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Technical Writer, Document Author, Document Writer

Role Description

We are seeking an experienced Quality Document/Technical Documentation Writer who is familiar with the Pharmaceutical industry, specifically one with Computer System Validation skills.

We require the writer to author multiple unfinished work products/deliverables across multiple M&A projects – e.g. Migration Plan, Migration Approach, Migration Reports. Project details and specifics will be provided to the writer by the Project Manager who oversees the work.

The deliverables (i.e. work products/technical documents produced by the writer) will be reviewed by the Project Manager & IT Quality Manager in-house for any corrections and/or edits required until a final version of the document is approved. Necessary work product templates & outline descriptions/tools will be provided to the writer.

Key to Note

Work product templates are already in place that adhere strictly to company standards. In other words: the writer does not need to author work products from scratch.

• GxP standards & regulations

• Understanding of CFR Part11 & Pharma Regulations

• Pharmaceutical industry experience

• Validation skills

• Technical Document writing skills

• Understanding of how to work with Quality Management

• Ability to deal with ambiguity and achieve clarity.

Навыки: Написание технических текстов, Research Writing, Написание отчетов, Content Audit, Аудит, Academic Medicine, Медицина, Medical Products, Medical Research, Медицинские тексты

О клиенте:
( 3 отзыв(-а, -ов) ) Macclesfield, United Kingdom

ID проекта: #34715729