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Sr Project Manager (Global Labeling)

Orange County Metro Area, CA

Posted: 07/23/2019 Job Type: Engineering Job Number: JN -072019-25260

Job Description

Sr Project Manager (Global Labeling)
Lifesciences Industry
Costa Mesa, CA

Essential Job Functions:
  • Manage enterprise-wide project to implement EUMDR labeling through the Global Supply Chain
  • Facilitate the creation and approval of complex business cases within the program, and coordinates the sharing of resources among projects
  • Establish, maintain, and influence program stakeholder relationships, expectations, and communications, both internal and external to the organization
  • Develop a high-level integrated milestone plan for the project and manages program change in accordance with the change management plan to control scope, quality, schedule, cost, and contracts
  • Execute project plans (quality, risk, communication, staffing, etc.) and capture and communicate program status and data in order to maintain accurate and current information for the use of stakeholders
  • Obtain approval for the project and actively manage project benefits and issues in partnership with business partner
Required Skills:
  • Eight or more years experience in Supply Chain practices, Labeling, Packaging, Quality Engineering, and Project Management with greater than 5 years experience in the Medical Device industry
  • Five years experience implementing computer systems in Medical Device Industry
  • Five years experience with labeling applications and processes, including familiarity with software validation quality procedures.
  • Five years experience in a regulated environment, FDA, DEKRA, TUV
  • Proven record of delivering business impact
  • Proven expertise in usage of MS Office Suite and related project management systems
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Experience within a regulated environment
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including interactions with higher, equivalent and lower level internal and external representatives concerning projects, area decisions, scheduling requirements and/or driving contractual clarifications
Education:
  • Bachelor's Degree
  • PMP Certification Required
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