Project Manager, Global Labeling

  • location: Wayne, PA
  • type: Contract
  • salary: $45 - $49 per hour
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job description

Project Manager, Global Labeling

job summary:
The Project Manager will lead the implementation of GLS system to execute a standard process and system for Business Units (BUs) and Global Supply Chain function. This position requires a candidate with the ability to manage a broad set of activities and resources.

 
location: Wayne, Pennsylvania
job type: Contract
salary: $45 - 49 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Lead and manage a team to transition site from current processes and systems for label design and change management to the developed GLS system.
  • This includes standardisation of processes for labels created for External and Purchased Finished Goods manufacturers.
  • Lead data migration activities to migrate data and create artworks as part of the rollout of GLS system.
  • Develop and manage the data migration plans for the label design site with understanding of requirements for External and Purchased Finished Goods manufacturers.
  • Lead and manage data migration resources to meet site schedules for creation of artworks.
  • Lead and manage implementation of future state print processes in line with developed GLS system.
  • Work with SMEs, site leads and functions to integrate GLS system into the site while minimizing impact to the business as part of cutover.
  • Provide updates, reports, monitor KPIs and identify risks for site data migration in line with overall project plan.
  • Present updates via Powerpoint on status and risks for data migration and label creation.
  • Ensure proper communication of project at site level in partnership with operations, quality, regulatory, planning and marketing to ensure project success.
  • Adhere to and ensure the compliance of Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
  • Support other activities as required.
 
qualifications:
  • 4 - 5 years' experience in highly regulated industry or medical device, pharma or similar industry with experience leading large projects.
  • Engineering, Science or other appropriate 4 year degree.
  • Project management skills and experience.
  • People management skills and experience.
  • Experience in labeling for medical devices for label design and operations.
  • Ability to accurately scope projects and consider the full impact of decisions and actions taken.
  • Ability to work well under deadlines and pressure.
  • Effective communicator of issues, of facts and ideas/solutions to senior members of the organization.
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously.
  • Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
  • Good business acumen.
  • Displays ownership of results and a drive to achieve.
  • Attention to detail and accuracy - essential.
  • Manage personnel directly or indirectly to achieve the objectives of the project.
  • Self-motivated to achieve compliant results.
  • Must be fluent in English both written and oral.
 
skills: FDA, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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