To review and edit medical writing and clinical regulatory documents (including, but not limited to clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, common technical document submissions, Investigator Brochures, Lay Summaries as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) according to the sponsors’ and Excelya’s SOPs.
To perform quality control activities, ensuring the accuracy of all information, data, and references for the documents/tables/figures/listings produced, also reviewing spelling, grammar, appropriateness of language, correct mention of links to other part of the document or other documents, and compliance to industry guidelines.
To check information in the document against the data source (internal consistency within a document and across documents).
To deliver documented quality review comments or checklists to the document’s author through resolution, while interacting with the Medical Writers and other team members to resolve QC findings.
Minimum Requirements :
University graduate in life sciences or equivalent (post-graduate studies in a relative field are considered a plus).
Relative experience 1-5 years as a QC Specialist/Editor, Copyeditor, or Medical Writer of clinical regulatory documents (such as clinical study reports, protocols) is considered a plus.
Advanced level of English, both written and verbal
Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines.
Analytical skills and ability to interpret data.
Attention to detail.
A strong work ethic.
Intellectual curiosity and creativity.
The ability to work effectively in a team in a fast-paced and dynamic environment.
