Associate Director, Global Regulatory Labeling

POSITION SUMMARY: 

Global leader (assigned to a Therapeutic Area, product or portfolio) with responsibility for:

• The creation and maintenance of primary and derived labeling documents, and text for artwork for packaging components through the LWG and LC processes, as required

• Ensuring quality of primary and derived labeling documents, and text for artwork for packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents)

• Contribution to and implementation of the global labeling strategy including the development of target labeling

• Continuous improvement of the end to end labeling process

Principle Responsibilities, include:

Principal responsibilities may vary depending on level of employee.

Principal responsibilities may include but are not restricted to the following and may vary depending on labeling experience and Therapeutic Area, product or portfolio assignments as determined by the Global Labeling Therapeutic Area Head:

• Responsible for the creation and maintenance of primary (Core Company Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)) and derived (International Package Insert, labeling text for EU, US and international package components, and translations) labeling documents. Takes into account competitor labels when drafting labeling text.

• Coordinates the development, revision, review and approval of primary and derived labeling documents including the Labeling working Group (LWG) and Labeling Committee (LC) activities related to these documents

• Ensures dissemination of LC-approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation

• Ensures quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents)

• Contributes to the continuous improvement of the end to end labeling process

• Contributes to and implements the global labeling strategy including the development of target labeling

Director level: may lead the development of target labeling to inform late stage drug development and to facilitate discussions with EU and US Health Authorities

Required Leadership Competencies:

• Integrity And Credo-Based Actions required (lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for p

• Collaboration and Teaming required (puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires followership; instills a global mindset; champions best practices)

• Results and Performance Driven required (assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value)

• Self-Awareness And Adaptability required (resilient; has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable)

• Sense of Urgency required (proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed)

• Big Picture Orientation With Attention To Detail highly desired (able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed)

• Director level: Strategic Thinking required (driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; motivated to leave things better than they were; a change agent)

Technical Competencies & Knowledge: 

• Labeling expertise with in-depth knowledge of labeling regulations globally (EU, US and International (e.g., Council for International Organizations of Medical Sciences (CIOMS)) highly desired

• Therapeutic area and product knowledge and expertise, and understanding of drug development process highly desired

• Strategic understanding of labeling including implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components; in depth understanding of what data would be required to support a labeling statement and the most appropriate placement of specific text within the labeling; understanding of relationship between labeling and product commercialization highly desired

• Ability to use labeling business systems (including labeling document management system and other...

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