Labeling Strategy Associate Director Mississauga, ON (hybrid 3x a week) At AstraZeneca, we pride ourselves on crafting 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 offices are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.  Introduction to role: The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers. Accountabilities: Ensures that the labelling process is followed through the lifecycle of the product. Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs. Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of 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 AZ portfolio. Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling. Leads the development of labelling negotiation strategies, anticipating HA perspectives. Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance. Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant collaborators, including risk insight and proposing mitigations Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling Ensures appropriate communication across Labelling subfunctions Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making. Leads the development of target labelling documents as appropriate Assist in the development of labelling policies, procedures and SOPs Essential Skills/Experience: University Degree in Science or related discipline 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labelling Knowledge of labelling regulations and guidances Excellent verbal and written communication skills Keen attention to detail and accuracy Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. Ability to assimilate clinical and scientific information and present it in a concise manner Ability to think strategically, appropriately assess risks and formulate strategies to manage risk Must demonstrate competencies in: Building Relationships (works well across formal and informal networks) Negotiation Skills (good listener; able to build a consensus) Critical Information Seeking (works well across formal and informal networks) Rational Persuasion (able to distil an issue to its key components and suggest solutions) Interpersonal Awareness (aware of how actions affect other people) Desirable: Experience in Labelling development and/or maintenance Knowledge of major markets Labelling regulations Advanced academic training is highly desirable (PharmD, PhD) Great People want to Work with us! Find out why:  GTAA Top Employer Award for 10 years  Top 100 Employers Award  Canada’s Most Admired Corporate Culture  Learn more about working with us in Canada  View our YouTube channel  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 [email protected].  ⠀ Annual base salary for this position ranges from 133,311.20 to 174,970.95. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program. We are using AI as part of the recruitment process. This advertisement relates to a current vacancy. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Labeling Strategy Associate Director.

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