Medical QA Writer for Biopharma

Writing Assistance

Medical QA Writer for Biopharma Remote, USA

Job Ref: JOB-47279

WAI is a nationwide staffing agency. Currently we are looking for 3-5 Quality Assurance (QA) Medical Writers for our client (full-time, remote work) through the end of the year. We are looking to document (create templates, update and fix exiting) Quality Documentation for our Biopharmaceutical client. They specialize in the area of neurology and ophthalmology pharmaceuticals. The large push is to fix their “Quality Event” documents (similar to CAPAs or deviation documents). • Requisite skills: strong technical writing, ideally in a quality context, and ideally with prior Quality Event authoring experience • The key focus on Quality Event authoring. The organization has hundreds of quality events, with more expected. To date, these have been authored inefficiently. We are looking to create, edit and update in MS Word. Storing the documentation in VIVA. Functional areas for Quality Event authoring are: o TechOps and change controls (manufacturing/ analytical/ supply chain) o CDRA/ regulatory affairs o Pharmacovigilance and clinical science o Early R&D and non-clinical science focus (potential including IT) o Quality • These authors would sit (virtually) with their respective SMEs and review their existing content, and ensure QEs are written in a stronger fashion, and helping to re-author these QEs describing the requisite details (i.e. the who, what, where and when), and help to review and re-author these QEs • Ultimately, the revised QEs may be incorporated into a training program

Tagged as: Medical QA Writer for Biopharma