Labelling Strategy Director

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

The Labelling Strategy Director provides 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. 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 has a key role in the development of the labelling group by sharing knowledge and mentoring peers, and supports and advises the respective Senior Director Group Manager (SDGM) to ensure appropriate project and resource planning. The Labelling Strategy Director will coach or may serve as a line manager for Labelling members in the group and in conjunction with SDGM will be involved in hiring, training, coaching, and career development of staff

**Typical 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 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 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)

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