Medical Writing Specialist (home-based)
2 days left
- Experience Level
- Experienced (non-manager)
Hobson Prior are looking for a Medical Writing Specialist for a home-based opportunity across the UK. This is an exciting opportunity to join a world-wide biopharma organisation where you will contribute to the global clinical development of ground-breaking medicines for the treatment of patients with severe diseases.
- Accountable to manage and perform QC of clinical submissions documents which includes data verification, verification of document completeness and consistency within a document and between related documents, spelling and grammar checks (as needed), reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles.
- To provide QC support to writing functions to ensure timely, high-quality deliverables in compliance with Standard Operating Procedures, FDA, EMEA, ICH, and national and local regulations, as applicable.
- 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.
- 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 and review for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.
- Excellent written and verbal communication skills.
- Robust problem-solving capabilities and organizational skills.
- Exceptional proofreading skills.
- Demonstrated ability to work without close supervision.
- Ability to work within an international team setting.
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
- Must be detail-oriented, thorough, and methodical.
- Bachelor's degree.
- A professional certification (eg, AMWA, EMWA, RAPS, BELS) is a plus, but not essential.
- At least 5+ years' experience performing quality checks to medical writing functions.
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
- 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 (eg, Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content.
- Strong computer skills; proficiency in MS Office Suite, and EDMS.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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