Senior Medical Document Review Specialist
2 weeks ago
Excelya is a renowned Contract Research Organization (CRO) in Europe, founded in 2014 and headquartered in Paris. Our global team comprises over 900 experts who deliver high-quality trial solutions across various therapeutic areas.
We adopt a collaborative approach to work, where our collective success is the result of seamless collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Our vision at Excelya is to drive innovation in the field of healthcare and excel in research development. We aim to empower our clients in delivering life-changing therapies collaboratively, thus transforming tomorrow together and establishing ourselves as the clinical research leader in Europe.
For our team members, excelling with care means benefiting from a stimulating professional environment that fosters personal, intellectual, and operational growth, enabling us to be the best in our field. We commit to providing each Excelyate with the means to express their unique talents, develop their full potential, and invest their individuality in our distinctive projects.
To learn more about us, please visit www.excelya.com.
Excelya is seeking an experienced Quality Control Specialist (Medical Writing) for a part-time position, based in India. This role is fully remote, and an excellent command of the English language is essential for this position.
Responsibilities:
- 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.
Key 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.
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