MQO Quality Systems Technical Writer - 12 Months Contract – Bracknell (Remote)

Inside IR35 £30.00/hr via umbrella company

Remote, on site as and when required

Essential – Experienced Medical Writer with expertise in Good Pharmacovigilance Practice (GVP). The ideal candidate will have a strong background in medical writing, specifically in creating SEQS safety documents (procedures, required tools & resource documents) related to pharmacovigilance activities, & possess the ability to build robust document architecture. Bachelor’s degree in a relevant field, such as technical writing or life sciences. 3 years of experience in technical writing with a focus on GVP-related documents or related roles in a pharmaceutical or biotech environment. Experience using Veeva QualityDocs or other electronic document management systems (EDMS) preferred. Ability to manage multiple projects & priorities simultaneously.

The Technical Writer is responsible for supporting the Medicines Quality Organization (MQO) Quality Systems team to deliver high quality documents in the Safety & Efficacy Quality System. The Technical Writer will support document changes within the Safety & Efficacy Quality Systems (SEQS), working closely with colleagues in Quality Systems, Global Patient Safety (GPS) & other components of the Research & Development (R&D) organization.
The Technical Writer is responsible for developing & maintaining accurate, clear, & concise procedures, required tools, & resource documents. The role is also responsible for quality checks of the quality system documents to ensure compliance with the clients standards & procedures. The role manages workflows & metadata in the document control system using Veeva QualityDocs.

Responsibilities

1.          Quality Systems Document Management

• Ensure timely delivery of error-free, high-quality documents that meet international standards of written English:
• Develop & maintain accurate, clear, & concise procedures, required tools, & resource documents using appropriate technical writing standards, templates, & style guides. Correct errors in grammar, style, formatting, & syntax.
• Verify quality system architecture accuracy & consistency of content within & between related documents.
• Document Architecture:
• Design & implement document architecture for SEQS safety documents (procedures, required tools & resource documents), ensuring clarity, coherence, & adherence to regulatory requirements.
• Document Control:
• Launch templates & manage document metadata.
• Support MQO Quality Systems with editing, Quality Checks, & data integrity review.
• Ensure the accuracy & completeness of document control records, including document revision histories, revisions, approvals, & related metadata.
• Track status, milestones, & associated documentation throughout the workflow.
• General expectations:
• Maintain a strong customer focus.
• Communicate effectively.
• Manage activities efficiently & proactively to achieve timelines.
• Cross-functional Collaboration: Work closely with the Global Patient Safety (GPS) team to gather information & incorporate feedback into the SEQS document development.
• Timeline Management: Develop & manage timelines for document creation, ensuring timely completion & delivery of high-quality documents.
• Maintain proficiency in applicable software, tools, processes, & workflows.

Candidates must be eligible to work in the UK

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.