Technical Writer III #JN -062021-65856

Memphis, Tennessee
Industry: Technical Writer / Content writer
Job Number: JN -062021-65856

Description:

  • Experience in technical, legal, research writing, along with planning/coordination experience. 3 to 3+ years’ experience in Technical writing preferred. Bachelor degree preferred but extensive technical writing experience could suffice in lieu of degree
  • This Technical Writer will provide coordination, tracking, and planning for all document approvals for a large tech transfer project. This role will review and edit a large volume of documents in order to ensure proper grammar, font, alignment, references to steps, etc. Documents may include Standard Operating Procedures, Validation Protocols, Forms or Logsheets, Policies, and any other GMP-related document.
  • This role will work closely with Document Control Specialists and the Operations’ authors/owners. In addition, this role will work closely with the lead Project Manager. All documents reviewed must be accepted by QA oversight in order to have the capability to receive FDA and Health Canada Approvals

 Specific Project Assignments:

  • Project tracking and coordination in relation to documents
  • All technical writing relating to the tech transfer into Project Ft Worth

 Summary of Essential Job Functions:

  • Supports the Workstream Leads in the creation and optimization of the GMP documents,
  • Ensures all project tracking is consolidated in one master project plan
  • Works with Operations, Research & Development, Quality and Regulatory Affairs, Procurement and other stakeholders to deliver upon the project scope and timeline

 Essential Experience/Education Requirements:

  • Experience in technical, legal, research writing, along with planning/coordination experience

 Abilities Required:

  • Adherence to Quality Systems and Good Manufacturing Practices with proper attention to detail
  • Demonstrated ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant
  • Excellent verbal and written communication skills
  • Software: MS Office Suite, Word and Outlook (Basic Excel knowledge / Strong Word knowledge.)
  • Ability to work within an electronic document management system
  • Understanding of FDA and Health Canada regulatory requirements
  • No travel required


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