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Project Coordinator II NON IT
Ref No.: 18-03569
Location: Raritan, New Jersey
Start Date / End Date: 07/30/2018 to 07/26/2019
Description:
OPERATIONS MANAGER – INDIVIDUAL CONTRIBUTOR

Type of Role: The Manager, Individual Contributor leads labeling submission planning and implementation activities on behalf of Janssen R&D Global Labeling Centre of Excellence (GL CoE).

Impact (Outcomes) of Decision-Making: The Manager, Individual Contributor makes decisions that have an impact on the planning and implementation of labeling documents. This position makes recommendations that can have an impact on process improvements for standards, processes, technologies, and resourcing.

Accountability/Decision-Making: The Manager, Individual Contributor, makes recommendations and decisions to identify and understand complex problems and recommends, effective, compliant solutions within a global organization. This position works independently and as a member of a team when making recommendations and decisions.

Knowledge/Skills:
• Proficient in MS Office Suite and Adobe Acrobat.
• Knowledge of regulatory and supply chain as it relates to labeling development and implementation.
• Knowledge with the business systems and tools relevant to the job, including electronic labeling or artwork management systems.
• Knowledge with US and EU labeling submission types guidance and regulations.
• Knowledge of Company Core Data Sheets and their relationship to local labeling is required.

Supervision Received: The Manager, Individual Contributor reports to the Associate Director or Director. This position works as a member or leader of a team with minimal oversight depending on the project.
Supervision Given: The Manager, Individual Contributor mentors/trains others, as needed.

Operations Specific Competencies: Primarily at the Applying Level.

LSM Common Competencies: Primarily at the Applying Level.

Regulatory Affairs Competencies: Primarily at the Applying Level.
1. Leads the planning and implementation activities for primary labeling (i.e., CCDS, USPI, EUPI) and derived labeling for labeling projects under the responsibility of the GL CoE. This includes planning for:
• Development and/or distribution of CCDS via Core Labeling Change Notifications, including early and clear communication with impacted global stakeholders.
• Provides deliverables for USPI and associated labeling, including SPL, as appropriate.
• Provides relevant documents for submissions for EUPI products, including provision of labeling input for EU response documents.
2. Creates and manages labeling project tracking entries as needed in departmental labeling trackers.
3. Leads Packaging Development teams for the development of new or updated mock-ups and artwork in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, US/EU Regulatory Affairs, CMC Regulatory Affairs, Global Graphic Services, and others as needed.
4. Leads New Product Launch Teams or Supply Chain-led labeling or packaging initiatives on behalf of the GL CoE to provide technical expertise with respect to packaging component text content as well as the requirements for layout and design.
5. Manages US and EU labeling mock-ups for use in submission to Health Authority.
6. Maintains labeling history documents.
7. Obtains and prepares labeling input for US Annual Reports.
8. Manages Labeling Change Controls.
9. Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.
10. Enumerates Global Trade Identification Numbers (GTIN) for Janssen and Patriot Pharmaceutical US-marketed products.
11. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
12. Supports the Legal Department with litigation efforts related to GL CoE managed labeling, as needed.
Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.

Attachments​


Scope
2
3
4
Level
1
Operational
Strategic
Type of Role: The Manager, Individual Contributor leads labeling submission planning and implementation activities on behalf of Janssen R&D Global Labeling Centre of Excellence (GL CoE).

Impact (Outcomes) of Decision-Making: The Manager, Individual Contributor makes decisions that have an impact on the planning and implementation of labeling documents. This position makes recommendations that can have an impact on process improvements for standards, processes, technologies, and resourcing.

Accountability/Decision-Making: The Manager, Individual Contributor, makes recommendations and decisions to identify and understand complex problems and recommends, effective, compliant solutions within a global organization. This position works independently and as a member of a team when making recommendations and decisions.

Knowledge/Skills:
  • Proficient in MS Office Suite and Adobe Acrobat.
  • Knowledge of regulatory and supply chain as it relates to labeling development and implementation.
  • Knowledge with the business systems and tools relevant to the job, including electronic labeling or artwork management systems.
  • Knowledge with US and EU labeling submission types guidance and regulations.
  • Knowledge of Company Core Data Sheets and their relationship to local labeling is required.

Supervision Received: The Manager, Individual Contributor reports to the Associate Director or Director. This position works as a member or leader of a team with minimal oversight depending on the project.
Supervision Given: The Manager, Individual Contributor mentors/trains others, as needed.

Operations Specific Competencies: Primarily at the Applying Level.

LSM Common Competencies: Primarily at the Applying Level.

Regulatory Affairs Competencies: Primarily at the Applying Level.

Illustrative Responsibilities
  1. Leads the planning and implementation activities for primary labeling (i.e., CCDS, USPI, EUPI) and derived labeling for labeling projects under the responsibility of the GL CoE. This includes planning for:
  • Development and/or distribution of CCDS via Core Labeling Change Notifications, including early and clear communication with impacted global stakeholders.
  • Provides deliverables for USPI and associated labeling, including SPL, as appropriate.
  • Provides relevant documents for submissions for EUPI products, including provision of labeling input for EU response documents.
  1. Creates and manages labeling project tracking entries as needed in departmental labeling trackers.
  2. Leads Packaging Development teams for the development of new or updated mock-ups and artwork in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, US/EU Regulatory Affairs, CMC Regulatory Affairs, Global Graphic Services, and others as needed.
  3. Leads New Product Launch Teams or Supply Chain-led labeling or packaging initiatives on behalf of the GL CoE to provide technical expertise with respect to packaging component text content as well as the requirements for layout and design.
  4. Manages US and EU labeling mock-ups for use in submission to Health Authority.
  5. Maintains labeling history documents.
  6. Obtains and prepares labeling input for US Annual Reports.
  7. Manages Labeling Change Controls.
  8. Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.
  9. Enumerates Global Trade Identification Numbers (GTIN) for Janssen and Patriot Pharmaceutical US-marketed products.
  10. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
  11. Supports the Legal Department with litigation efforts related to GL CoE managed labeling, as needed.
  12. Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.
Leadership Imperatives
  • Connect
  • Shape
  • Lead
  • Deliver


Operations Specific Competencies Operations Specific Competencies Factors Proficiency Levels
Product Labeling Execution Labeling Planning and Implementation Applying
Labeling Milestone Tracking Leading
Process Monitoring Applying
Scientific Acumen Scientific Knowledge Applying
Therapeutic Area Knowledge Applying
Therapeutic Area Strategy Applying
Product Knowledge Applying
LSM Common Competencies Shared Competencies Factors Proficiency Levels
Customer Focus Customer Requirements Leading
Customer Satisfaction and Service Leading
Innovation and Transformation Business Process Knowledge and Analyses Applying
Adaptability to Change Leading
Innovative Thinking Applying
Operational Excellence Quality Applying
Timeliness Applying
Resource Management (e.g., People, Budget, Systems) Applying
People Development Developing Others Applying
Personal Development Plan Applying
Talent Management Learning
Team Leadership Establishes and Executes a Vision Applying
Motivates Others Applying
Delegation and Empowerment Applying


Regulatory Affairs Competencies Shared Competencies Factors Proficiency Levels
Applied Technical Knowledge Regulatory Knowledge Leading
Product Lifecycle Development and Management Leading
Continuous Learning Focus Leading
Business Acumen Creates and Executes Strategy Applying
Vision Applying
Business Planning & Execution Applying
Financial Understanding Applying
Project Management Applying
Decision Making and Prioritization Decision Making Leading
Time & Priority Management Leading
Manages Complexity Leading
Organizational Acumen Leading
External Focus Understand the External Environment Applying
Market & Competitive Intelligence Applying
Cultural Awareness Applying
Leading and Influencing Interpersonal Understanding Applying
Shapes the Regulatory Environment Applying
Influences Stakeholders Applying
Negotiation Applying
Collaboration Applying
Persuasive Communication Verbal Communication & Understanding Leading
Active Listening & Conflict Management Leading
Technical Written Communication Leading



Experience
Required
Experience Core Desired
University Degree (i.e., Bachelor's degree). X
6 years relevant experience (including 2+ years health care industry). X
Strong verbal and written communication, negotiation, and partnering skills. X
E2E labeling knowledge. X
Process Improvement knowledge. X
Track record of managing projects through to successful completion. X
Experience successfully working with and/or leading cross-functional teams. X
Experience working with external providers. X
Experience with labeling submission planning and implementation. X
Potential Accelerator Opportunities
  • Take a leadership role in a global process improvement initiative.
  • Lead others in cross-sector projects and activities.
  • Promote positive change management and demonstrate influencing skills.
  • Proactively take challenging assignments outside of immediate responsibilities.
  • Mentor a colleague in a specific area of expertise to enhance their capabilities.
  • Proactively partner in a complex project that has impact across the business.
  • Represent the department on cross-functional projects.
  • Take a leadership role in harmonizing the processes, systems, and practices within the department.
**It is important that you are effective in achieving your current goals and objectives, prior to engaging in accelerator experiences.



Hours per Day 8
Hours per Week 40
Total Hours 2,080.00