Regulatory Quality Assurance Specialist
13 hours ago
Excelya is a leading Contract Research Organization (CRO) in Europe, founded in 2014 with its headquarters in Paris. With over 900 experts globally, the company provides trial solutions across various therapeutic areas. Excelya's one-team approach to work ensures that collaboration is at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
The company's vision is to achieve new advances in healthcare and expertise in research development. Its goal is to help clients deliver life-changing therapies collaboratively, becoming the clinical research leader in Europe. For team members, excelling with care means benefiting from a stimulating professional environment that encourages personal, intellectual, and operational participation.
Excelya is committed to giving each team member the means to express their natural talents, develop their full potential, and invest their unique selves in projects. To learn more about the company, visit our website. The company is currently looking for a Regulatory Quality Assurance Specialist for a part-time position based in India. This role is full remote and requires excellent knowledge of the English language.
Responsibilities:
- Review and edit medical writing and clinical regulatory documents according to sponsors' and Excelya's SOPs.
- Perform quality control activities, ensuring accuracy and compliance with industry guidelines.
- Check information in documents against data sources for internal consistency.
- Deliver documented quality review comments or checklists to authors through resolution, interacting with Medical Writers and other team members to resolve QC findings.
Requirements:
- University graduate in life sciences or equivalent.
- Relative experience as a QC Specialist/Editor, Copyeditor, or Medical Writer of clinical regulatory documents.
- 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 and strong work ethic.
- Intellectual curiosity and creativity.
- Ability to work effectively in a team in a fast-paced and dynamic environment.
Estimated Salary: ₹600,000 - ₹800,000 per annum, depending on experience.
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