Kelly Science, Engineering, Technology & Telecom
Manager RA Global Labeling Project Leader
Kelly Science, Engineering, Technology & Telecom, Raritan, New Jersey, us, 08869
Manager RA Global Labeling Project Leader
Type of Role:
The Manager, Individual Contributor is responsible for the development and maintenance of primary and derived labeling documents. This position ensures quality of primary and derived labeling documents and ensures adequate support for the documents. This role contributes to and participates in the global labeling strategy, including the development of target labeling.
Impact (Outcomes) of Decision-Making:
The Manager, Individual Contributor makes recommendations that impact the development, revision, review, agreement, and maintenance of primary and derived labeling documents for the assigned compounds. This position makes decisions that impact the resolution of any labeling issues with potential impact on the primary or derived labeling, and as applicable, to the supporting documentation. The Manager, Individual Contributor provides advice and guidance to team about labeling content, processes, timelines, and scientific integrity.
Knowledge/Skills:
Sound scientific knowledge.
Understanding of labeling regulations globally (EU, US and International, e.g., Council for International Organizations of Medical Sciences (CIOMS)).
Understanding of drug development, including the therapeutic area(s) and individual product knowledge.
Awareness of the implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components.
Understanding of what data is required to support a labeling statement and the most appropriate placement of specific text within the labeling.
General awareness of the commercial impact of labeling.
Competent in the use of labeling business systems (including labeling document management system) and other tools used in support of labeling compliance.
Supervision:
The Manager, Individual Contributor is supported and supervised by a Sn Manager, Associate Director, Director. This position works as a team member with colleagues and external contractors across functions. This role influences team members (such as leading the Labeling Working Group meetings), without authority over them and leads discussion at the Labeling Committee.
Illustrative Responsibilities:
Participates in the development and maintains primary and derived labeling documents, depending on complexity. Considers competitor labeling when drafting labeling text.
Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes.
Collaborates with partners (GLO, GRA) to disseminate LC-agreed CCDS, USPI, EUPI and derived labeling documents and supporting documentation.
Works with other functional areas, GLO/TQC, GRA to ensure high quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
Liaises with third party companies on product-specific labeling-related issues, as required.
Contributes to the continuous improvement of the end-to-end Global Labeling process.
Provides input to and implements the global labeling strategy including the development of target labeling.
Supports the GL CoE during audits and inspections and the management of labeling CAPAs as required.
Requirements:
Bachelor's Degree required
4+ years of pharmaceutical or health authority experience
3 years of Regulatory Affairs experience in product labeling/labeling regulations
1 year of experience in leading teams within a matrix environment
Technical, scientific, or regulatory writing experience
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Management, Strategy/Planning, and Quality Assurance
Industries:
Staffing and Recruiting and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x
Kelly Science, Engineering, Technology & Telecom provided pay range
$95,000.00/yr - $130,000.00/yr
#J-18808-Ljbffr
The Manager, Individual Contributor is responsible for the development and maintenance of primary and derived labeling documents. This position ensures quality of primary and derived labeling documents and ensures adequate support for the documents. This role contributes to and participates in the global labeling strategy, including the development of target labeling.
Impact (Outcomes) of Decision-Making:
The Manager, Individual Contributor makes recommendations that impact the development, revision, review, agreement, and maintenance of primary and derived labeling documents for the assigned compounds. This position makes decisions that impact the resolution of any labeling issues with potential impact on the primary or derived labeling, and as applicable, to the supporting documentation. The Manager, Individual Contributor provides advice and guidance to team about labeling content, processes, timelines, and scientific integrity.
Knowledge/Skills:
Sound scientific knowledge.
Understanding of labeling regulations globally (EU, US and International, e.g., Council for International Organizations of Medical Sciences (CIOMS)).
Understanding of drug development, including the therapeutic area(s) and individual product knowledge.
Awareness of the implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components.
Understanding of what data is required to support a labeling statement and the most appropriate placement of specific text within the labeling.
General awareness of the commercial impact of labeling.
Competent in the use of labeling business systems (including labeling document management system) and other tools used in support of labeling compliance.
Supervision:
The Manager, Individual Contributor is supported and supervised by a Sn Manager, Associate Director, Director. This position works as a team member with colleagues and external contractors across functions. This role influences team members (such as leading the Labeling Working Group meetings), without authority over them and leads discussion at the Labeling Committee.
Illustrative Responsibilities:
Participates in the development and maintains primary and derived labeling documents, depending on complexity. Considers competitor labeling when drafting labeling text.
Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes.
Collaborates with partners (GLO, GRA) to disseminate LC-agreed CCDS, USPI, EUPI and derived labeling documents and supporting documentation.
Works with other functional areas, GLO/TQC, GRA to ensure high quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
Liaises with third party companies on product-specific labeling-related issues, as required.
Contributes to the continuous improvement of the end-to-end Global Labeling process.
Provides input to and implements the global labeling strategy including the development of target labeling.
Supports the GL CoE during audits and inspections and the management of labeling CAPAs as required.
Requirements:
Bachelor's Degree required
4+ years of pharmaceutical or health authority experience
3 years of Regulatory Affairs experience in product labeling/labeling regulations
1 year of experience in leading teams within a matrix environment
Technical, scientific, or regulatory writing experience
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Management, Strategy/Planning, and Quality Assurance
Industries:
Staffing and Recruiting and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x
Kelly Science, Engineering, Technology & Telecom provided pay range
$95,000.00/yr - $130,000.00/yr
#J-18808-Ljbffr