Labelling Strategy Director

Boston, MA, United States

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

We are hiring a Labelling Strategy Director that will provide regulatory labelling expertise and guidance, typically for more complex drug projects and across a Therapy Area (TA)/Disease Area (DA), to Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labelling Teams (PLT). The Labelling Strategy Director responsibilities will be aligned to a TA and/or DA, and this individual will contribute to developing and shaping the strategic direction of the labelling component of the regulatory strategy for complex projects and/or disease areas.

Locations: Boston, MA

What You'll Do

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 and/or the disease area, 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 (CPI), 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 and/or across the disease area 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 stakeholders, 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 and supports other Labelling Strategists in the TA as appropriate.

Assist in the development of labelling policies, procedures and SOPs.

Is a visible, approachable leader and role model within and outside of Labelling teams.

Coach or may lead a team of Labelling members, providing guidance and support to the individuals as required depending on their level of experience to ensure appropriate Labelling support across all allocated projects.

Effectively deputise for the SDGM as required.

Essential for the role

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 guidelines

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 for the role

Advanced academic training is highly desirable (PharmD, PhD)

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have multiple seats available and we hope one of them is yours!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedI 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

Our dedicated Biometrics page https://careers.astrazeneca.com/biometrics

Date Posted

25-Jun-2024 Closing Date

18-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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