Medical Writing Specialist
CK Clinical are recruiting for a Medical Writing Specialist to join a biopharmaceutical company, on a contract basis for 12 months as a remote based writer.
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.
- 38-55 per hour PAYE/Umbrella.
Medical Writing Specialist 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.
- Maintain and demonstrate expert knowledge of company- and project-specific guidelines forthe QC of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.
- 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 Please review for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.
- Bachelor's degree (Life Sciences preferred).
- A professional certification (e.g. AMWA, EMWA, RAPS, BELS) is a plus, but not essential.
- Extensive 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 Medical Writing Specialist position, please contact Hendre Moolman on 01438 842 970 or email email@example.com, quoting job ref 49556.
It is essential that applicants hold entitlement to work in the UK.