Job Description

Job Title: Labelling Strategy Manager

Career Level - D

Introduction to Role:

The Labelling Strategy Manager provides regulatory labelling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labelling teams, with guidance from the Labelling Strategy Director Group manager. This individual contributes to the development of the labelling strategy and leads the maintenance and implementation 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

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.

Contributes to the development of the labelling strategy, in line with the overall regulatory strategy for the product, applying knowledge and understanding of labelling regulations, guidances and competitor analyses with/under guidance from the TA Labelling Strategy Director Group Manager

Contributes to 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 guidances.

Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling

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.

Provides clarity regarding applicable labelling requirements and expectations to relevant stakeholders, including risk insight and proposing mitigations

Ensures appropriate communication across Labelling subfunctions

Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.

Contributes to the development of target labelling documents, as appropriate under the supervision of the Director

Assist in the development of labelling policies, procedures and SOPs

Essential Skills/Experience:

University Degree in Science or related discipline

Minimum 6 years of 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 Skills/Experience:

Experience in Labelling development and/or maintenance

Knowledge of major markets Labelling regulations

Advanced academic training is highly desirable (PharmD, PhD)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\xe2\x80\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?
At AstraZeneca, we are committed to turning our drug development strategies into reality. We think broadly about patients and what it takes to prevent and treat diseases. We are proactively involved in the strategy, changing the course for approvals and influencing regulators on new technology. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what\'s next. We are part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions.

Ready to make a difference? Apply now and join us in our mission to bring life-changing medicines to patients.

Date Posted 22-Jan-2024

Closing Date 05-Feb-2024

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 authorization and employment eligibility verification requirements.

AstraZeneca