Quality Control Specialist
2 months ago
Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.
We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya's vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.
To learn more about us, visit www.excelya.com.
Exceya is looking for collaborating with a Quality Control Specialist (Medical Writing), for a part-time position, based in India. The position is full remote and excellent knowledge of English language is required for this role.
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.
Skills:
- 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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