Non-Medical Technical Writing Support Project

 

Data Science and Regulatory Affairs
  • Area: Greater Chicago Area
  • Key Account Manager: Brandon Clough
  • Project Type: Technical Writing

About this Project

OBJECTIVE

Required non-medical technical writing support.

 SERVICES

PSC provided the client with non-medical technical writing support including Data Science and Regulatory Affairs focused, a Pharmacovigilance process improvement initiative, and other Clinical Science process improvement efforts. Non-medical technical writing activities include the development, maintenance, and revisions of documents connected with Good Clinical Practice (GCP), Quality, Regulatory and Non-Regulatory expectations, Standard Operation Procedures (SOP) and other processes, and Document Impact Assessments. Over a duration of time, in-scope non-medical technical writing projects were expected to vary in number, size, complexity, and non-medical subject matter which were discussed between PSC project team and project sponsor(s) when assigned the writing project to PSC.

non-medical technical writing

Brandon Clough

Director, Business Development & Operations

BClough@biotech.com

sales@biotech.com

non-medical technical writing

EQUIPMENT USED

  • Microsoft Office Documentum module (ADMS – an internal document repository)
  • PEAK (Process Excellence and Knowledge – process map software)
  • Adonis (similar to PEaK)
  • SAP S/4 + MDG module

PROJECT SUCCESS

The PSC project team comprised of 6 Technical Writers, one of which was a Project Manager. The team successfully produced the non-medical technical writing project deliverables based on an agreed timeline with the client over the course of 8 months.

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