SRG are currently recruiting an Associate Director Labelling Strategy on a 6-month contract basis for our client who are a large global pharmaceutical organisation
The Global 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 marketed or pipeline products. The individual contributes to the development of the labelling group by sharing knowledge and mentoring peers.
- 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 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 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 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 Global Labelling Group sub functions
- 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
- Assist in the development of labelling policies, procedures and SOPs
Qualifications and Experience:
- University Degree in Science or related discipline where advanced academic training is highly desirable (PharmD, PhD)
- Experience in Labelling development and/or maintenance
- Knowledge of major markets Labelling regulations
- 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
If you are interested to find of more, please apply directly or contact email@example.com or 07384 836 266
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