Biopharmaceutical - Technical Writer

2 months ago


Toronto, Canada MMR Consulting Full time

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

**Previous Pharmaceutical/Biotech experience is mandatory for this role.**

**Responsibilities**:

- Create and edit content at all levels of complexity consistent with current formats and templates.
- Ensure content follows all site standards such as formatting, organization, terminology, etc. Review content provided by others for compliance with GDP (Good Documentation Practices).
- Track progress to ensure on-time completion to meet site timelines.
- Solve complex technical writing, editing, document issues following cGMP regulations.
- Work to establish the templates, metadata and standards required for different document types to ensure consistency for end users.
- Coordinate, assess and own the change management process, including but not limited to the Document Change Record Requests (DCR), Planned Events (PE) and Unplanned Events (UPE) processes.
- Work flexibly to support changing assignments and priorities in an independent and reliable manner, including under tight deadlines.

**Qualifications**
- Education: BA or BS (or equivalent) in English, Biology, Chemistry, Pharmacy, Engineering or equivalent experience.
- 3+ years of previous experience with creating/ updating documents in the biotech or pharmaceutical manufacturing industry is **required**.
- Advanced word processing proficiency in a broad range of technical skills, including advanced use of Google Software **is required** and knowledge of document management systems, quality systems, and collaboration systems (SmartSheets, Trello) is beneficial.
- Ability to write technical documents and training, with attention to detail and consistency, especially with respect to style, format, and layout for visual design simplicity.
- Strong work ethic with drive to complete tasks on time while never compromising safety or quality.
- Dependable/ reliable with excellent communication skills.
- **This is an on-site role.**

**Equal Employment Opportunity and Reasonable Accommodations


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