Labeling Project Manager

A Labeling Project Manager job is available through IntePros. Candidates will be responsible for coordinating the development of Technical Literature. Candidates will be supporting the Print Solution, and Core Team members, working cross-functionally to develop timelines and take content change needs for the Instructions for Use or (IFU) back to the Technical Literature team for execution to meet the needs for human factors testing, regulatory submissions and product launches. This person will be working closely with a matrixed team in the department consisting of graphic designers, project coordinators and technical writers to deliver high-quality technical literature to support the Diabetes Operating Unit.

This is a 1-year Contract.

This is a remote opportunity.

This job will pay up to $75 hr. D.O.Q.

Labeling Project Manager Job Responsibilities Include

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Monitors and improves tracking / control systems.
  
  

Qualifications

• Must have at least a Bachelors and 5 plus years of experience with Technical Literature, IFU, and Labeling. Or a minimum of 3 years of experience with advance degree.
• Accountability, this person should have a high say/do ratio and be able to work with other team members in a matrix to support business needs.
• Organizational skills, this person should be able to manage multiple interrelated projects simultaneously, identify critical path and propose multiple solutions to opportunities to crash schedules when needed.
• Stakeholder management, this person will be the “face” of the department within the Core Team and manage external stakeholders and support the department’s internal team through building a close relationship with a high level of collaboration.
  
  

If you are interested in this Labeling Project Manager job then please click APPLY NOW. For other opportunities available at IntePros go to https://intepros.com/ .If you have questions about the please contact Robert Schemel rschemel@intepros.com .