Pharmaceutical Technical Writer

3 weeks ago

London ON KZ, Middlesex, Canada MMR Consulting Full time
Biopharmaceutical - TECHNICAL WRITER

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).
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the client’s facility in London , ON area.

Technical Writer is responsible for the development, maintenance, and revision of content used by Oceanside Operations. Content includes, but is not limited to, documentation (operating procedures, work instructions, etc), training, posted information (visual aids) and similar which is subject to regulatory (cGMP) requirements. As a subject matter expert, the individual will be a member of the Operational Readiness team and support Manufacturing, Quality, Automation, Facilities & Engineering, and other site teams.

Previous Pharmaceutical Industry experience is mandatory for this role.

Responsibilities:
● Work with subject matter experts within the network to create/ edit/ maintain documents required for Operational readiness activities.
● 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).
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 a technical or regulatory environment and experience in the biotech or pharmaceutical manufacturing industry is required.
Advanced word processing proficiency is required in a broad range of technical skills, including advanced use of Google Software is required and knowledge of document management.
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 with opportunity for some flexible working exceptions.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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