Labeling Strategy Associate Director

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)

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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 AZCHumanResources@astrazeneca.com .

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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.

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This advertisement relates to a current vacancy.