Associate Director, Sr. Global Labeling Expert at CSL Limited in King Of Prussia, PA
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/pharmace
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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/pharmace
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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