What are the responsibilities and job description for the Labeling Manager position at Donatech Corporation?
Position would require the candidate to be a W2 employee of Donatech.
US Citizenship/Permanent Resident Required.
Principal responsibilities include, but are not restricted to:
• Chairs/leads the Labeling Working Group (LWG), and presents to Executive Labeling Board the labeling documents review/governance
• Represents labeling on product-specific global regulatory teams
• Leads the development and maintenance of core labeling documents including Core Data Sheet(CDS), core patient information leaflet (CPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and Medication guide. Manages products with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends impacting the LWG and across the regulatory organization.
• Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents
• Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies
• Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are escalated appropriately.
• Contributor to strategic creation of target product labeling
• Assists in preparation of responses to labeling-related Health Authority queries including supporting Packaging Component Labeling
• Manages the review and approval of core DHCP letters
• Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.
Preferred Qualifications:
• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Knowledge of labeling within a Therapeutic Area
• Knowledge of FDA, or EMA, or other international regulations for labeling
• Understanding the impact of emerging trends and their implications for client
• Project Management experience, experience managing individual and group projects of moderate complexity
• Strong collaboration, presentation, communication, interpersonal, and leadership skills
• Experience working in a Veeva/Documentum-based document management system
Basic Qualifications:
Doctorate degree
OR Master’s degree and 2 years of related experience
OR Bachelor’s degree and 4 years of related experience
OR Associate’s degree and 10 years of related experience
OR High school diploma / GED and 12 years of related experience
Knowledge & Skills:
• Knowledge of global labeling regulatory requirements, standards and processes
• Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area
• Analytical thinking
• Ability to develop solutions that are thorough, practical, and consistent with functional objectives.
• Strong collaboration, interpersonal and negotiation skills.
• Demonstrable conflict resolution and negotiation skills
• Meeting facilitation and presentation skills
• Attention to detail, time management, organizational skills
• Excellent verbal, and written communication skills.
• Strong technical writing skills
• Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint
US Citizenship/Permanent Resident Required.
Principal responsibilities include, but are not restricted to:
• Chairs/leads the Labeling Working Group (LWG), and presents to Executive Labeling Board the labeling documents review/governance
• Represents labeling on product-specific global regulatory teams
• Leads the development and maintenance of core labeling documents including Core Data Sheet(CDS), core patient information leaflet (CPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and Medication guide. Manages products with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends impacting the LWG and across the regulatory organization.
• Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents
• Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies
• Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are escalated appropriately.
• Contributor to strategic creation of target product labeling
• Assists in preparation of responses to labeling-related Health Authority queries including supporting Packaging Component Labeling
• Manages the review and approval of core DHCP letters
• Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.
Preferred Qualifications:
• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Knowledge of labeling within a Therapeutic Area
• Knowledge of FDA, or EMA, or other international regulations for labeling
• Understanding the impact of emerging trends and their implications for client
• Project Management experience, experience managing individual and group projects of moderate complexity
• Strong collaboration, presentation, communication, interpersonal, and leadership skills
• Experience working in a Veeva/Documentum-based document management system
Basic Qualifications:
Doctorate degree
OR Master’s degree and 2 years of related experience
OR Bachelor’s degree and 4 years of related experience
OR Associate’s degree and 10 years of related experience
OR High school diploma / GED and 12 years of related experience
Knowledge & Skills:
• Knowledge of global labeling regulatory requirements, standards and processes
• Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area
• Analytical thinking
• Ability to develop solutions that are thorough, practical, and consistent with functional objectives.
• Strong collaboration, interpersonal and negotiation skills.
• Demonstrable conflict resolution and negotiation skills
• Meeting facilitation and presentation skills
• Attention to detail, time management, organizational skills
• Excellent verbal, and written communication skills.
• Strong technical writing skills
• Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint
Salary : $44 - $54
