Labeling Analyst

Location: Somerville, NJ
Date Posted: 10-27-2016
JOB DESCRIPTION-   Labeling Analyst (Pharma/ Medical Devices)
Labeling Analyst will work in collaboration with Client SPOC and all the concerned Stakeholders and will be responsible for below mentioned activities:
  • Understanding and mapping of current labeling process, tools and systems
  • Understand and gather labeling needs of the client
  • Provide SME support to the business stakeholders for labeling solution
  • Provide Labeling Platform Technical expertise
  • Follow up with SMEs and stakeholders to ensure timely inputs and approvals
  • Understanding Global Regulatory requirements of Medical Devices/Pharma Labeling
  • Act as Syntel’s Single Point of Contact (SPOC) for the respective business areas
  • Proactively communicate project status, issues & risk to management.
  • Provides leadership and direction, championing departmental or cross-functional Labeling initiatives.
  • Responsible for the overall Planning, scheduling, estimations, direction, coordination and evaluation of the Labeling process.
  • Use technical/compliance information to guide and influence Labeling Compliance strategies.
  • Responsible for planning, assigning, directing work; addressing Labeling issues and resolving problems.
  • Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to this project.
  • Drive timely execution of Project deliverables through monitoring and reporting status to Labeling owners and management.
  • Create and own Change Orders in PLM to route and release documents
  • Create Summary of Changes
  • Create redlines on artworks and documents of changes and to send to graphic designers.
  • Review with cross functional stakeholders
  • Initiate IFU changes and follow up with vendors including language translations
  • Analyze trends to monitor the effectiveness of the process and drive remediation for improvement
Resource management

At least a bachelor’s degree in Computer Science, Engineering or related field or an equivalent in education is required for this position.
We are an Equal Opportunity Employer.
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