Hobson Prior are currently in search for a Technical Writer to join a global biopharma organisation who are focused on changing the lives of patients living with severe diseases. This role will on a permanent basis and will require you to work from home.

Job Responsibilities:

• To deliver expertise on process, content, checklists, efficiencies, timelines, and interdependencies.
• 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.
• To use functions of Electronic Document Management Systems and Please Review for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.
• You will continue to 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.
• You will collaborate 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.
• To provide QC support to writing functions to guarantee timely, quality deliverables in compliance with Standard Operating Procedures, FDA, EMEA, ICH, and national and local regulations, as applicable.

Key Skills:

• Demonstrated ability to work without close supervision.
• Ability to work within an international team setting.
• Ability to work under pressure.
• Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.

Requirements:

• Bachelor's degree.
• Intermediate understanding of applicable regulations and guidelines including CTD structure and content, CSR and summary document content.
• Strong computer skills; proficiency in MS Office Suite, and EDMS.
• Five or more years' experience performing quality checks to medical writing functions.
• A professional certification (eg, AMWA, EMWA, RAPS, BELS) is a plus, but is not essential.

Apply now:

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.