Assoc Princ Specialist Reg Drug Proj Del

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 Client 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 Client 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

• 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

60% onsite requirement