Associate Director Senior Global Labeling Strategist

Associate Director Senior Global Labeling Strategist

The Opportunity

The Associate Director, Senior Global Labeling Strategicst (Sr. GLS) acts as the principal labeling strategist within Global Regulatory Affairs. The Sr. GLE guides the creation and maintenance of the development Company Core Data Sheet (dCCDS), our Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for CSL Behring's product portfolio, as assigned, to ensure understanding of the company position, labeling requirements, and commercial opportunities. As a expert, you will provide strategic input into the GRA Therapeutic Area Team from a labeling perspective.

The Sr. GLE ensures that our company's core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the dCCDS/CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC.

The Role

Main Responsibilities and Accountabilities:

1. Creates and maintains the development of the Company Core Data Sheet (dCCDS), our Core Data Sheet (CCDS), the USPI and the EU SmPC as assigned. provides the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory, registration and development strategy.

2. Contributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books.

3. For the dCCDS/CCDS, leads the interactions with relevant Subject Matter Experts (SMEs) and stakeholders, such as Global Clinical Safety and Pharmacovigilance (GCSP), Global Clinical Development (GCD), Global Regulatory Affairs (GRA) and Commercial Development and Operations (CDO).

4. For the USPI and EU SmPC, collaborates with the Regional Regulatory Therapeutic Area leads the review of these labels and respective, interaction with relevant SMEs.

5. Leads the assessment and Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the USPI and SmPC using established departmental processes and maintaining compliance. Escalates differences and compliance issues to the Director, Global Labeling Strategy and labeling governance bodies.

7. Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams (GRASTs), GRA Therapeutic Area (TA) teams and ensures that a communication pathway exists between the GRAST, TA teams and Global Labeling.

8. Remains up to date with the global labeling requirements and expectations.

9. Represents Global Labeling in internal and external meetings.

10. Builds effective, networks with GRA (regional and global) as well as across departments within R&D and Commercial Development.

11. Leadership: leads by example, role modeling Driving Performance, Building Productive Teams, and Creating the Future consistent with CSL's Leadership Values.

12. Miscellaneous

Driving Performance

• Sets clear expectations/goals self aligned with CSL Company Objectives
• Holds self accountable for performance and contributions
• Ensures operational efficiencies that contribute to our bottom line

Building Productive Teams

• Partners with the Director, GL Strategy to support selection and onboarding of qualified candidates (both internal and external) for open positions
• Builds a productive, engaging team culture and climate within project teams based on trust, respect, and mutual support
• Clarifies project team roles, goals, mission, and ground rules
• Builds networks with other CSL teams to support business objectives ('One CSL')
• Uses appropriate approaches to build virtual, cross-cultural, and cross-functional teams to support assigned portfolio.

Creating the Future

• Serves as a role model for CSL's Values
• Lives CSL's mission, vision, and strategy and develops action plans to lead strategy execution
• Is dedicated to fulfilling the needs of internal and external customers and stakeholders
• Fosters innovation and continuous improvement

Your skills and experience

Education

University degree (4 year degree) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, PhD or Pharm D) preferred.

Experience

Minimum of 10 years of biotech/pharmaceutical industry experience. This is inclusive of 6 years of labeling/regulatory experience combined with other global responsibility.

Experience leading teams in a matrix organization is expected and previous experience managing team members is advantageous.

Competencies

• Knowledge of principles of regulatory relevant to drug development, global labeling and post-marketing requirements.
• Scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content
• Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions.
• Must work well with others and within global teams with the ability to build partnerships, cross-cultural exposure. Experience collaborating in a complex and matrix environment is required.
• Organizational skills to interact seamlessly both internally and externally on strategic and scientific matters.
• Proficient regulatory and drug/biologic development (pre-clinical to post-clinical) knowledge including an understanding of broad scientific concepts within labeling and their possible effects across the organization and globally.
• Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact.
• Attention to detail, coupled with the ability to think strategically.
• Fluency in English (verbal and written)

Our Benefits

We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!