Medical Writer Quality Assurance Specialist
3 weeks ago
Excelya, a leading Clinical Research Organization (CRO) in Europe, is seeking a skilled Medical Writer Quality Assurance Specialist to join its team. Based in India and working full-time remotely, this role requires excellent English language proficiency.
About Excelya
With over 900 experts worldwide, Excelya has established itself as a trusted partner for clients across various therapeutic areas. Our one-team approach fosters collaboration and shared success throughout every stage of a project, from regulatory affairs to quality assurance and strategic development.
Our vision at Excelya is to drive innovation in healthcare and research development. We strive to deliver life-changing therapies collaboratively, aiming to become the leading CRO in Europe.
For our team members, excelling with care means being part of a stimulating professional environment that encourages personal growth, intellectual curiosity, and operational participation. We invest in each team member's unique talents, fostering their potential to excel in our dynamic projects.
To learn more about Excelya, please visit our website.
Job Description: Medical Writer Quality Assurance Specialist
This part-time position involves reviewing and editing medical writing and clinical regulatory documents, including clinical study protocols, informed consent forms, clinical study reports, and common technical document submissions. The successful candidate will ensure accuracy, data integrity, and compliance with industry guidelines, working closely with Medical Writers and other team members.
Key Responsibilities:
- Review and edit medical writing and clinical regulatory documents according to sponsors' and Excelya's SOPs.
- Perform quality control activities, ensuring accuracy, data integrity, and compliance with industry guidelines.
- Check information against data sources for internal consistency within documents and across documents.
- 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, with post-graduate studies in a relative field considered a plus.
- 1-5 years of 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, 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.
Estimated Salary Range: ₹600,000 - ₹900,000 per annum
This compensation range reflects the demands of the role, the required expertise, and the location in India. As a remote employee, you will enjoy a high degree of flexibility and autonomy while contributing to Excelya's mission.
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