Senior Medical Writer
- Experience Level
- Experienced (non-manager)
Hobson Prior are looking for a Senior Medical Writer to focus on the global clinical development of innovative medicines for the treatment of patients with severe diseases. This position is on a contract basis, located in Slough.
Please note that to be considered for this role you must have the right to work in this location.
- You will manage and complete QC of clinical submissions documents which contains data verification, verification of document completeness and consistency within a document and between related documents, spelling and grammar checks, reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles.
- Have excellent knowledge on process, content, checklists, efficiencies, timelines, and interdependencies.
- Organise with other Medical Writing Specialists as needed to continue consistency across documents within a project and across indications. Recognise trends in quality deficiencies and recommend corrective actions.
- You will deliver QC support to writing functions to ensure timely, first-class deliverables in compliance with Standard Operating Procedures, FDA, EMEA, ICH, and national and local regulations, as applicable.
- Use functions of Electronic Document Management Systems 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.
- Educated at a Bachelor's degree.
- A professional certification (eg, AMWA, EMWA, RAPS, BELS) is a plus, but not essential.
- Five or more years' experience performing quality checks to medical writing functions.
- Ability to focus on the details in a document without losing sight of the document messaging.
- Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process.
- Intermediate understanding of applicable regulations and guidelines including CTD structure and content, CSR and summary document content.
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
- Must be detail-oriented, thorough, and methodical.
- 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.