Associate Director, Sr. Global Labeling Expert

The CCDS Owner drives the creation and maintenance of the development Company Core Data Sheets (dCCDS) and the Company Core Data Sheets (CCDS) of CSL Behring products as assigned by the CCDS Owner, Therapeutic Area Lead.

Position Purpose:

The Associate Director, Senior Global Labeling Expert (Sr. GLE) acts as the principal labeling strategist within Global Regulatory Affairs. The Sr. GLE drives the creation and maintenance of the development Company Core Data Sheet (dCCDS), the Company 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 optimal alignment of the company position, labeling requirements, and commercial opportunities. As a seasoned expert, provides strategic input into the GRA Therapeutic Area Team from a labeling perspective.

The Sr. GLE ensures that the company 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.

Main Responsibilities and Accountabilities:

1. Generates and maintains the development Company Core Data Sheet (dCCDS), the Company Core Data Sheet (CCDS), the USPI and the EU SmPC as assigned. Delivers 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. Ensures consistent communication to the Global Labeling Associates (GLAs), regions and countries regarding new and updated CCDSs for Therapuetic Area

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

7. Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams (GRASTs), GRA Therapeutic Area (TA) teams and ensures that an effective 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, cross-functional networks with GRA (regional and global) as well as across functions 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/objectives for 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 highly-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”)
• When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams in support of 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 drive strategy execution
• Is dedicated to fulfilling the needs of internal and external customers and stakeholders
• Challenges the status quo; fosters innovation and continuous improvement
• Applies business acumen skills to help grow the business

Position Qualifications and Experience Requirements:

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 and understanding of principles of regulatory relevant to drug development, global labeling and post-marketing requirements.
• Strong 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, particularly 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 implications 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. It’s important and so are you. Learn more about how we care at CSL.

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.

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