Project Manager with Labeling Management Exp

TechSpace Solutions Inc.
Jerseycity, NJ
25 Nov 2024

Vacancy expired!

JD:The Labeling Management System Lead is accountable to develop, maintain, and optimize an enterprise-level capability for the E2E management of Client product labeling/artwork digital system strategy. The Lead is accountable to ensure that the labeling digital system capability meets multiple business process and regulatory compliance requirements and supports the utilization and maintenance of labeling content in an effective and compliant manner. To achieve this, the Lead is accountable for identifying and incorporating business needs into a long-range strategy to meet business objectives; and driving the definition and design of business processes and tools to execute on this strategy. The Lead is responsible for ensuring coherence and continuity across the enterprise-wide regulatory systems (content management, health registration management, submission planning, artwork management, etc) with labeling-specific systems. The Lead will also work cross-divisionally to ensure consistency with upstream and downstream labeling processes. The Lead drives initiatives across R&D functional areas including at the HQ, regional and country level, strategic operations and cross-divisionally with Manufacturing and Marketing. The Lead works across the business digital management team to optimize functioning of the labeling process, including the evaluation of new systems or functionalities in existing systems. The Lead interfaces with functional area leads across the enterprise where data dependencies exist (BiDashbord, Artwork management system). The Lead ensures adequate documentation to support the labeling process and inspections and audits. The Lead supports the labeling process in the event of an agency inspection or internal audit. Below are additional responsibilities of the Lead.
  • Establish and maintain culture in R&D that supports compliance with labeling process management and innovation to drive continuous improvement of the system and processes.
  • Develop and deliver training on labeling systems, and become a single point of contact for queries raised by end users related to labeling systems across HA and Country RA.
  • Lead large-scale change initiatives across R&D, Manufacturing, and Marketing related to the labeling process.
  • Develop labeling process capabilities including regulatory-, system-, and business process knowledge.
  • Ensure alignment cross-functionally outside of R&D and throughout the enterprise to develop and improve enterprise-wide process optimization.
  • Manage Change Control of the labeling processes and associated systems.
  • Manage Business Requirements and partner with IT to develop systems requirements
  • Oversee user acceptance testing preparation and execution for new system/upgrade evaluation; communicate and lead Change Management of system initiatives
  • Drive process development and improvement projects ensuring system and process performance and capabilities.
  • Collaborate cross-divisionally to ensure system effectively enables regulatory business processes.
  • Drive Demand Management for system, process, and data changes, and data clean-up.
  • Manage a Portfolio of change initiatives within organization and alignment with the larger R&D Change Management Portfolio.
  • Together with Business Digital Management, partner in the evaluation of performance metrics to determine where process changes, communication, and training may be needed to improve overall quality
  • Ensure processes are clearly documented, communicated, and understood.
  • Support functional areas to ensure system training and documentation meet business needs.
  • Ensure reporting tools meet the requirement to prepare and run reports for compliance monitoring, audit and inspections and audit remediation.

Education Requirement:
  • Bachelor’s degree with 7+ years of industry experience, preferable in a regulatory/ compliance area and experience with technical systems in a regulated environment.
  • Master’s Degree and a minimum of 5 years of industry experience preferable in a regulatory or labeling compliance area and experience with technical systems in a regulated environment

Required Experience and Skills
  • Broad range of knowledge of regulatory and labeling processes as well as overall knowledge of the end-to-end labeling processes, systems, and business requirements.
  • Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools
  • Knowledge of document management and/or structured content management as it applies to change control, content reuse, and labeling processes
  • Knowledge of system development lifecycle and data administration concepts
  • Demonstrated experience assessing and enabling process change.
  • Ability to lead and influence others outside of a direct reporting relationship
  • Broad organizational awareness and knowledge of touch points/interdependencies,
  • Demonstrated Change Management Knowledge
  • Process Management Knowledge (e.g., Six Sigma Green Belt)
  • Project Management Skills
  • Demonstrated capabilities managing and mentoring staff
  • Demonstrated collaborative skills and ability to work in cross-functional and international environments.

Desired Experience and Skills
  • Advanced knowledge and capabilities applying technology within a business environment
  • Sigma Black Belt, Change Management Certification, PMI Certification.
  • Experience supporting and working with tools and systems used in the Regulatory Affairs environment