Home United States Associate Director Senior Global Labeling Strategist
Home United States Associate Director Senior Global Labeling Strategist
Associate Director Senior Global Labeling Strategist
at CSL Behring
in
United States
Posted on January 9, 2024
Job details
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
- 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.
- 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. It’s 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!
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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. </p><p> 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. </p><p></p><h2><b> The Role </b></h2><p><b> Main Responsibilities and Accountabilities: </b></p><p>1. 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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. </p><p>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. </p><p>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. </p><p>8. Remains up to date with the global labeling requirements and expectations. </p><p>9. Represents Global Labeling in internal and external meetings. </p><p>10. Builds effective, networks with GRA (regional and global) as well as across departments within R&D and Commercial Development. </p><p>11. Leadership: leads by example, role modeling Driving Performance, Building Productive Teams, and Creating the Future – consistent with CSL's Leadership Values. </p><p>12. Miscellaneous </p><p><b> Driving Performance </b></p><ul><li> Sets clear expectations/goals self aligned with CSL Company Objectives </li><li> Holds self accountable for performance and contributions </li><li> Ensures operational efficiencies that contribute to our bottom line </li></ul><p><b> Building Productive Teams </b></p><ul><li> Partners with the Director, GL Strategy to support selection and onboarding of qualified candidates (both internal and external) for open positions </li><li> Builds a productive, engaging team culture and climate within project teams based on trust, respect, and mutual support </li><li> Clarifies project team roles, goals, mission, and ground rules </li><li> Builds networks with other CSL teams to support business objectives ("One CSL")</li><li> Uses appropriate approaches to build virtual, cross-cultural, and cross-functional teams to support assigned portfolio. </li></ul><p><b> Creating the Future </b></p><ul><li> Serves as a role model for CSL's Values </li><li> Lives CSL's mission, vision, and strategy and develops action plans to lead strategy execution </li><li> Is dedicated to fulfilling the needs of internal and external customers and stakeholders </li><li> Fosters innovation and continuous improvement </li></ul><p></p><h2><b> Your skills and experience </b></h2><p> Education </p><p> University degree (4 year degree) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, PhD or Pharm D) preferred. </p><p> Experience </p><p> Minimum of 10 years of biotech/pharmaceutical industry experience. This is inclusive of 6 years of labeling/regulatory experience combined with other global responsibility. </p><p> Experience leading teams in a matrix organization is expected and previous experience managing team members is advantageous. </p><p> Competencies </p><ul><li> Knowledge of principles of regulatory relevant to drug development, global labeling and post-marketing requirements. </li><li> Scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content </li><li> Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions. </li><li> 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. </li><li> Organizational skills to interact seamlessly both internally and externally on strategic and scientific matters. </li><li> 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. </li><li> Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact. </li><li> Attention to detail, coupled with the ability to think strategically. </li><li> Fluency in English (verbal and written)</li></ul><p></p><h2><b> Our Benefits </b></h2><p> 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. </p><p></p><h2><b> About CSL Behring </b></h2><p> 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 . </p><p></p><h2><b> We want CSL to reflect the world around us </b></h2><p> As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. 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This course will provide you with a comprehensive understanding of Accounting Skills through key ideas, strategies, and in-depth information. This course will teach you real-world information and expertise from industry professionals and practitioners.<br> <br> This course is fully an online course; you can start your learning from anywhere in the world. All you need is just a smartphone, tablet, laptop or any other device with an internet connection.<br> <br> After successfully completing the course, you will gather all knowledge about this course, and you will get a recognition PDF certificate which is free of cost (price included in the course price). The certificate will enable you to add more value to your CV in order to stand out in the employment market or job market. In short, the Title Course is the ideal course for advancing your career. So, what are you holding out for? Enrol the course now!<br> <br> <strong>Special Offer</strong> <ul> <li>Learner will get Free Certificate</li> <li>No Extra fees</li> <li>Lifetime Course Access</li> </ul> <strong>Why Choose the Team Building course?</strong> <ul> <li>Developed by Qualified Professionals With Updated Materials</li> <li>24/7 Learning Support and Assistance</li> <li>Course completion free PDF certificate</li> <li>High-quality E-learning Study Materials</li> <li>No Hidden Fees or Exam Charges</li> <li>Access the Course Anywhere in the World</li> <li>Self Paced Learning and Laptop, Tablet, Smartphone Friendly</li> </ul> <strong>Team Building Training<br> <br> Course Curriculum<br> <br> Module 01: Being a Teams</strong> <ul> <li>What is a Team?</li> <li>Types of Teams</li> <li>Making Connections</li> </ul> <strong>Module 02: Increasing Team Norms</strong> <ul> <li>Characteristics of Teams</li> <li>Advantages of Teams</li> <li>Disadvantages of Teams</li> <li>Ground Rules</li> <li>Team Contracts</li> <li>Sample Team Contract</li> </ul> <strong>Module 03: Working as a Team</strong> <ul> <li>No need for Black & White Thinking</li> <li>Degrees of Support</li> </ul> <strong>Module 04: Your Team Player Type</strong> <ul> <li>What's Your Team Player Type?</li> <li>What Does It Mean To Have a Number?</li> <li>My Team Style</li> </ul> <strong>Module 05: Building Team Trust</strong> <ul> <li>Why is Trust Important</li> <li>Building Trust</li> </ul> <strong>Module 06: The Stages of Team Development</strong> <ul> <li>Stage One: Forming</li> <li>Stage Two: Storming</li> <li>Stage Three: Norming</li> <li>Stage Four: Performing</li> <li>Stage Five: Adjourning</li> <li>Forming An Effective Team</li> <li>Making Connections</li> </ul> <strong>Module 07: Virtual Teams</strong> <ul> <li>What are Virtual Teams</li> <li>Strategies of Virtual Team Success</li> <li>Scheduling and Conducting Team Meetings</li> <li>Team Building in a Virtual Environment</li> <li>Informal Bonding Interaction</li> </ul> <strong>Module 08: Communication</strong> <ul> <li>Defining Communication</li> <li>Role of Communication</li> <li>Listening Skills</li> <li>Tips for Becoming a Better Listener</li> </ul> <strong>Module 09: Becoming a Good Team Player</strong> <ul> <li>Becoming a Good Team Player</li> </ul> <strong>Certification</strong><br> <br> By the successful completion of the course, the learner will instantly receive an E-Certificate, which is free of cost. In addition, our courses provide you with up-to-date industry knowledge and skills, aiming to make you an expert in the field.', 'outline' => '', 'who_should_take_this_course' => '', 'career_path' => 'Team Manager,Team Leader,Operations Manager,Team Strategic manager', 'eligibility' => '<br /> There is no special requirements, anyone can take this course all you need is a smart device (smart phone, tablet, laptop or computer) with internet connection so that you can access the course from anywhere in the world.', 'school' => 'Course Line', 'keywords' => 'Team Player,Virtual Team,Team Building,Team Leader, Team Building', 'location' => 'Online', 'duration' => 'Upto 2 Hours', 'timing' => '', 'cost' => null, 'discount' => '95% Off for Laimoon Users!', 'eligibility_criteria' => '', 'job_matching_keywords' => 'Team Building', 'boosted' => '0', 'lang_code' => 'en', 'status' => 'active', 'auto_translated' => '0', 'objectives' => null, 'photo' => null, 'photo_cta' => null, 'video' => null ), 'Profile' => array() ) ) $job = array( 'Job' => array( 'id' => '39309183', 'contact_id' => '3773199', 'recruiter_id' => '74726', 'job_function_id' => null, 'title' => 'Associate Director Senior Global Labeling Strategist', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => '<h2><b> The Opportunity </b></h2><p> 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. </p><p> 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. </p><p></p><h2><b> The Role </b></h2><p><b> Main Responsibilities and Accountabilities: </b></p><p>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. </p><p>2. Contributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books. </p><p>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). </p><p>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. </p><p>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. </p><p>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. </p><p>8. Remains up to date with the global labeling requirements and expectations. </p><p>9. Represents Global Labeling in internal and external meetings. </p><p>10. Builds effective, networks with GRA (regional and global) as well as across departments within R&D and Commercial Development. </p><p>11. Leadership: leads by example, role modeling Driving Performance, Building Productive Teams, and Creating the Future – consistent with CSL's Leadership Values. </p><p>12. Miscellaneous </p><p><b> Driving Performance </b></p><ul><li> Sets clear expectations/goals self aligned with CSL Company Objectives </li><li> Holds self accountable for performance and contributions </li><li> Ensures operational efficiencies that contribute to our bottom line </li></ul><p><b> Building Productive Teams </b></p><ul><li> Partners with the Director, GL Strategy to support selection and onboarding of qualified candidates (both internal and external) for open positions </li><li> Builds a productive, engaging team culture and climate within project teams based on trust, respect, and mutual support </li><li> Clarifies project team roles, goals, mission, and ground rules </li><li> Builds networks with other CSL teams to support business objectives ("One CSL")</li><li> Uses appropriate approaches to build virtual, cross-cultural, and cross-functional teams to support assigned portfolio. </li></ul><p><b> Creating the Future </b></p><ul><li> Serves as a role model for CSL's Values </li><li> Lives CSL's mission, vision, and strategy and develops action plans to lead strategy execution </li><li> Is dedicated to fulfilling the needs of internal and external customers and stakeholders </li><li> Fosters innovation and continuous improvement </li></ul><p></p><h2><b> Your skills and experience </b></h2><p> Education </p><p> University degree (4 year degree) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, PhD or Pharm D) preferred. </p><p> Experience </p><p> Minimum of 10 years of biotech/pharmaceutical industry experience. This is inclusive of 6 years of labeling/regulatory experience combined with other global responsibility. </p><p> Experience leading teams in a matrix organization is expected and previous experience managing team members is advantageous. </p><p> Competencies </p><ul><li> Knowledge of principles of regulatory relevant to drug development, global labeling and post-marketing requirements. </li><li> Scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content </li><li> Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions. </li><li> 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. </li><li> Organizational skills to interact seamlessly both internally and externally on strategic and scientific matters. </li><li> 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. </li><li> Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact. </li><li> Attention to detail, coupled with the ability to think strategically. </li><li> Fluency in English (verbal and written)</li></ul><p></p><h2><b> Our Benefits </b></h2><p> 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. </p><p></p><h2><b> About CSL Behring </b></h2><p> 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 . </p><p></p><h2><b> We want CSL to reflect the world around us </b></h2><p> As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. 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