Technical Writer - Scientific-I

ID# DCOH26725

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW

Labeling Lead Specialist (Technical Writer)

WW Product Labeling – Global Surgery

PURPOSE: 

The Labeling Lead Specialist is responsible for supporting activities related to New Product Development, Lifecycle Management, and Process Improvement projects for Worldwide Product Labeling (WWPL) within a franchise of Global Surgery. 

  • Following established procedures, collaborate with New Product Development teams, Lifecycle Management, and other Subject Matter Experts in the development and implementation of package labeling and IFUs.
  • Drive project schedules and coordinate WWPL resources to ensure on time delivery.
  • Support identification, development, and implementation of new processes and initiatives for package labeling.

EDUCATION / DEGREE REQUIRED: 

  • Minimum undergraduate (BS/BA) required

KEY SKILL / KNOWLEDGE REQUIREMENTS: 

SKILL SETS

  • Strong writing skills
  • Strong communication skills
  • Interdependent Partnering
  1.  Ability to effectively interact and partner with all levels and disciplines within the organization
  2. Ability to conduct meetings, conferences and presentations.
  • Mastering Complexity
  1.  Ability to manage multiple projects competing for resources
  2. Strong analytical and problem-solving skills
  3. Strong Organizational and Prioritization skills
  4. Negotiation and Conflict Resolution Skills
  • Technical/Functional
  1.  Project Management experience
  2. Process Excellence capability
  • Knowledge of:
  1.  Domestic and international legal and regulatory requirements
  2. Domestic & foreign registration requirements
  3. Foreign national laws
  4. Medical Device Directive with respect to European harmonization
  5. Technical writing & / or graphic designing, editing & proofreading & applicable standards
  6. Change management concepts & methods

COMPUTER SKILLS

  • Personal computer skills, MS Office applications, Word, MS Project, Excel, Powerpoint, Adobe InDesign

JOB EXPERIENCE

  • 5+ years of demonstrated Project Management skills
  • 2+ years developing content, protocols, or documentation in a regulated environment

KEY JOB RESPONSIBILITIES:  

  • POLICIES: Know & follow policies & procedures related to work activities performed in area of responsibility
  • TRAINING: Complete training in area of responsibility within allowed time-period.  Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.  Complete required periodic re-training in areas such as safety & environmental
  • SAFETY: Follow all company safety policies & other safety precautions within work area.  Promote safety to all associates that enter work area
  • SUPERVISORY
  1.  May supervise, direct, or mentor co-ops, interns, or contractors.
  2. Work cooperatively with internal/external customers and suppliers.
  • Labeling 
  1.  Lead Labeling Design Changes and New Product Development in partnership with appropriate engineering and impacted functional groups (eg. Regulatory Affairs).  Ensure design inputs are accurately captured in labeling, and labeling content is accurate, consistent, and compliant with all regulations--external and internal—and legal requirements.
  2. Develop and manages the labeling schedule for all NPD and LifeCycle projects to ensure on-time delivery.
  3. Develop Labeling Strategies for labeling projects
  4. Partner with key stakeholders to develop text for all packaging components including IFUs
  5. Partner with illustrator to develop illustrations required on product and package design.
  6. Proofread and edit package labeling for accuracy, completeness, consistency, content, and compliance.
  7. Coordinate review and approval of labeling at all stages.
  8. Coordinates outside services, such as translations, prepress approvals, etc.; supplies artwork and all necessary support documentation; approves Supplier proofs.
  9. Provide management with appropriate recommendations as new technology (design, proofing, etc.) emerges.  Perform cost-benefit analyses.
  10. Support projects to develop and implement new value-added applications/processes and improve existing applications/processes that impact internal and external customers.
  11. Provide partners with cost and timing estimates.
  12. Manage multiple projects
  13. Ensure packaging drawings are updated to reflect labeling changes
  14. Use company-specific documentation systems to manage the storage and release of documents. 
  15. Regularly update stakeholders, Labeling leadership, and Labeling Process Leads on project status.

Position Details:

Medical Device

Scientific

Start Date: 
8-19-2013
End Date: 
12-31-2013

CINCINNATI, OH

CON_W2

37.5

DCOH26725

No

No