Description:

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.

Accountabilities/Responsibilities:

• 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 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 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 as appropriate

Additional information: Preferably 5 days/week (Monday-Friday), 8 hours per day. Remote position.

Top priorities: Labeling expertise in Core Data Sheet, EU/US labelling experience, Ability to lead teams and labeling negotiations with Health authorities (e.g FDA, EMA).

Minimum requirements:

• 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)

Preferred site - Gaithersburg MD

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Find what’s next with Kelly ® .

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.