Associate Director, Global Labeling Strategy (Harrisburg)
Otsuka America Pharmaceutical Inc., Harrisburg, Pennsylvania, United States, 17124
Job Summary
As the Associate Director of Global Labeling Strategy, you will play a pivotal role in collaborating with various teams across the organization to develop and maintain high-quality global labeling for our products. Your expertise will help ensure compliance with regulations while driving continuous improvement in our labeling processes. You will deliver essential labeling documents and artwork for complex drug products, always aiming for excellence and precision.
Key Responsibilities
Lead the Global Labeling Strategy by preparing, reviewing, and updating content for the Company Core Data Sheet (CCDS) and local labeling components.
Coordinate the cross-functional labeling team for assigned compounds, ensuring strategic alignment on labeling content.
Collaborate with Global Regulatory Affairs to ensure that all labeling aligns with the global product strategy.
Assess and communicate risks associated with updates to CCDS content and implementation strategies.
Oversee the development and maintenance of package labeling through effective team collaboration.
Support global health authority interactions regarding all aspects of labeling, including submissions and responses to inquiries.
Maintain an in-depth understanding of labeling requirements to ensure all documentation is accurate and compliant.
Analyze competitor labeling to inform our strategies and improve our content.
Assist in the creation and submission of Structured Product Labeling (SPL) documents, ensuring drug listings and registrations are accurate.
Manage labeling documents within document management systems, ensuring timely reviews and approvals.
Contribute to labeling sections of various reports, including Annual Reports and PSURs.
Participate in inspection readiness activities related to global labeling components.
Represent Global Labeling on relevant regulatory and cross-functional teams.
Partner with colleagues, affiliates, and alliance partners worldwide as needed.
Communicate effectively with senior management and stakeholders to facilitate labeling development.
Propose continuous improvements to Global Labeling processes and policies.
Perform additional responsibilities as required.
Qualifications Required: MS/BS in life sciences or a related scientific field.
6-8 years of relevant experience in a pharmaceutical regulatory or labeling environment.
Knowledge of scientific principles and regulatory systems related to drug development.
Experience in drafting CCDS and local labeling for new products.
Preferred: Strong understanding of labeling regulatory requirements and guidance.
Awareness of the global implications of labeling in a pharmaceutical context.
Experience managing multiple complex projects simultaneously.
Ability to work independently and collaboratively, leading cross-functional teams effectively.
Strong communication skills, with attention to detail and strategic thinking capabilities.
Proficient in IT systems, especially Regulatory Information Management Systems and document management systems.
Action-oriented and customer-focused, with the capacity to navigate ambiguity and foster creative solutions.
Competencies Accountability for Results:
Focus on strategic objectives and lead high-performance standards.
Strategic Thinking & Problem Solving:
Consider long-term impacts in decision-making processes.
Patient & Customer Centricity:
Keep customer needs as a top priority in all initiatives.
Impactful Communication:
Convey ideas clearly and persuasively while respecting others.
Respectful Collaboration:
Value diverse perspectives to achieve shared goals.
Empowered Development:
Actively engage in professional growth as a business priority.
The salary range for this position is between $164,530.00 and $245,985.00, with additional incentive opportunities based on experience and qualifications. Company Benefits:
Our comprehensive benefits package includes medical, dental, and vision coverage, life insurance, disability insurance, tuition reimbursement, student loan assistance, generous 401(k) matching, flexible time off, paid holidays, and other perks. Otsuka is an equal opportunity employer. We encourage all qualified applicants to apply regardless of race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, or any other legally protected characteristic. For assistance with your application, individuals with disabilities may request reasonable accommodations.
Coordinate the cross-functional labeling team for assigned compounds, ensuring strategic alignment on labeling content.
Collaborate with Global Regulatory Affairs to ensure that all labeling aligns with the global product strategy.
Assess and communicate risks associated with updates to CCDS content and implementation strategies.
Oversee the development and maintenance of package labeling through effective team collaboration.
Support global health authority interactions regarding all aspects of labeling, including submissions and responses to inquiries.
Maintain an in-depth understanding of labeling requirements to ensure all documentation is accurate and compliant.
Analyze competitor labeling to inform our strategies and improve our content.
Assist in the creation and submission of Structured Product Labeling (SPL) documents, ensuring drug listings and registrations are accurate.
Manage labeling documents within document management systems, ensuring timely reviews and approvals.
Contribute to labeling sections of various reports, including Annual Reports and PSURs.
Participate in inspection readiness activities related to global labeling components.
Represent Global Labeling on relevant regulatory and cross-functional teams.
Partner with colleagues, affiliates, and alliance partners worldwide as needed.
Communicate effectively with senior management and stakeholders to facilitate labeling development.
Propose continuous improvements to Global Labeling processes and policies.
Perform additional responsibilities as required.
Qualifications Required: MS/BS in life sciences or a related scientific field.
6-8 years of relevant experience in a pharmaceutical regulatory or labeling environment.
Knowledge of scientific principles and regulatory systems related to drug development.
Experience in drafting CCDS and local labeling for new products.
Preferred: Strong understanding of labeling regulatory requirements and guidance.
Awareness of the global implications of labeling in a pharmaceutical context.
Experience managing multiple complex projects simultaneously.
Ability to work independently and collaboratively, leading cross-functional teams effectively.
Strong communication skills, with attention to detail and strategic thinking capabilities.
Proficient in IT systems, especially Regulatory Information Management Systems and document management systems.
Action-oriented and customer-focused, with the capacity to navigate ambiguity and foster creative solutions.
Competencies Accountability for Results:
Focus on strategic objectives and lead high-performance standards.
Strategic Thinking & Problem Solving:
Consider long-term impacts in decision-making processes.
Patient & Customer Centricity:
Keep customer needs as a top priority in all initiatives.
Impactful Communication:
Convey ideas clearly and persuasively while respecting others.
Respectful Collaboration:
Value diverse perspectives to achieve shared goals.
Empowered Development:
Actively engage in professional growth as a business priority.
The salary range for this position is between $164,530.00 and $245,985.00, with additional incentive opportunities based on experience and qualifications. Company Benefits:
Our comprehensive benefits package includes medical, dental, and vision coverage, life insurance, disability insurance, tuition reimbursement, student loan assistance, generous 401(k) matching, flexible time off, paid holidays, and other perks. Otsuka is an equal opportunity employer. We encourage all qualified applicants to apply regardless of race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, or any other legally protected characteristic. For assistance with your application, individuals with disabilities may request reasonable accommodations.