Skip to main content
Search roles

Labelling Strategy Director

Location Boston, Massachusetts, United States Job ID R-203326 Date posted 07/10/2024

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 aLabelling 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?

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.

10001196 F RGPD

We’ll keep you up-to-date

Sign up to be the first to receive job updates.

Interested InSearch for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.