Global Medical Writer

CK Clinical are recruiting for a Global Medical Writer to join a biopharmaceutical company based in Slough, Berkshire, on a on a contract basis for 12 months.

The Company:
This company is a world leading pharmaceutical company that focuses on neurology and immunology. Their ambition is to transform the lives of people living with severe diseases.

Location:
Flexible remote/home working is available for this medical writer position. However, once a return to office is feasible, on-site may be required. So while initially remote, candidates should plan on being able to visit the office in Slough in the future.

Rate:
£50-60 per hour, depending on experience (umbrella company option). PAYE working via CK is also available.

Global Medical Writer Role:

- Provide QC support to writing functions ensuring compliance with Standard Operating Procedures (SOPs), FDA, EMEA, ICH, and national and local regulations, as applicable.
- Manage and perform QC of clinical submissions documents such as Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans (as needed), patient narratives, and clinical parts of Investigational Brochures, agency meeting briefing packages, INDs, and responses to agency questions, lay summaries, and redacted documents.
- Provide expertise on process, content, checklists, efficiencies, timelines, and interdependencies.
- Coordinate with other Medical Writing Specialists as needed to maintain consistency across documents within a project and across indications. Identify trends in quality deficiencies and recommend corrective actions.
- Use functions of Electronic Document Management Systems (EDMS) and PleaseReview for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.
- Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the QC of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.

Your Background:

- Bachelor`s degree (Life Sciences preferred).
- A professional certification (e.g. AMWA, EMWA, RAPS, BELS) is a plus, but not essential.
- Five or more years` experience performing quality checks to medical writing functions.
- Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process.
- A high degree of familiarity with statistical and data output.
- Intermediate understanding of applicable regulations and guidelines (e.g. Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content.

Apply:
For more information or to apply for this Global Medical Writer position, please contact CK Group, quoting job ref 48924.

It is essential that applicants hold entitlement to work in the UK.