AstraZeneca

With our ground-breaking pipeline, the outlook is forward-thinking. Be proud to be part of a place that has achieved so much yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

Where can I find out more

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.